Tuesday, March 30, 2010

Nationwide Voluntary Recall of Masxtreme Capsules, Marketed As a Dietary Supplement

Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker. Aildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). This may pose a threat to consumers because Aildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed Nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.

Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.


Could Statins Raise a Person’s risk for Type 2 diabetes by 9%?

Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. That's the name of a recent study.

From the study:

INTERPRETATION: Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.

Link: http://www.ncbi.nlm.nih.gov/pubmed/20167359

Saudi Government Bans Avandia (Georgia/Florida)

Saudi Arabia has suspended GlaxoSmithKline PLC's (GSK) diabetes drug Avandia for six months, saying the product's heart risks outweigh its benefits, but the U.K.-based drug maker said its stands by the controversial drug.

The Saudi Food and Drug Authority said on its website that the risk of using Avandia, also known as rosiglitazone, "outweighs its benefit, especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures."

It said safer alternatives could be used there instead.

Glaxo responded by saying "the Saudi regulatory authority action is based on a review that did not include the most recent scientific data on Avandia."

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes."

Glaxo now has six months to provide the Saudi drug regulator with evidence of why rosiglitazone and combination products containing it should not be taken off the Saudi market permanently. Rosiglitazone containing products marketed in Saudi Arabia are Avandia , Avandamet and Avandaryl.


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Georgia: Avandia and the Heart: A Reminder That Drugs Can Harm (HP)

From the HuffPo:

Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart.

The recognition that drugs can cause harm is nothing new. A recent example is the painkiller Vioxx which was found to harm the heart and taken off the market in 2004.

While many extremely toxic drugs are eventually taken off the market, several drugs that are quite harmful remain available, albeit with a warning from the FDA. An example is acetaminophen, the active ingredient in some over-the-counter painkillers (such as Tylenol) and many cold medications, which can cause severe liver damage.

If every drug has the potential to cause harm, how can an average person protect himself or herself from the adverse effects of drugs that are approved by the FDA?

The answer is education.


Monday, March 29, 2010

Raw Milk Warning

A bottle of green-top (raw, unpasturised) milk...Image via Wikipedia

The FDA and several Midwestern state health agencies have warned consumers against drinking unpasteurized, raw milk following an outbreak of campylobacteriosis.

About 12 confirmed reports of raw milk related illness was reported on March 24 to the Michigan Department of Community Health, the FDA reported in its announcement of the alert.

Reports say that a variety of infectious bacteria, such as Salmonella and E. Coli, which can cause illness or death might be contained in unpasteurized milk.


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Sunday, March 28, 2010

Georgia and USA: JAMA and Avandia (Heart Attack Claims by Some)

A few years ago, the “New England Journal of Medicine", published a study that identified a potential heart risk with Glaxo’s then-blockbuster diabetes pill, Avandia.

In an editorial in the latest issue of "The Journal of the American Medical Association" or JAMA, Drs. Catherine DeAngelis and Phil Fontanarosa call what happened “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial. The circumstances represent another example of corporate motives apparently outweighing scientific standards and perhaps ethical principles, thereby exposing patients to potential harm.”

Find it here: http://jama.ama-assn.org/cgi/content/full/303/12/1196

From the conclusion:

Given the circumstances surrounding rosiglitazone1-2 and the RECORD trial,10-11 and perhaps other industry-sponsored trials, it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance. This approach would add powerful support to the fundamental principle that physicians must first do no harm.

FOSAMAXImage by flap via Flickr

A new study tries to assure folks about the safety of Fosamax and Reclast. It found that long-term use does not significantly raise the risk of a rare type of fracture near the hip.

The drugs prevent more fractures than any they may cause when used to treat the bone-thinning disease osteoporosis, said the study's leader, Dr. Dennis Black of the University of California, San Francisco.

"If we treated 1,000 osteoporotic women for three years, we estimate you would prevent 100 fractures," at a possible cost of one or fewer of the unusual bone breaks examined in this study, he said.

Researchers combined results from three large studies involving more than 14,000 women who were given Fosamax, Reclast or dummy treatments for three to 10 years.

In all, 284 hip and leg fractures occurred, including 12 of the unusual upper-thigh type. There was a trend toward more of these unusual fractures among bisphosphonate users, but the difference was small enough to have occurred by chance.

From CBS news.

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Saturday, March 27, 2010

FDA and Tanning Beds

A sunbed, with lights offImage via Wikipedia

The FDA is considering new restrictions on indoor tanning. A 16-member panel has advised that children and teens should be barred from tanning beds unless their parents sign a consent form that warns of the dangers of tanning.

The panel seemed likely to advise the FDA to list tanning beds as Class 2 devices, which require special assurances, such as labeling requirements or mandatory performance standards, that they will not cause harm. Class 2 devices include X-ray machines and powered wheelchairs.

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F.D.A. Asks Pediatricians to Stop Using a Diarrhea Vaccine for Now

The FDA has asked the nation’s pediatricians to stop giving children a diarrhea vaccine until federal scientists can figure out why the product contains apparently harmless but extraneous pieces of a pig virus.

The vaccine, called Rotarix, is manufactured by GlaxoSmithKline and is intended to prevent severe cases of rotavirus infections, a diarrheal illness that can cause dehydration in infants and young children.

Reports are that there is no real risk.

Tuesday, March 23, 2010

ESA and Another Review

The Centers for Medicare & Medicaid Services (CMS) will seek advice from a panel of outside experts concerning drugs used by patients with chronic kidney disease, given concerns over possible heart dangers.

The drugs, known as erythropoiesis-stimulating agents (ESAs), have already weathered recent warnings and restrictions over their use in cancer patients that have caused doctors to lower doses.

More here.

When Drug Companies Plead Guilty to Criminal Charges

The Department of Justice building in Washingt...Image via Wikipedia

Article worth reading in the WaPo. Here's an excerpt:

Across the United States, pharmaceutical companies have pleaded guilty to criminal charges or paid penalties in civil cases when the Justice Department finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.

Rest is here.

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Saturday, March 20, 2010

FDA: Zocor Risk to Muscles

ZocorImage by neofedex via Flickr

Based on new data, the FDA warned that higher doses of the cholesterol-lowering drug Zocor, sold generically as simvastatin, carry an increased risk of muscle injury.

The FDA also warns that mixing Zocor with certain other drugs also increases patients' risk of muscle injury, including the rare but serious complication known as rhabdomyolysis. Rhabdomyolysis can sometimes result in fatal kidney damage.

From the FDA site:

Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury

Patients should:

* Not stop taking simvastatin unless told to by their healthcare professional.
* Talk to their healthcare professional about any questions they have about the use of simvastatin.
* Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.

Rhabdomyolysis (often shortened to simply "rhabdo") is the rapid breakdown (lysis) of skeletal muscle (rhabdomyo) due to injury to muscle tissue. The muscle damage may be caused by physical (e.g., crush injury), chemical, or biological factors. The destruction of the muscle leads to the release of the breakdown products of damaged muscle cells into the bloodstream; some of these, such as myoglobin (a protein), are harmful to the kidney and may lead to acute kidney failure.

The damage is more common at the highest approved dose of Zocor, 80 mg. A large clinical trial comparing 6,031 patients taking 80 mg. daily with 6,033 patients taking 20 mg. found 52 cases of myopathy in the 80-mg. group and only one in the 20-mg. group. Eleven patients in the 80-mg. group developed rhabdomyolysis, but none in the low-dose group.

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Georgia: Teen Texting While Driving Ban Passes Senate

In my opinion, it is not the act of talking on...Image via Wikipedia

Officials say teen drivers are easily distracted because of their inexperience on the road. Now lawmakers here are one step closer to banning young drivers from texting while driving.

GA Senate Bill 360 prohibits anyone 18 or younger from using wireless telecommunication devices while driving to text. Here's the bill:

A BILL to be entitled an Act to amend Title 40 of the Official Code of Georgia Annotated, relating to motor vehicles and traffic, so as to prohibit persons 18 years of age or younger from using wireless telecommunications devices for sending or receiving text messages while operating a motor vehicle; to provide penalties for violations; to change certain provisions relating to a driver's exercise of due care; to provide for related matters; to provide for an effective date and applicability; to repeal conflicting laws; and for other purposes.


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Friday, March 19, 2010

Eczema Drugs' (Elidel/Protopic) Warning Labels Should be Expanded - FDA

The FDA is considering expanding the warning labels of the Novartis AG cream Elidel (pimecrolimus) and AStellas Pharma’s Protopic (tacrolimus) used to treat eczema. The drugs already carry a strong warning, called a black box warning, about the increased risk of cancer in children.

The documents, released a head of an FDA advisory meeting, are part of a conference to evaluate potential safety concerns with a variety of drugs used in younger patients.

The FDA has received reports of 46 cancer cases and 71 infection cases in patients aged 16 and younger from 2004 to 2008 with these medications, called topical calcineurin inhibitors or TCI’s.

More here.

Seroquel: Zero Verdict

AstraZeneca officials properly warned a Vietnam veteran’s doctors about the diabetes risk posed by its Seroquel antipsychotic drug, a jury ruled in the first case over the medicine to go to trial.

A state court jury in New Brunswick, New Jersey, deliberated a total of six hours over two days before finding the company’s warnings to Ted Baker’s doctors absolved AstraZeneca of responsibility for his injuries. Baker, 61, took Seroquel for lingering effects of post-traumatic stress syndrome caused by his military service in Vietnam. His was the first of about 26,000 claims over the drug to be considered by jurors.

Read more here.

Tuesday, March 16, 2010

Recall of Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters

It's been a busy week so far for recalls.

Teleflex Incorporated provided an update on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.

Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death. Arrow International has notified the United States Food and Drug Administration (FDA) and other health authorities of this recall.

Consumers who have:

-- any Arrow product with a part number beginning with W followed by five numeric digits (e.g., W12345);

-- any Arrow product with a part number beginning with MPI followed by five numeric digits (e.g., MPI-12345) which is an IV tubing set or tubing set accessory;

-- either of the following two part numbers IV-850001-AAMC and IV-85020-UW


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Heart Device Recall

Logo of the U.S.Image via Wikipedia

The FDA has told health care providers of an ongoing recall launched by Abiomed, Inc for a device that supplies power to a blood pump used on failing hearts.

Abiomed began warning customers in December of a potential defect in some AB5000 circulatory support systems that could cause the computer in the device to shut down the blood pump without any alarm. The company followed this up with a letter dated January 27, that was delivered when company representatives repaired the devices.

Here is info from the FDA site:

Reason for Recall:

The computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.

FDA Comments:

At the start of the recall, the company phoned their customers and followed up with a letter dated January 27, 2010. The sales representatives delivered the letter at the time the product repairs were carried out.


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Arsenic in Apple Juice?

100% Pure Apple Juice (January 27, 2010) [315/365]Image by Brenderous via Flickr

Florida's St. Petersburg Times commissioned an independent lab to test several nationally-recognized brands--Motts, Apple & Eve Organics, Walmart's Great Value, Nestle's Juicy Juice, Minute Maid, Tree Top, Target's Market Pantry--as well as a Tampa Bay company that supplies schools in the area.

The Times reported that samples from three brands--Motts, Apple & Eve Organics, and Walmart's Great Value label--were found to have arsenic levels above the U.S. Food and Drug Administration's (FDA's) level of concern.FDA officials are not currently concerned about the public health risk.

Over 60 percent of apple juice, made from concentrate and consumed in the U.S. is made from apples grown in China and much of the rest is made from apples grown in Chile, Argentina, and Turkey, according to the Times.

More here.

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Video: The Pringles Recall

FDA Orders Two Companies to Stop Marketing Unapproved Nitroglycerin Tablets

nitroglycerineImage via Wikipedia

The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

From the FDA warning letter:

As labeled, the above products are drugs within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because they are intended to affect the structure or function of the body. Further, these drug products, as distributed by your firm, are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. Based upon our information, there are no FDA-approved applications on file for the above products. The marketing of these products without an approved application constitutes a violation of these provisions of the Act

Letters here:



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From The NEJM: To Reduce Diabetes Heart Risks, Diet/Exercise May Beat Drugs

The blue circle symbol used to represent diabetes.Image via Wikipedia

Four new studies published in this week's New England Journal of Medicine bring nothing but disappointing news for diabetics who rely on drugs to lower their risk of heart attacks and strokes.

An estimated 24 million Americans have diabetes, which is the seventh leading cause of death in the United States. Adults with type 2 diabetes are two to four times more likely than adults without diabetes to die from heart disease, and 65 percent of deaths in people with diabetes are from cardiovascular causes.

One study found that using antihypertensives to lower systolic (the top number) blood pressure below a healthful measurement of 120 mm Hg does nothing to lower a diabetic's risk of heart complications; another found no benefit to adding a drug to raise HDL "good" cholesterol levels in diabetics who were already taking a statin to lower the bad kind. N heart benefits were associated with two drugs given to lower high blood sugar levels, according to the two other studies.

One key study is known as ACCORD - one of the largest studies ever conducted in adults with type 2 diabetes who were at especially high risk of cardiovascular events, such as heart attacks, stroke, or death from cardiovascular disease.

The multicenter clinical trial tested three potential strategies to lower the risk of major cardiovascular events: intensive control of blood sugar, intensive control of blood pressure, and treatment of multiple blood lipids. The lipids targeted for intensive treatment were high density lipoprotein (HDL) cholesterol and triglycerides, in addition to standard therapy of lowering low density lipoprotein (LDL) cholesterol. Source.

For a good explanation of the result, go to NEJM and take a look at this report: http://www.medpagetoday.com/MeetingCoverage/ACC/19000

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Monday, March 15, 2010

Analgesic Use and the Risk of Hearing Loss in Men

The Last American AnalgesicImage by webmink via Flickr

From a recent study:

Hearing loss is a common sensory disorder, yet prospective data on potentially modifiable risk factors are limited. Regularly used analgesics, the most commonly used drugs in the US, may be ototoxic and contribute to hearing loss. Ototoxicity is damage to the ear (oto-), specifically the cochlea or auditory nerve and sometimes the vestibular system, by a toxin. Source.

An analgesic (also known as a painkiller) is any member of the group of drugs used to relieve pain (achieve analgesia). The word analgesic derives from Greek an- ("without") and algos ("pain"). Analgesic drugs act in various ways on the peripheral and central nervous systems; they include paracetamol (para-acetylaminophenol, also known in the US as acetaminophen), the non-steroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, and opioid drugs such as morphine and tramadol. Source.

Analgesic drugs include aspirin, acetaminophen (Tylenol), ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), the COX-2 inhibitor celecoxib, and narcotic drugs including morphine, oxycodone, and hydrocodone (Vicodin).

During 369,079 person-years of follow-up, 3488 incident cases of hearing loss were reported. Regular use of each analgesic was independently associated with an increased risk of hearing loss. Multivariate-adjusted hazard ratios of hearing loss in regular users (2+ times/week) compared with men who used the specified analgesic <2 times/week were 1.12 (95% confidence interval [CI], 1.04-1.20) for aspirin, 1.21 (95% CI, 1.11-1.33) for NSAIDs, and 1.22 (95% CI, 1.07-1.39) for acetaminophen. For NSAIDs and acetaminophen, the risk increased with longer duration of regular use. The magnitude of the association was substantially higher in younger men. For men younger than age 50 years, the hazard ratio for hearing loss was 1.33 for regular aspirin use, 1.61 for NSAIDs, and 1.99 for acetaminophen.

Regular use of aspirin, NSAIDs, or acetaminophen increases the risk of hearing loss in men, and the impact is larger on younger individuals.

Here's the link.

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5th Circuit Case Says No Preemption in Generic Reglan Lawsuit

On January 8, 2010, the United States Court of Appeals for the Fifth Circuit held that state law failure to warn claims against generic drug manufacturers are not preempted by federal regulation. Demahy v. Actavis, Inc., 2010 WL 46513 (C.A. 5 (La.).

This decision is consistent with that of the Eighth Circuit in Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009) and was guided by the Supreme Court's decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009), holding that such a claim is not preempted against name brand drug manufacturers.

In Demahy, the drug was the generic form of Reglan (metoclopramide) manufactured by Actavis. Demahy claimed that her long-term ingestion of the drug caused her to develop a neurological movement disorder called tardive dyskinesia. She asserted personal injury claims under the Louisiana Products Liability Act for, among other things, failure to warn of the risks of the drug's long-term use.

The Fifth Circuit rejected the argument that compliance with state duties to warn would burden generic manufacturers with duplicative drug trials, noting that clinical studies are not prerequisites to labeling changes and reports of adverse drug reactions can substantiate the need for a heightened warning. The Fifth Circuit's decision was grounded in the belief that a central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times.

Here's the opinion: Here.

US cost of foodborne illnesses: $152 Billion , 5,000 deaths per year

Dusk at the CDCImage by Nrbelex via Flickr

Food-borne illnesses cost the United States $152 billion a year, a tab that works out to an average cost of $1,850 each time someone gets sick from food, a report by a former Food and Drug Administration economist says. Source.

The three most expensive illnesses for the nation were campylobacter, common in poultry, at $18.8 billion; salmonella at $14.6 billion; and listeria at $8.8 billion. Both salmonella and listeria are found in multiple foods.

There's an interactive map at: http://www.makeourfoodsafe.org/

From the site:

The Centers for Disease Control and Prevention (CDC) estimates that approximately 76 million new cases of food-related illness – resulting in 5,000 deaths and 325,000 hospitalizations – occur in the United States each year.

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Will Dietary Supplements Get Oversight?

Government oversight of dietary supplements is moving closer because of an agreement among senators to include guidelines in a food safety bill,known as the FDA Food Safety Modernization Bill.

Those provisions include:

--Requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services;

--Riving the Food and Drug Administration authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded or "the use of such supplement could cause serious adverse health consequences such as death;"

--Requiring the FDA commissioner to publish guidelines on new dietary ingredients "as soon as possible;"

--Mandating that the FDA notify the Drug Enforcement Administration when a new product contains a synthetic anabolic steroid.

Find it here: http://www.govtrack.us/congress/bill.xpd?bill=s111-510

It has a way to go, but this is a baby step in the right direction.

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Boston Scientific: Medical device maker suspends sale of two product

Boston ScientificImage via Wikipedia

Boston Scientific Corp. discovered a documentation error in its regulatory filings “in the last few days” that led the company to halt sales of its cardiac defibrillators.

The two devices that the Natick, Mass.-based company have temporarily shelved are its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators

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MDL News: Panel meets in San Diego March 25

San Diego PanoramaImage by John in LA via Flickr

The United States Judicial Panel on Multidistrict Litigation, known informally as the MDL Panel, meets next week in San Diego.

The JPML's site now lists the locations of the upcoming MDL hearings. They are:

May 27, 2010 -- Everett McKinley Dirksen United States Courthouse, Chicago, IL
July 29, 2010 -- James A. McClure Federal Building & Cthouse, Boise, Idaho
September 30, 2010 -- Vanderbilt University Law School, Nashville, Tennessee
November 18, 2010 -- Duke Law School, Durham, North Carolina

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FDA: Beware of Fake Surgical Mesh

The FDA cautioned healthcare professionals and consumers about counterfeit surgical mesh products marketed as a known brand of the soft tissue support product.

The fake mesh is marketed under the C. R. Bard/Davol name, with a number of fake lot numbers on the label.

The FDA has not received any adverse event reports from doctors or patients who have used the counterfeit, but the agency cautioned healthcare professionals that the strength, sterility, and clinical performance of the fake have not been evaluated and may be suspect, the agency said in a statement.

The FDA said it's trying to find out who's running the counterfeiting operation.

The real C. R. Bard/Davol and the FDA identified products with these lot numbers as fakes:

* Bard Flat Mesh 2" x 4" Lot 48HVS036 and 43APD007
* Bard Flat Mesh 10" x 14" Lot HUSD0629 and HURL0336
* Bard Flat Mesh 3" x 6" Lot 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSEF0763, 43IOD011, and 43IPD038
* Bard Flat Mesh 6" x 6" Lot 43FQD327

Source here.

Georgia: State Supreme Court Uphold ER Gross Negligence Statute

In a 4-3 decision, the Georgia Supreme Court has issued an ruling on a challenge brought by a woman who went to an ER complaining of serious eye pain She said a doctor sent her away with a prescription and failed to diagnose her real, disabling illness.

Georgia passed a statute in 2005 that stated a a plaintiff must establish by "clear and convincing evidence" that an ER doctor committed "gross negligence" to prevail in a lawsuit.

Find the opinion here.

Sunday, March 14, 2010

CA County Sues GSK over Avandia

AvandiaImage by neofedex via Flickr

A Northern California county has filed suit against GlaxoSmithKline accusing the pharmaceutical company of suppressing evidence that its diabetes drug Avandia causes increased risk of heart attacks.

The lawsuit filed by Santa Clara County seeks restitution for all Avandia purchasers in California claiming the company violated state false-advertising statutes.

"GSK's unlawful conduct has cost patients, their insurers, and government payors millions of dollars, and it has caused needless suffering to thousands of Californians," said Santa Clara County's acting county counsel Miguel Marquez. "This is precisely the sort of corporate malfeasance that California law prohibits."

Here's the source.

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Fosrenol Maker Gets an FDA Warning Letter

FDA introduces an open governmentImage by Ari Herzog via Flickr

Shire , maker of a treatment for end-stage kidney failure, received an unusual warning from the FDA over its mismarketing of the drug Fosrenol.

The FDA said the company made several no-no's, which were:

* It left out the risk warnings, which include Crohn’s disease and bowel obstruction.
* It said Fosrenol was safer and more effective than other drugs, when the FDA believes there’s not enough evidence for that.
* It said Fosrenol could prevent “bone disease, heart disease or death,” when there’s no evidence for that.
* And it said Shire broadened the approved uses of the drug outside end-stage renal failure.

Source: http://industry.bnet.com/pharma/10007126/fda-issues-rare-quadruple-warning-to-kidney-drug-maker-next-up-double-secret-probation/

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FDA : New Boxed Warning for WinRho SDF

Rho(D) immune globulin intravenous (WinRho SDF) get a black box warning about the risks of treating patients with immune thrombocytopenic purpura (ITP) after reports of some patients dying from intravascular hemolysis (IVH), per the FDA.

Some ITP patients treated with the immunoglobulin have developed IVH, which can lead to clinically compromising anemia and multisystem organ failure, including acute respiratory distress syndrome, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program.

Other serious complications reported after administration of WinRho SDF are severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, according to the FDA.

Source: http://www.medscape.com/viewarticle/718311

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

Marketed under the brand names Procrit, Epogen and Aranesp, each can now be prescribed and dispensed only after hospitals and physicians prescribing them have certified that patients have been apprised of the drugs' risks.

New studies have found that cancer patients and others taking this class of medications have had higher rates of tumor growth and of heart attack, heart failure, stroke or bloodclots than patients who are not on the medication. Compared with patients not on medication, patients taking the erythropoeisis-stimulating agents (or ESAs) overall have been found to die sooner as well.

Source here at the FDA site.

FL: Courts Seek More Judges

Florida Supreme Court Building, Tallahassee, F...Image via Wikipedia

The Florida Supreme Court released its annual certification opinion on February 25. It called for 53 more county judges and 37 more circuit judges, citing rising caseloads around the state. The justices said the court system desperately needs the restoration of the 10 percent of its budget that was cut over the past three years, leading to 290.5 job cuts among supporting staff.

“The budget reductions and loss of positions sustained by the State Courts System over the last two fiscal years continue to be felt in every judicial circuit,” Chief Justice Peggy Quince wrote for a unanimous court. “We cannot overstate the causal relationship between the loss of supplemental resources and the increases in case processing times. When judges must absorb the workload of case managers, staff attorneys, or hearing officers, case processing times inevitably worsen. The net result is court delay.”

In county courts, the loss of traffic court hearing officers means that county judges have to handle nearly an extra 500,000 civil traffic cases a year.

Read more at the source, the Florida Bar News.

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Saturday, March 13, 2010

In FL: Public doesn't have right to speak at public meetings

Town Meeting ConferenceImage by Mark Sardella via Flickr

Government meetings have to be open to the public, but that doesn't mean citizens have a right to speak at them, a Florida appeals court ruled.

"Appellants have failed to point to any case construing the phrase 'open to the public' to grant the public the right to speak."

The 1st District Court of Appeal cited previous Florida Supreme Court rulings that The public has no authority to participate in or to interfere with the decision-making process.

Pensacola activists filed suit against Community Maritime Park Associates, saying the board's decisions about a $40 million museum and waterfront park should be nullified because public-comment periods at its meetings were inadequate.

Here's the PDF of the opinion.

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N.J. Court: Libel claim versus Gmail user: Emailer Can Remain Anonymous

Image representing Gmail as depicted in CrunchBaseImage via CrunchBase

Upholding the right to send anonymous emails, a New Jersey appellate court has rejected a request to unmask a Gmail user who accused a student of underage drinking.

The court ruled that although high school student Alexandra Zubowski alleged she was libeled in the email, she didn't submit an affidavit stating the email's content was false. Without such a document, she had not presented a solid enough case of defamation to be able to unmask the sender, the court ruled.

Worth a read here: http://www.mediapost.com/publications/?fa=Articles.showArticle&art_aid=124213

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Baby Sling Safety Warning

The Consumer Product Safety Commission is investigating at least 14 deaths involving baby slings. Safety officials warned parents of the potential danger of carrying infants in them. From CBS:

Weekend Tech This n' That

Second generation iPod Touch.Image via Wikipedia

Trying some new apps on the iPhone, including:

Conference Calll:
Ifbyphone’s Conference Call application enables you to schedule outbound conference calls right on your iPhone or iPod Touch. You're scheduling outbound phone calls to contacts, rather than waiting for them to dial in. You just select contacts and schedule a time. Selected contacts will receive a call and, upon answering, they will be connected to the conference call.

Find it here.

Scan2PDF Mobile: Uses the iPhone to scan documents and convert them to PDF files. It all happens on your phone allowing you to scan documents anywhere - as long as you have your phone.

The software enhances and compresses the output from the camera into a high-quality PDF which is then stored on your phone and can be emailed. Scan2PDF Mobile is compatible with almost all Windows Mobile phones as long as they have a built-in camera with a resolution of at least 1 mega-pixel.



scanR Business Center lets you scan, print, and fax from your iPhone 3Gs; it's like a scanner in your phone. Stop hunting around for that misplaced document, article, or invoice; instead save them instantly as searchable Adobe PDF files you can search from your computer, browser, or right on your iPhone.

Key Features:

• scan documents or whiteboards with your camera and turn the photos into clean, searchable Genuine Adobe PDF files
• print scans from your iPhone to any nearby fax machine
• streaming view for your files – quickly download what you need to see
• fax around the world directly from the iPhone
• share any file anywhere
• online storage gives access to any of your scans and faxes via web browser or iPhone



Windows/Mac/Linux: If you would like to easily access, edit, and save files across multiple computers, free application FeelHome allows you to share files across operating systems and over the web.

Once you install FeelHome on your computer and specify which folders you want to share, you can access those files from the web or from another computer in your virtual FeelHome network.


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FDA: Insulin Pump and User Error

Diabetics who wear insulin pumps appear more likely to experience problems from improper use than a device defect, members of a U.S. government advisory panel said on Friday.

The Food and Drug Administration said problems with insulin pumps have occurred across the industry and asked the panel of outside experts for ways to minimize risks from malfunctions. Makers of the pumps include Medtronic, Roche, and Johnson & Johnson.

About 375,000 adults with type 1 diabetes used the pumps in 2007, up from 130,000 in 2002, the FDA said.


Glaxo: Poligrip with Zinc? Not Anymore

The maker of Poligrip denture cream will stop making formulas containing zinc, doing so while there are pending lawsuits alleging that years of excessive use caused neurological damage and blood problems in consumers.

Glaxo's voluntary action comes as the cases are moving through the lawsuit phase, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in hands and feet, and leaving some patients paralyzed.

Even though zinc is a very essential requirement for a healthy body, excess zinc can be harmful, and cause zinc toxicity. Excessive absorption of zinc can also suppress copper and iron absorption. The free zinc ion in solution is highly toxic to plants, invertebrates, and even vertebrate fish. The Free Ion Activity Model (FIAM) is well-established in the literature, and shows that just micromolar amounts of the free ion kills some organisms. Source.

Source here.

Friday, March 12, 2010

Georgia: Plavix Gets a Blackbox Waring

The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.

A black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.

The new label for Plavix warns that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.

Such patients are so-called "poor metabolizers" who carry a variant CYP2C19 gene affecting the enzyme that converts Plavix into its active form.

A less strident warning about poor metabolizers first appeared on the Plavix labels in May 2009. Based on new information from a drugmaker-funded study and other research, the FDA has now strengthened the warning.

HealthDay News had said in 2009 that patients taking the clot-preventing Plavix following stent implantation should stay away from PPIs, or proton pump inhibitors. Stents are implanted in artery-opening cardiac surgeries and PPIs, said HealthDay News, include drugs such as Nexium, Prevacid, and Prilosec.

Data on nearly 17,000 Plavix users—who took the drug for over one year following stent implantation—were analyzed, said HealthDay News, citing Eric J. Stanek, senior director of research at drug distributor Medco Health Solutions. The team found that the incidence of cardiovascular events was 51 percent greater in patients taking the Plavix-PPI combination over those on Plavix alone, said Stanek, according to HealthDay News. "Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment," Stanek said.

Talk to your doctor before you make any decisions regarding medications you are taking.


As far back as November 23, 1998 the Federal Drug Administration (FDA) expressed its concern with the claims made by the drug manufacturer, Bristol-Myers Squibb/Sanofi Pharmaceuticals about Plavix. A number of patients were instructed (as recommended by the manufacturer) to take Plavix along with aspirin.

A study published by the New England Journal of Medicine states that although doctors believed the combination of Plavix and aspirin would reduce the risk of a second heart attack, the study actually found that the combination not only does not help, but doubles the risk of death, heart attack or stroke in people with no history of heart disease. It was also found to be associated with increased risk for moderate and serious bleeding. To further cite the New England Journal of Medicine, the cost and risk of Plavix do not justify its use for the prevention of coronary artery disease and heart attack.

Thursday, March 11, 2010

Recalls From Salmonella May Rise to 10,000 Products

Yes, you read the right - 10,000 products. Some folks forget that the F in FDA stands for Food and Drug Admin. Some say that better represents the letter grade the agency should gets for doing its job.

They include: McCormick, the seller of spices and herbs, expanded a March 5 recall today to include additional “best by” dates of the four products, which include a French onion dip mix.

PepsiCo said yesterday in a statement that it voluntarily recalled its Quaker Baked Cheddar Snack Mix. HVP is a “very minor” ingredient in the seasoning of the snack, which was recalled “out of an abundance of caution,” the Purchase, New York-based company said.

On March 8, a North American unit of Nestle said it was recalling about 6,000 pounds (2,722 kilograms) of a ready-to-eat bacon base product. The same day, Cincinnati-based P&G recalled the two flavors of Pringles.

Wal-Mart’s Great Value Ranch Chip Dip, manufactured for the world’s largest retailer by the T. Marzetti Co. of Columbus, Ohio, has been pulled from the shelves, according to Wal-Mart spokeswoman Anna Taylor.

Kroger, Safeway

Store brand products at drugstore chain CVS Caremark Corporation, and grocery-store chains Kroger Co. and Safeway Inc. have also been recalled, according to the FDA’s site.

No Illnesses

To date, there are no known illnesses associated with the contaminated HVP, which is sometimes referred to as a “natural flavor” on ingredient labels. The FDA has said the overall risk to consumers is low because most products containing HVP are cooked during processing or are cooked by consumers, which would eliminate any salmonella. In uncooked, ready-to-eat products, like chips and dips, the risk is greater.

Wednesday, March 10, 2010

One Government Agency rips another: GAO says FDA Needs to Pay Attention

In an article sure to give you the thought, "Well duh" there is this news:

Congressional investigators say the Food and Drug Administration should pay more attention to the safety of some food ingredients, including one involved in a widespread recall this week.

A report released Friday by the Government Accountability Office points out that some spices, artificial flavors and other ingredients are not subject to frequent safety reviews by the FDA because the agency or manufacturers deem them "generally recognized as safe." A flavor-enhancing hydrolyzed vegetable protein recalled Thursday due to salmonella contamination is among those ingredients.

The investigators said the FDA has not done enough to review the substances and recommends the agency require companies making or using them to provide the government with more information.

Other substances "generally recognized as safe" include salt, trans fats found in partially hydrogenated vegetable oils, spices, artificial flavors, emulsifiers, binders, vitamins, minerals and preservatives intended to enhance a food's taste, texture, nutritional content or shelf life, according to the report, which notes increasing public concern about salt and trans fat.

The FDA can't keep up with approved drug products, or timely act to ask to have unsafe drugs removed from the market, yet somehow it will keep up with unsafe spices and proteins? Congress needs about 16 billion more in the FDA's budget to get it to be in the woefully underfunded stage.


Thomas Medical Products Recalls Sheath Introducer Kits

Thomas Medical Products has announced a class I recall for its Transseptal Sheath Introducer Kit, citing concerns about increased risk for device breakage.

The recall was initiated on Feb. 1, 2010 and applies to all devices manufactured and distributed from Oct. 1, 2006 to Dec. 27, 2009. The products included in the recall can also be identified under the trade names HeartSpan, CHANNEL FX, Torflex and Braided Guiding Introducer Kit.

Source here.

FDA Says Basic Food Flavors Kept Up Production after learning of Contamination Detected in HVP

From the source below:

FDA said that the company mangers had received the samples that tested positive for salmonella on January 21st.

Basic Food Flavors is known for producing hydrolyzed vegetable protein, which essentially enhances the flavor in processed food items. It is available in the form of a powder which is supposed to be mixed with the food.

The FDA was first informed about the contamination problem by a food manufacturer in February, following which the inspectors visited the plant. They reported of the dirty utensils and equipments and some other problems that are home to bacteria breeding.

“In one area where paste mixers and belt dryers were positioned in the drain near the area, the hydrolyzed vegetable protein was turned from paste to powder. We sensed an odor in the vicinity of this drain", reported the inspectors.

Source here.http://topnews.us/content/212883-fda-claims-basic-food-flavors-continued-production-despite-contamination-detected-hvp

Tuesday, March 09, 2010

FDA Recalls Foods with Flavor Enhcnacers b/c of Salmonella

Federal health authorities announced the recall of a commonly used flavor enhancer after samples of the product were found to contain salmonella.

It may be in the thousands according to the director at the Office of Food Safety at the Food and Drug Administration's Center for Food Safety and Applied Nutrition, about the product, called hydrolyzed vegetable protein, also called HVP.

The bacterium, identified as Salmonella Tennessee, was found in HVP manufactured by Basic Food Flavors Inc. of Las Vegas, Nevada.

HVP is used in processed foods, including soups, sauces, chilis, stews, hot dogs, gravy, seasoned snack foods and dressings.

"We are working hard to respond to this particular outbreak; we also are working hard to put in place the kinds of preventive control measures to prevent this kind of contamination from happening in the first place," said FDA Commissioner Dr. Margaret A. Hamburg.

Source: Here.

Sunday, March 07, 2010

A Video that's a Must See (GA, Nestlehutt Malpractice Case)

WE THE PEOPLE from Georgia Justice on Vimeo.

This is a video that discussed Atlanta Oculoplastic Surgery v. Nestlehutt, which challenges the provisions of Senate Bill 3, passed in 2005 by the Georgia General Assembly, that caps noneconomic damages that a jury may award to a victim of medical malpractice at $350,000.00.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

In the Nestlehutt case, a Fulton County, Georgia jury awarded Mrs. Nestlehutt well over $350,000.00 for permament injuries she received to her body due to medical malpractice by her physicians. After a trial, the Fulton County jury found Mrs. Nestlehutt's case to be meritorious and awarded her substantially more than the $350,000.00 cap. When judgment was about to be entered, however, the Fulton County trial court judge ruled that the cap of $350,000.00 found in SB3 was unconstitutional.

Expect a decision on this case soon.

Saturday, March 06, 2010

Insulin Pump Dangers? (Alabama/Georgia)

From lawyer Rob Bunch:

The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson.

According to the FDA panel papers, here are"Device Problems:"

The most frequently reported device problem in MDR’s related to insulin infusion pumps was ‘unknown,’ and the top five reporters identified “unknown” in 5421 of 16640 reports (19.7% of reports). The second most frequent device problem reported was “replace,” which accounted for 2385 entries (9% of reports).

Patient Problems included:
Patient Problems
The most frequently reported patient problems were 1) hospitalization, and 2) blood glucose high. Of the 16640 MDRs from the top five manufacturers, hospitalization was identified in 7967 reports (21% of reports) while blood glucose was identified in 6236 reports (16.6% of reports). The other most frequently reported patient problems reported were:
 Diabetic Ketoacidosis (8% of reports)
 Hyperglycemia (8% of reports)
 Treatment with medication (6% of reports)
 Blood glucose low (4.7% of reports)
 Therapy/non‐surgical treatment (4% of reports)

Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.

The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.


MiniMed Insulin Pumps
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.

Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.

Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.


Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.

Insulin Overdose Symptoms
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:

* Severe headache
* Increased/rapid heartbeat
* Nausea
* Tremors, anxiety
* Uncontrolled sweating
* Hypoglycemia

One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Symptoms include: cold sweats, confusion, double vision, convulsions, fatigue and general discomfort. Severe hypoglycemia can result in seizures, coma and death.

Call us today if you believe that an improperly functioning insulin pump has harmed you. Call Rob Bunch today. 256-764-0095

Thursday, March 04, 2010

FDA to Beverage Companies: Watch How you Tout

Bottle of POM Wonderful brand pomegranate juiceImage via Wikipedia

The U.S. Food and Drug Administration recently sent letters to 16 firms – including five RTD beverage companies – citing ingredient and health claim violations.

The agency’s letter to POM Wonderful said POMs expansive health claims – including boasts that it may help with blood pressure, prostate cancer and erectile function – elevate POM to the level of unapproved drug rather than a food product.

POM’s label lists its nutrition content, the FDA said, by omitting the name of its antioxidant. The label also boasts a high level of “phytochemicals,” which are not eligible for a nutrition panel call-out because the FDA has not established a recommended daily intake for the substance.

The agency slapped Nestle’s Juicy Juice with a warning in December for violating regulations specific to children’s foods and beverages. Its “no sugar added” claim is not authorized for products intended for children under the age of 2, the FDA said. First Juice received a similar warning this month, but the FDA went further with Nestle, calling the labels on the offending products “misleading.” Juicy Juice’s Orange Tangerine and Grape products both claim, in bold letters, to be 100 percent juice, but clarify in smaller letters that they are not 100 percent Orange Tangerine or Grape juice.

Source: http://www.bevnet.com/news/2010/3-4-2010-FDA_warns_beverage_firms_on_health_claims

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Georgia: Yaz and Yasmine Injury Lawsuits

New Jersey state courts have designed claims relating to Yaz as a mass tort, and will be centralized under one judge for coordinated handling.

New Jersey’s Administrative Office of the Courts ordered on February 18 that the litigation will be assigned to Judge Brian R. Martinotti in Bergen County Superior Court. All pending and future New Jersey state court Yaz lawsuits, Yasmin lawsuits and Ocella lawsuits filed over Bayer’s popular birth control pills will be handled by Judge Martinotti, who will oversee the case management and trial issues.

Bayer Healthcare Corp. stated its oral contraceptives Yasmin and Yaz contained possible side effects, the pills' maker said in response to lawsuits.

More than 50 women in Indianapolis have filed suit against the company, joining dozens of women nationwide who allege the birth control pills caused heart attacks, strokes, blood clots and other health problems, The Indianapolis Star reported Monday.

Yasmin and Yaz contain drospirenone, which the lawsuits allege can lead to dangerously high levels of potassium.

Bayer officials said the contraceptives are safe when used properly and that all packages of oral contraceptives, including Yasmin and Yaz, carry warnings of possible side effects.

UPI is the source.

Baxter: Dialysis Machine Recalled

The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.

The FDA classified the action as a Class 1 medical device recall, meaning that the defective product has the likely potential of causing serious injury or death.

It has been confirmed that at least one death and several serious injuries have occurred among users of the dialysis machines that overfilled their abdominal cavities, causing a condition known as Increased Intraperitoneal Volume (IIPV).

Dialysis is used to replace kidney function in patients suffering from kidney failure. Peritoneal dialysis machines, like the Baxter HomeChoice and Home Choice Pro devices, pumps a sterile glucose solution into the abdominal cavity around the intestines, which absorbs waste products from the blood through osmosis before being drained out of the body. Peritoneal dialysis is known for its ability to be used at home by patients without assistance.

IIPV can cause a number of problems and potentially fatal injuries, including abdominal wall or diaphragmatic hernias, heart failure, acute hypertension, pulmonary edema, hydrothorax, decreased pulmonary function, pericardial effusion, and peritonitis. Children and non-verbal patients are considered to be most at risk. Children’s abdominal cavities are smaller and can be injured faster by IIPV than an adult, and non-verbal patients and children may not be able to adequately communicate that there is a problem.

According to a Baxter press release, signs of IIPV can include:

* Difficulty breathing
* Vomitting
* Feeling full or bloated
* Abdominal pain or discomfort
* Swelling of the genitals, belly button or groin
* Leakage of fluid from the peritoneal dialysis catheter
* Unexpected increase in blood pressure
* Children crying during therapy without apparent reason

The recall affects all Baxter HomeChoice Automated Peritonela Dialysis Systems with the product codes 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, and 5C4474DR. The recall also affects Baxter HomeChoice PRO Automated Peritoneal Dialysis Systems with the product codes 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300 and T5C8300R. Both systems have been distributed to patients since 1994.

The FDA warned that patients and caregivers should watch for any signs of IIPV. If any signs of IIPV are noticed, the device should be stopped immediately and a manual drain initiated. Then a doctor should be contacted immediately.

More information here: http://www.baxter.com/press_room/press_releases/2010/03_02_10_homechoice.html