Feds/States Launch Avandia Investigations

The maker of Avandia -- GSK --- has received from the Department of Justice more than one subpoena. Several U.S. states are also considering action against the company, and new claims from patients hit the courts regularly.

Avandia, the once-top-selling diabetes drug, has been plagued by safety concerns since 2007. After several years of weighing data and more data, regulators in Europe chose to pull the drug off the market completely, while FDA put severe restrictions on its use. The company won't market the drug anymore, either. GSK wrote off supplies of the drug--$233 million worth--because they'll never see the light of day.
Justice's subpoena involves GSK's development and marketing of Avandia, the company says; as the Wall Street Journal notes, it's unclear whether the probe is criminal or civil. No doubt the feds will be looking into allegations the company kept safety concerns about the drug under wraps. GSK maintains that it handled Avandia worries appropriately.

The company said it has also received "civil investigative demands" from states attorneys general about Avandia's development and marketing. Then there are the patient suits; GSK says it doesn't yet know whether it needs to set aside more money to cover eventual liabilities from the drug. This legal battle has only just begun.


Read more: GSK: Feds, states launch Avandia probes - FiercePharma http://www.fiercepharma.com/story/gsk-feds-states-launch-avandia-probes/2010-10-22#ixzz13UhiHEY8
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Scary News: Halloween Lollipops/Raisinets Recalled

Image by cthoyes via FlickrMore Halloween candy has been recalled as the FDA announces the recall of Mega Pops lollipops. The lollipops may contain traces of foreign particles although the manufacturer, Colombina SA, claims there is no health risk.
The product is distributed in retail stores across the United States, including Family Dollar stores here in Rhode Island. The product comes in 14 oz and 28 oz cellophane bags in watermelon, cherry, orange and grape flavored pops.
Also:
 
The FDA has issued a nationwide recall for Raisinets Fun Size 10 oz bags of candy as some may contain undeclared peanuts. The Nestle Raisinets are in fun sized packages that may have been purchased by consumers for Halloween at Target, Shop Rite and Don Quixote retail stores in the US.

If a person eats the product who is allergic to peanuts, they may have a serious or life-threatening allergic reaction.Three complaints have been received to date, although there is a statement on the package that reads, "equipment that also processes peanuts," Nestle indicates that the product may actually contain peanuts.

Recalled Raisinets product code and UPC number

The only product involved is Nestlé Raisinets Fun Size Bags (10oz) with a production code of 02015748/UPC number 2800010255. No other Nestlé products are impacted.

Source: http://www.examiner.com/product-recall-in-national/raisinets-recall-lot-numbers-nestle-recalls-raisinets-candy

Fentanyl Patches Recalled

Image via WikipediaActavis Inc. is recalling 18 lots of its Fentanyl Transdermal System 25-mcg/hour C-II patches because the opioid-containing products may release their active ingredient faster than approved specifications permit.

From the FDA site:
 

ISSUE: FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

BACKGROUND: Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. The product is manufactured for Actavis by Corium International in the United States.

RECOMMENDATION: Wholesalers and retailers are being asked to return the product they have on hand or in stock. See the Press Release for recalled product lots. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Testing for Rx Drugs in the Workplace

Image via Wikipedia
I found a good article on the challenges of drug testing and what employers face.


Twenty years  after the U.S. Supreme Court upheld the right to test for drugs in the workplace. In 1986, the U.S. Customs Service imposed a drug testing program for "employees seeking transfer or promotion to positions having direct involvement in drug interdiction," required to carry firearms, or have access to classified information. The National Treasury Employees Union sued and alleged that the program was violative of the Fourth Amendment, which prohibits unreasonable search and seizure. The Court of Appeals for the Fifth Circuit ruled in favor of the government.

The union then appealed to the Supreme Court. The Supreme Court upheld the Court of Appeals ruling with regard to positions involving drug interdiction and firearms. The ruling for classified information was held over, as the Supreme Court determined that the U.S. Customs Service too broadly included employee groups who would not generally have access to high levels of classified information.

Now, employees who take certain medications that may pose a safety hazard  are a concern. The growing reliance of Americans on powerful prescription drugs for pain, anxiety and other illnesses suggests that many are reporting to work with drugs in their systems, and employers are "grappling for ways to address that."


 There is a dearth of data from independent groups regarding impairment from prescription drugs in the workplace, partly because the issue has not drawn broad scrutiny. But Quest Diagnostics, a prominent provider of workplace drug tests, said that the rate of employees testing positive for prescription opiates rose by more than 40 percent between 2005 and 2009, and by 18 percent last year alone. The data, culled from the results of more than 500,000 drug tests, also indicated that workers who were tested for drugs after accidents were four times more likely to have opiates in their systems than those tested before being hired.

Read more here. 

CareFusion Pump Recall

Image via Wikipedia The FDA has issued a ecall of 17,000 electronic infusion pumps made by CareFusion, saying a flaw in the devices could case serious injury or death in certain situations.

The San Diego medical device maker sent out urgent notification letters in August  to customers using model 8015 of the Alaris PC unit made between December 2008 and September 2009. The machines are mainly used by hospitals to deliver medications and other fluids to patients intravenously.

Certain wireless network conditions can cause the device to suffer intermittent communication errors that freeze the unit’s screen, the company said. The problem can cause the unit to shut down if a nurse attempts to modify drug delivery instructions.

CareFusion promised to fix all of the units. In the interim, the company provided customers with warning tags to attach to defective machines and gave them instructions on disabling the device’s wireless operation.
The company said it had put aside enough money in the fourth quarter, which ended June 30, to cover the costs of the recall.

High Levels of Peroxide found in Crospovidone

The FDA agency announced findings in an advisory last week, warning pharmaceutical manufacturers the higher than permitted peroxide concentration, which was four times the level allowed by global compendial monographs, may reduce drug efficacy.

There are no of illness or accusations of wrongdoing as to the Crospovidone batch.

Supplier reliability review

The FDA has said  “Users and distributors implement robust supplier management programmes,” suggesting that reviewing supplier reliability is critical.

It also said drugmakers should analyse samples for peroxide levels, explaining that while no test is listed in Crospovidone monograph the a non-specific USP/EP method can be used to detect levels in excess of 400 ppm.

Source. 

Teething Tablets Recalled

A California company is working with the FDA and voluntarily recalling  teething tablets for infants and toddlers. They are made by Standard Homeopathic Company and are sold as Hyland's Teething Tablets and are sold in bottles of 50 to 250 tablets.  Adverse problems have been reported but the F-D-A says a conclusive link has not been determined.  Consumers who are concerned about the safety of the product can contact the company for instructions on a refund or replacement product.
          
 The Hyland's Teething Tablets UPC codes included in the recall are:

1. Hyland's Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland's Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland's Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland's Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland's Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland's Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109



Source

ALLSTATE AGREES TO $10 MILLION REGULATORY SETTLEMENT OVER BODILY INJURY CLAIMS HANDLING PROCESSES

Image via WikipediaFrom the GTLA Blog:

Allstate has agreed to pay New York $1.2 million as part of a $10 million regulatory settlement, New York State Insurance Superintendent James J. Wrynn announced today. The agreement follows an 18-month targeted National Association of Insurance Commissioners (NAIC) multi-state market conduct examination of Allstate’s claims handling practices.
“Allstate has agreed to implement procedures to ensure transparency and fairness for consumers who have bodily injury claims,” Wrynn said. “The new processes ensure that claims will be handled consistently in different regions of the country, and consumers will have the right to get the information they need in order to understand how Allstate evaluates their claims and make sure they are fairly treated.”

The NAIC examination, for which New York was one of the lead states, focused primarily on Allstate’s use of claims handling software, particularly the software program, Colossus.

Colossus is a software program Allstate used to guide its settlement offers for bodily injury claims after automobile accidents. The examination found inconsistencies in Allstate’s management and oversight of the Colossus software program. In particular, the examination found that Allstate had failed to modify or “tune” the software in a uniform and consistent manner across its claims handling regions.

Under the settlement agreement, Allstate agreed to make a number of changes to its claims handling process, including:

• Providing notice to claimants that the Colossus software program may be used in the adjustment of their bodily injury claims;
• Enhancing its management oversight of Colossus to ensure that it adheres to established criteria and a uniform methodology in selecting claims to be used to “tune” or modify the software to reflect recently settled claims;
• Strengthening its internal auditing of Colossus and bodily injury claims handling to ensure adherence to written guidelines and procedures;
• Consolidating its bodily injury claims handling practices into a single claims handling manual; and
• Not establishing a policy or rule requiring claims adjusters to settle bodily injury claims solely on the value recommended by Colossus and not providing incentives for claims adjusters to settle claims at or near the value recommended by Colossus.

“It is important to note that we found no systemic underpayment of bodily injury claims,” Wrynn said. “While the issues addressed were serious, Allstate cooperated fully with our examination and is working to correct these deficiencies. Here in New York, we will continue to review the use of claims handling software by property/casualty companies.

“This settlement shows how state insurance regulators work together to protect consumers,” Wrynn said. “The four lead states – Florida, Illinois, Iowa and New York – worked cooperatively to conduct this examination and will keep working with the other 41 states that have signed on to this agreement to ensure it is fully implemented and consumers are properly protected.”
Allstate’s payment will be used to establish a regulatory fund. The fund will be used by the 45 signatory states, to the extent consistent with applicable state laws, to develop and train examiners to review and monitor the property/casualty industry’s use of software technology in adjusting claims

Another Tylenol Recall

Image via WikipediaA moldy odor problem has hit Johnson & Johnson's Tylenol, and the company is recalling another lot of the over-the-counter painkiller.

J&J had recalled millions of bottles of Tylenol and other consumer medicines in the past year because of complaints of a musty or moldy odor in the product, said it was voluntarily recalling another lot.

"This voluntary action is being taken as a precaution and the risk of adverse medical events is remote," the diversified healthcare company said in a release.

A company spokeswoman identified the product as adult Tylenol eight-hour caplets sold in 50-count bottles in the United States and Puerto Rico.

She said the recalled lot was made in March at a factory in Fort Washington, Pennsylvania, operated by J&J's McNeil Consumer Healthcare unit.
J&J shut down the McNeil plant the following month and is upgrading the facility to correct quality control lapses discovered by U.S. Food and Drug Administration inspectors.

The FDA cited thick dust, grime and contaminated ingredients at the Fort Washington plant. J&J plans to reopen the plant next year, and is using other McNeil plants to help offset lost production of the recalled products.

Products made at the plant had annual sales of about $650 million, about 1 percent of total annual company sales. But the spate of recalls has tarnished the reputation of J&J and its consumer brands and forced a shakeup at the McNeil unit.

Source: Here

October Avandia Legal News for Georgia

A good report from American Counsel on Science and Health:

As drugs continue to be taken for longer periods of time, unexpected complications may arise that were absent from short-term clinical trials. New York Times science journalist Gina Kolata reported on what happens when drugs cause problems they were originally developed to prevent, focusing on the risks associated with the now highly restricted diabetes drug Avandia, and bisphosphonates, a class of medicine used to treat osteoporosis. 

After post-market analysis revealed that Avandia is alleged to be associated with an increased risk of heart failure, the drug was temporarily removed from the market in Europe and then restricted by the FDA last month. 

“Diabetic treatment is supposed to reduce the rate of diabetic complications including vascular disease, kidney disease and neuropathy — not merely control blood sugar. Studies that show Avandia may increase the risk of heart failure illustrate a case of when a drug does the opposite of what it’s supposed to.” 

Here is the link: http://www.acsh.org/factsfears/newsID.1961/news_detail.asp

In the Middle East, this news:

The UAE Ministry of Health has ordered all doctors and hospitals to suspend prescribing the diabetes drug Avandia.

According to a circular issued Sunday, health officials have decided to suspend all products containing Rosiglitazone over fears in the United States and Europe over its safety. Bahraini health officials have also banned drugs containing Rosiglitazone, like Avandaryl, Avandamet and Avandia, the Gulf Daily News reports.

Dr Ameen Al Amiri, CEO for medical practice and licensing at the ministry, was reported by the official news agency WAM as saying the drug control directorate had held extensive talks with Avandia’s manufacturers and local distributors.

http://www.arabianbusiness.com/avandia-diabetes-drug-be-banned-over-health-fears-351519.html

http://www.markzamora.com/AvandiaGA/index.html

FDA Advisers Back Anemia Drugs for Kidney Patients

Kidney-failure patients can continue taking a group of widely used anemia drugs, even though a recent study showed they can increase the risk of stroke, says the FDA.
 

A panel of FDA advisers voted 15-1, with one abstention, to maintain use of the drugs for patients with chronic kidney disease who aren't yet in need of dialysis, the Associated Press reported. The FDA is not required to follow the advice of its advisory panels, but typically does so. 

The drugs -- Procrit, Aranesp and Epogen, a class of medications known as erythropoiesis-stimulating agents (ESAs) -- boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers, the AP reported.

More here.http://health.usnews.com/health-news/managing-your-healthcare/cancer/articles/2010/10/19/fda-advisers-back-anemia-drugs-for-kidney-patients.html 

Meridia and Other Rx Diet Drugs and their Risks

Image via WikipediaThe real risks of heart attacks, strokes and other possible long-term side effects still are not completely known, even after Meridia was studied and pulled from the market.

Other prescription diet pills include orlistat (Xenical by prescription, Alli over-the-counter), phentermine (Adipex-P), diethylpropion (Tenuate), and phendimetrazine (Bontril). They can help with short-term weight loss. Orlistat can potentially be taken for a longer period of time. None can be considered entirely safe, some folks say.

Orlistat is probably the safest of the five. It blocks the intestine from absorbing fat. The main side effects are frequent bowel movements, greasy stool and gas. You need to stay on a low fat diet to avoid these side effects. A long-term concern about orlistat is that some claim that a user may not get enough vitamins A, D, E, K and beta carotene. These vitamins need fat in the intestine to be absorbed.

Phentermine, diethylpropion and phendimetrazine decrease appetite for the first few weeks of use. They may be prescribed to jump-start weight loss as part of a lifestyle modification program.

http://www.latimes.com/health/sns-health-ask-harvard-meridia-diet-pills,0,6548317.story

OsmoPrep News

The FDA has issued alerts regarding acute kidney injury associated with the use of OsmoPrep. This type of kidney injury is known as Acute Phosphate Nephropathy. OsmoPrep is a type of oral sodium phosphate products (OSP) and it is used for bowel cleansing prior to colonoscopy or other procedures. In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP.

Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OsmoPrep. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.
ndividuals who appear to have an increased risk of acute phosphate nephropathy following the use of OsmoPrep include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

As a result of new safety information received, FDA ias required the manufacturer of OsmoPrep, Salix Pharmaceuticals, Inc. to add a Boxed Warning to the labeling for this product. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of OsmoPrep outweighs the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of OsmoPrep.

Biosphosphonates get an FDA Warning (Fosamax, Actonel, Boniva)

Image by flap via FlickrThe FDA last week asked that certain drug makers add a  warning to the label of all bisphosphonates, which include Boniva, Actonel, and Fosamax.  Health Canada also announced last week that there is evidence that women taking bisphosphonates could have increased risk of thigh bone fractures. The drugs are currently under “safety review” in Canada.
FDA reps said the risk of  certain fractures were highest in those who took the drugs for five years or more, according to data provided by the American Society for Bone Mineral Research Task Force.
A deterioration of the jaw bone has also been associated with bisphosphonates, though osteoporosis experts emphasize that, for those with the disease, the drugs' benefits still far outweigh the risks. Experts don't know for certain if bones continue to benefit from the medications beyond the five or 10 year mark.

FDA Warns Companies Promoting Chelation Products

The FDA is cracking down against the makers of over-the-counter chelation products which are claimed to  help remove toxic metals from the body. These are often sold over the net. Manufacturers say they are are valid treatment for conditions like autism, heart disease, macular degeneration, and Alzheimer's disease, by linking toxic metals to these conditions. 

On Thursday, the FDA issued eight warning letters to companies marketing chelation products, saying that claims about using such products to treat medical conditions violate federal law. "What we're telling consumers is that any chelation therapy marketed over the counter is suspect," Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, said during a briefing with reporters. 


The FDA has approved some chelation products to be prescribed in cases of heavy metal poisoning, but - here is the key -  none are approved for sale over the counter or on  the Internet.

What you see most often is a chelation product marketed as a dietary supplement, with varying dosages and forms, including capsules, liquid drops, and sprays. If not used properly, or without proper warning, the products could cause dehydration, kidney failure, or death, according to the FDA. The agency says it issued the warnings in response to increased product promotion and availability to consumers. If the companies don't correct the violations detailed in the letters, their products could be seized.

More here.http://health.usnews.com/health-news/managing-your-healthcare/bones-joints-and-muscles/articles/2010/10/15/health-buzz-fda-warns-against-the-use-of-chelators.html  

New CPR Guideline: A Must Read

Image via WikipediaJust saw on ABC Good Morning America, as well as on the web, new guidelines. Learn them: 

The average, untrained person can still save a life by focusing on chest compressions first, say new guidelines from the American Heart Association.

The simplified form of cardiopulmonary resuscitation, or CPR, focuses on giving chest compressions to keep the blood -- and the oxygen in the blood -- flowing to the heart and brain.

The group's advice comes on the heels of studies in the past year trumpeting that a compression-only approach is as good or better than compression plus mouth-to-mouth. It updates guidelines from 2005.

When someone  collapses in cardiac arrest, people often don't start any type of CPR, but chest compressions alone are easy, and anyone can do it.

The American Heart Association recommends that if an adult is unresponsive and not breathing or is having occasional unusual breaths that sound like gasping, any bystander should first call 911 (or whatever the emergency number is in the area) and then begin chest compressions.


If someone else is nearby, send that person in search of an automatic external defibrillator, a device that can shock the heart back into normal rhythm.

Read more at the source: http://health.msn.com/health-topics/first-aid/articlepage.aspx?cp-documentid=100266084

10/12/10 Georgia Meridia Recall Lawyer -Background on the product

Meridia is also known as Sibutramine. Until recently it was marketed and prescribed as an adjunct in the treatment of exogenous obesity along with diet and exercise.
My office is investigating claims of injury because of this recalled product.


Sibutramine is a centrally-acting serotonin-norepinephrine reuptake inhibitor. Serotonin and norepinephrine reuptake inhibitors (SNRIs) are a type of antidepressant medication that increases the levels of both serotonin and norepinephrine by inhibiting their reabsorption (reuptake) into cells in the brain. Although the precise mechanism of action isn't clear, it's thought that these higher levels enhance neurotransmission — the sending of nerve impulses — and so improve and elevate mood. Medications in this group of antidepressants are sometimes called dual reuptake inhibitors.


 
Sibutramine was originally launched and marketed by Knoll Pharmaceuticals and was most recently manufactured and marketed by Abbott Laboratories before its withdrawal from the market.
This product should not be used by people with with:

• Psychiatric conditions 
• Patients with a history of or a predisposition to drug or alcohol abuse
• Patients below 18 and above 65 years of age
• History of peripheral arterial disease
• Hypertension that is not sufficiently controlled (e.g., > 145/90 mmHg), caution in controlled hypertension
• Existing pulmonary hypertension
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
• A history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA)
• Stroke or transient ischemic attack (TIA)
• Hyperthyroidism (overactive thyroid gland)

What are the common side effects?
Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.
Sibutramine may  substantially increase blood pressure and pulse in some patients.
These side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).
Symptoms that require urgent medical attention are seizures, problems urinating, abnormal bruising or bleeding, melena, hematemesis, jaundice, fever and rigors, chest pain, hemiplegia, abnormal vision, dyspnea and edema.

FDA : Recent Recalls

Image via Wikipedia
The folks at the FDA have been busy the past several weeks. Here's a short list of recalls:

Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa):The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. Link.

 

Pfizer Consumer Healthcare Issues Voluntary Recall of One Lot of ThermaCare HeatWraps Menstrual Product  The company said it is taking this precautionary step after finding a potential for a leak of the components contained in the wrap, which could cause skin injury such as irritation or burn. Link

 

Recall of AROM-X Capsules, AROM-X UTT Liquid, AROM-XL Liquid, 4-AD Capsules and Decavol Capsules Marketed as a Dietary Supplements Containing ATD: FDA's states that the ingresidnets 1,4,6 etioallocholan-dione do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.

 

Recall of Reversitol a Product Marketed as a Dietary Supplement Containing ATD: FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products. Link.

 

 

 

 

Meridia Withdrawal News

From the FDA:

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

Talk to us at 404-451-7781

Image via WikipediaGaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase.

Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

Potential adverse events associated with the use of anti-aromatases could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Gaspari has received no serious adverse events in over five years of marketing Novadex XT.

Novedex XT had been sold internationally and domestically, to distributors, wholesalers, retail stores and direct to consumers, but was discontinued by Gaspari Nutrition for domestic sales on October 4th 2010. The product was sold in blue bottles with a black cap, containing sixty (60) capsules.