FDA Warns Not to Feed SimplyThick to Premature Infants

Image via WikipediaDo not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.

This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.

SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff—himself a neonatologist—explains that the thickening agent is added to breast milk and infants’ formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.

 

The Problem

FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.
Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.
At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.
This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.

Symptoms to Watch for

• bloated stomach
• greenish-tinged vomiting
• bloody stools

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm256250.htm

Globe All Wellness, LLC Issues Recall of Dietary Supplement Slim Xtreme™ - Found to Contain an Undeclared Drug Ingredient

From the FDA.gov

May 24, 2011 - Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.
All lots of the following dietary supplement products are being recalled:

Slim Xtreme™ Herbal Slimming Capsule 30 Capsules/Bottle

The products listed above were sold and distributed nationwide via the internet and at the company’s headquarters in Hollywood, Florida. The FDA advises that this product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

No illnesses or injuries have been reported to Globe All Wellness, LLC to date in connection with this product.

With abundance of caution, Globe All Wellness, LLC is voluntarily recalling all lots of SLIM XTREME™ from the market as a precautionary measure.

This recall does not affect the sales and distribution of Globe All Wellness, LLC’s other products such as SLIM XTREME GOLD™ or GELSLIM™.

Globe All Wellness, LLC has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Globe All Wellness, LLC is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

More signs that a diabetes drug is linked to bladder cancer?

 
Between 2004 and 2009, more than half a million adverse reactions among people taking anti-diabetic drugs were added to an official U.S. Food and Drug Administration database. Among those reports were 138 instances of bladder cancer in patients taking at least one of more than 15 different anti-diabetic drugs.
However, more than a fifth of those bladder cancers were in patients taking Actos (pioglitazone), suggesting a "disproportionate risk" in comparison with other anti-diabetics, said study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy.

The article is: "Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting" and may be found here. 

Here is the abstract:

OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.

RESEARCH DESIGN AND METHODS Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).

RESULTS Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22). ROR was indicative of a definite risk for pioglitazone (4.30 [95% CI 2.82–6.52]), and a much weaker risk for gliclazide and acarbose, with very few cases being treated with these two drugs (6 and 4, respectively).

CONCLUSIONS In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies. 

source

Georgia: Amoxilina Recalled by FDA (May 16, 2011)

Image via WikipediaMulti-Mex Distributor Inc., of Tucker, Ga., is recalling dietary supplements whose packaging appears to be an intentional marketing ploy to mimic antibiotics and may be directed at Hispanic buyers, according to the Food and Drug Administration.

The products were distributed to retail stores and distributors in Texas, Georgia, Tennessee, California, Illinois, North Carolina, South Carolina, Colorado and Indiana.

 
The FDA inspected the full range of products from Multi-Mex and recalled all of them, including Amoxilina.

Multi-Mex products are in U.S. stores with names that sounded very similar to names in México, including Bisolbom (Bosilvon), Vermex (Vermox), Neolubrina (Neomelubrina), Pentreximil (Pentrexil), Sinalar (Synalar), Terramocina (Terramicina) and Vitaderogil (Aderogil15).

http://www.brownsvilleherald.com/news/dietary-126527-supplements-company.html

Procrit: Does Drug Worsen Heart Attacks?

Image by gandhiji40 via Flickr People who have been administered via IV the drug erythropoietin alfa after suffering a heart attack could allegedly be at risk for new heart problems and possible greater cardiac damage from the attack if a new study is accurate.

The drug has been prescribed for people who had prior heart attacks patients because certain studies suggested it might reduce the extent of heart attack damage.



Find the report here:
http://jama.ama-assn.org/content/305/18/1863.short

Texas AG's Office: Companies Misleading Latinos with Amoxilina

From Latino Fox News: 

'Companies from Texas and Georgia were misleading mostly Latino consumers by selling a dietary supplement whose name is nearly identical to the Spanish translation of a widely popular antibiotic, Texas authorities said.

Now the Texas attorney general's office is suing the companies, claiming their marketing tactics is deceiving consumers. The suit, filed last week in state district court, says the companies further their marketing ploy by making the packaging similar to that of Amoxicillin.

The antibiotic, Amoxilina, was once available in Mexico without a prescription.'

Read more: http://latino.foxnews.com/latino/health/2011/05/09/texas-ags-office-sues-antibiotics-marketed-latinos/#ixzz1LtSkbon3

Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements

Image via Wikipedia
From the FDA:


Multi-Mex Distributor, Inc., Tucker, GA is recalling dietary supplements that may be labeled as antibiotic drugs.

The products were distributed in the following states: Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis, to the retail store and distributors.

The following products are being recalled:

ITEM	Usos	UPC #
AMOXILINA CAPSULS 500 mg (30 Caps)	Suplemento Dietetico	619114010081
AMOXILINA SUSPENSION (3.4 oz)	Suplemento Dietetico	619114010074
BISOLBOM JARABE ADULTO (4.06 oz)	Suplemento Dietetico	619114010104
BISOLBOM JARABE NIÑO (4.06 oz)	Suplemento Dietetico	619114010198
CALCIO + D LIQUIDO ADULTO (8 oz plastic bottle)	Suplemento Dietetico	619114010388
CALCIO + D LIQUIDO INFANTIL (8 oz plastic bottle)	Suplemento Dietetico	619114010371
M. VERMEX  (6 TABLETS)	Suplemento Dietetico	619114010302
M. VERMEX  (1 TABLET)	Suplemento Dietetico	619114010326
M. VERMEX  (1 oz)	Suplemento Dietetico	619114010319
NEOLUBRINA  JARABE (3.38 oz) Syrup	Suplemento Dietetico	619114010234
NEOLUBRINA TABLETAS 500 mg (10 tablets)	Suplemento Dietetico	619114010241
PENTREXIMIL PLUS 500 mg (30 CAPS)	Suplemento Dietetico	619114010012
PENTREXIMIL PLUS Syrup 3.4 oz	Suplemento Dietetico	619114010050
SINALAR GOTAS NARIZ (0.5oz) Drops	Suplemento Dietetico	619114010067
SINALAR GOTAS OIDOS (0.5oz) Drops	Suplemento Dietetico	619114010036
SINALAR GOTAS OJOS (0.5 oz) Drops	Suplemento Dietetico	619114010029
TERRAMOCINA CAPSULAS 500 mg (30 Caps)	Suplemento Dietetico	619114010296
VITADEROGIL GOTAS INFANTIL (0.5oz) Drops	Suplemento Dietetico	619114010142
VITADEROGIL JARABE ADULTO (5 vials inside)	Suplemento Dietetico	619114010159

Warnings of these dietary supplements made news in Texas on Thursday, April 28th, when four children were taken to a Medical Center due to worsening illnesses after being given dietary supplements the parents may have believed were antibiotics and which were packaged to resemble antibiotics that are readily available as over the counter drugs in Mexico. Giving the dietary supplement delayed legitimate medical treatment. Although the labels were printed in English and Spanish, the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers. It was determined the children had been given a dietary supplement, Amoxilina, which the parents may have believed was the antibiotic Amoxicillin.

Image via WikipediaThe makers of cold and fever medications that contain the painkiller acetaminophen said Wednesday night that they will discontinue infant-drops versions of the products to avoid confusion that might lead to overdoses, the Associated Press reported.


Once production ends, later this year, the companies will sell just one formula for all children under the age of 12. Companies such as Johnson & Johnson currently sell infant versions of the drugs (80 milligrams) that contain half the amount of acetaminophen found in regular children's formulas, the news service said.
Acetaminophen is a widely used drug found in a variety of products that helps to ease pain and reduce fever.


The manufacturers' announcement preceded a U.S. Food and Drug Administration meeting scheduled for later this month, at which time agency advisers will consider whether clearer instructions and safety labeling are needed for products containing acetaminophen that are marketed for children younger than 2 years of age, the news service said.

Source here. 

Four Loko Lawsuit News

Image by Getty Images via @daylifeA New Jersey man who says he suffered permanent heart damage after drinking the alcohol- and caffeine-laced Four Loko beverage is suing its manufacturer.


.
The lawsuit, first reported last week by The Press of Atlantic City, claims that during a visit to Atlantic City in October, Mustica drank 2 1/2 cans of Four Loko and suffered heart arrhythmia.
Each can of Four Loko contains 12 percent alcohol — the equivalent of three cans of beer.
Phusion spokesman Chris Hunter declined to comment Monday to The Star-Ledger of Newark but says the company still believes mixing alcohol and caffeine is safe. Phusion agreed to remove caffeine from the drink in November after complaints from the Food and Drug Administration.

Source here. 

Regenerect Recall News May 4, 2011

Image via WikipediaFrom the FDA

Ethos Environmental, Inc. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the brand name Regenerect with the following Lot Numbers:

Regenerect Lot Numbers:
100521 - blue capsule sold individually in foil packets, expires 5/2012
112850 - clear capsule sold individually in foil packets, expires 11/2013

Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Ethos Environmental, Inc. has distributed Regenerect via sales made over the internet to consumers in the United States of America and Puerto Rico.

Ethos Environmental, Inc. advises any customers in possession of the Regenerect product matching the lot numbers above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (866) 925-9553 (Monday through Friday from 6am to 6pm Pacific Time) for instructions on the return and exchange/refund process.
Ethos Environmental, Inc. is committed to improving its products and avoiding future recall issues by improving testing procedures. Ethos Environmental, in an effort to be abundantly cautious, is issuing a voluntary recall on the two lots, mentioned above, that did not comply with the newly adopted testing protocol of Ethos Environmental. The Company’s testing protocol and test results will be available on the Company’s website for all consumers. Any consumers requesting an exchange of product from the two lots in question will be receiving Regenerect product that has been subjected to the Company’s new testing procedures. Ethos Environmental promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

Synthroid, Levoxyl, Levothroid, Unithroid and a New Study Regarding Fracture Risk?

Some senior citizens could face an increased risk for fractures if they ingest excessive doses of drugs used to treat thyroid problems - so says a new study.


You can find the information here: BMJ online. The article's title is:Levothyroxine dose and risk of fractures in older adults: nested case-control study:

From the abstract:

Main outcome measure Primary outcome was fracture (wrist or forearm, shoulder or upper arm, thoracic spine, lumbar spine and pelvis, hip or femur, or lower leg or ankle) in relation to levothyroxine use (current, recent past, remote). Risk among current users was compared between those prescribed high, medium, and low cumulative levothyroxine doses in the year before fracture. 

Results Of 213 511 prevalent levothyroxine users identified, 22 236 (10.4%) experienced a fracture over a mean 3.8 years of follow-up, 18 108 (88%) of whom were women. Compared with remote levothyroxine use, current use was associated with a significantly higher risk of fracture (adjusted odds ratio 1.88, 95% confidence interval 1.71 to 2.05), despite adjustment for numerous risk factors. Among current users, high and medium cumulative doses (>0.093 mg/day and 0.044-0.093 mg/day) were associated with a significantly increased risk of fracture compared with low cumulative doses (<0.044 mg/day): 3.45 (3.27 to 3.65) and 2.62 (2.50 to 2.76), respectively.

The Myth that "Social Media" is a must for Attorneys (Solo, Small Firm, Big Law)

PT Barnum I rarely write about Social Media. We blog (obviously), have a Twitter account, and post on other blogs - mostly with posts that relate to Georgia law and/or pharmaceutical litigation news. Our office is made up of litigators. We try cases- I am in trial Tuesday of this week for the third time this year.

I regularly read about what marketers and other lawyers say about Social Media. The so called social media are for the most part nothing more than  carnival barkers. What I have just read has me irritated because the post's author is just plain wrong and uninformed.

I read an article titled: Small Firms, Big Lawyers: 7 reasons to Avoid Social Media

From the start the author (Jay Shepherd)  points to a recent report that "had a section about which marketing methods solos and small firms found most effective." Shepherd commented on this report:

"The leading methods were:

• online directories (17.7%);
• word of mouth — which isn’t really a method, but more of a thing that happens (15.5%);
• group-advertising ventures (whatever the hell that is) (13.3%); and
• Yellow Pages (8.9%).

"The takeaway for me from that list is that small-firm lawyers don’t know what they’re doing when it comes to marketing." (emphasis added)

“Word of mouth” means sit back and hope someone tells someone else to hire me, “group-advertising ventures” sounds like some sort of mail-order scam, and I didn’t know they still printed Yellow Pages. ... (Sorry, Yellow Pages advertisers. Oh, wait. You’re not reading this because you’re offline.)"

Jay, you're wrong. First -You obviously don't mind putting down practices  you know nothing about  - 'group-advertising ventures" have been around for years. The ventures may look like the Jim Sokolove model, or Staggerwalt and Associates, or others. Surely you have heard about the Texas group that advertises for IP clients on the web. You knew about those firms, right Jay? Or how www.findlaw.com touts its mass buying power on the web to garner better placement for little ol' small firms like mine.

For our office 'group advertising ventures' in the personal injury area of the law might look like a true 'joint venture' - Anywhere from two to seven  law firms form a group that advertises on the web, radio, tv, or newspapers for a particular type of case . (For example, Katrina levee related property damage claims, or those seeking Dupuy knee work).Our firm gets approached at least 3 times a week by ventures seeking our $$$.  OK, dead horse beaten, on to next mistake.  
   

I don't understand your disdain for word of mouth - maybe you stammer in public, or are too arrogant to mix with 'the common folks.' In the south, word of mouth is proactive.

Word of mouth is speaking at a CLE on any area of the law - like trucking. My good friend and litigator Joe Fried is known simply as The Trucking Lawyer. He will speak at more than 30 CLE seminars this year. Here's his site: http://www.thetruckingattorneys.com. Before you scoff, does your firm have more than $25 million in verdicts like his - in the past 10 months? Clients come to him thanks to word of mouth. Lawyers send him work thanks to word of mouth - where he engages people and talks about his results.
  

Word of mouth is the stock in trade for many smaller town attorneys. Rotary clubs, schools groups, alumni groups, lawyer groups, church groups, bible studies, business chambers - that is where word of mouth works.  In my trial last month - in a tech city that is Atlanta - of 34 potential jurors less than 20% had heard of Twitter, but more than 75% were members of a civic or church group.  

We both agree on the Yellow Pages. If you have received a call from 'the books' you'd know that there is a reason why only 8.9% admitted to paying for placement. In fact, I'd guess that 8.9% of any town's lawyers are on Twitter at all.  

To my amazement, there is still an area not yet at the forefront for lawyers on the web - blogging. It is by far the most successful project my firm has taken on in the past 5 years. Our firm has three separate blogs.

Where is an area with little competition? Specialty sites for niche areas of the law. If you are not familiar with this type of site, go ahead and crap on it, Jay.  For others reading this, take a look at  the lawyers at Water Colorado: http://www.watercolorado.com/water_rights2.shtml or attorneys who handle cattle cases:  http://cattlelawyers.com/default.aspx

Specialty sites should be part of a law firms' tech arsenal long before any Twitter account is set up by an attorney. Web sites now are easy to set up and maintain. If for example, someone needs an immigration attorney in the Vietnamese community, what makes a better first impression - a site focused on that ethnic group, or a site that has a law firm with a .jpg of a gavel, and a nav bar with 22 areas of the law?  Spend 20 hours looking at the competition for the type of work your firm wants - and then set up a site in that area alone.    




Now, on to Twitter: Lawyers who get hornswaggled or even brow beaten into thinking Twitter is a must have should be ashamed of themselves for being so damned gullible. But hey, Jay, lead them to Twitter and away from blogging - hours and hours of time will be wasted on Twitter.

You wrote: "But I can connect to 2,345 people at once on Twitter and tell them about something that’s on my mind or that I think they should read.It would take a lot more time to make all those phone calls or have random acts of lunch." Read this though Jay - 99% of those people don't  really care about your one tweet. It's just noise. 


Here's a thought for attorneys - spend more than an hour a month just updating the firm web page. Learn Google Ad Words. Buy a google ad just for your firm name. Buy a .com that is the same as your office telephone number. Learn the basics of the web - before you get seduced by the allure of Twitter.

Find a listserver somewhere - GTLA has one, the Florida Justice has one - and get active there - post on subjects. Comment, engage.  

Those basics - along with word of mouth - will bring results with hard work and discipline.




 

Alli & Xenical: Calls For Pulling the Drugs from the Market

Image by Newbirth35 via Flickr
The group Public Citizen wants the weight-loss drugs Alli and Xenical be removed from the market because of the growing risk of side effects that include liver damage, pancreatitis and kidney stones.

"These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. Find the info here. 

Pancreatitis is inflammation of the pancreas that can occur in two very different forms. Acute pancreatitis is sudden while chronic pancreatitis "is characterized by recurring or persistent abdominal pain with or without steatorrhea or diabetes mellitus

Hepatotoxicity (from hepatic toxicity) implies chemical-driven liver damage.
The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure the organ. Other chemical agents, such as those used in laboratories and industries, natural chemicals (e.g. microcystins) and herbal remedies can also induce hepatotoxicity.

Source for both:  Wiki

FDA to reveiw Trilipix Study

A study of Abbott Laboratories' Trilipix appears to show that women who took the drug in combination with a statin experienced more heart problems than those who just took a statin.

The FDA will meet on May 19th to address the findings of the ACCORD Lipid Study.

Here are the side effects for this drug:

Trilipix Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trilipix Delayed-Release Capsules:

Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; sore throat; stomach upset; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Trilipix Delayed-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; decrease in amount of urine produced; fever, chills, or persistent sore throat; loss of appetite; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Read more: http://www.chicagobusiness.com/article/20110425/NEWS03/110429925/abbott-drug-statin-combo-can-cause-heart-problems-fda#ixzz1KieuN1nT

Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia

The FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

What the FDA suggests:

• Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
• Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.

Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Co

ISSUE: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.

BACKGROUND: The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.

RECOMMENDATION: On March 4, 2011, Penumbra, Inc. notified their customers and distributors of the recall and instructed to return the product to the company.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251402.htm

GAO Rips FDA

From a recent study:

A damning report on the many shortcomings on the creaky old house that is the FDA. It's a grossly underfunded, undermanned, and mess of an agency. It's decades away from repair, and this report shows that perhaps it's time to dismantle it and start anew: 

Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.

and this:

Although FDA’s recall data system contains numerous data elements that would allow for analyses of recall data, our preliminary findings suggest that FDA is not using this system to effectively monitor and manage its recall program.

When it came to recalls that were audited:

Our analysis of 2,196 audit check forms associated with the class I recalls we reviewed found a variety of inconsistencies in how the audit checks were implemented and documented for nearly 90 percent of these recalls. For each of these recalls we found inconsistencies in how different investigators determined whether a recall was effective or ineffective when conducting their audit checks of recalls.

To citizens, the FDA is as useful as FEMA was during Katrina. 

Should Xenical be Recalled?

Public Citizen Director Dr. Sidney Wolfe urges patients not to wait for the FDA to remove the drugs from the market and says to stop taking them immediately. "Unlike other drugs, which have a withdrawal syndrome that you would go through if you suddenly stop, there is no downside to stopping Xenical or Alli," says Wolfe.

Both Xenical and Alli are medications that contain the drug orlistat and work to block the body's ability to absorb dietary fat.

The urging from Public Citizen to remove the drugs from the market follows a May 2010 warning issued by the FDA, noting 13 reports of severe liver injury in patients taking orlistat. Public Citizen stated that 73 cases of kidney stones have also been linked to use of the medications.

Find more at public citizen

More information the Topamax Recall

About 57,000 bottles of the prescription anti-seizure drug Topamax are being recalled due to customer complaints of an "uncharacteristic odor," said J and J.

The recall affects two lots of Topamax 100 milligrams tablets shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico. The tablets were made by Johnson & Johnson's Ortho-McNeil Neurologics division, CNN.com reported.

There were four consumer complaints about an odor believed to be caused by trace amounts of the chemical TBA (2,4,6 tribromoanisole), which is applied to wooden pallets used to transport and store packaging materials.

http://www.businessweek.com/lifestyle/content/healthday/651924.html

On March 4, 2011, the FDA announced new data suggesting that babies born to women who took Topamax during their first trimester have an increased risk of birth defects.

Birth defects associated with Topamax use include but are not limited to:

• Cleft Lip
• Cleft Palate
• Genital Defects
• Fetal and Skeletal Malformations

A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a split or gap in the roof of the mouth. These deformities may cause developmental issues and can lead to severe ear infections and problems with eating and talking.

Novedex Recall

By now folks have read about the Novedex Recall. 

Possible Side Effects

Potential adverse events associated with the use of anti-aromatases could include:

• Decreased rate of bone maturation and growth
• Decreased sperm production
• Infertility
• Aggressive behavior
• Adrenal insufficiency
• Kidney failure
• Liver dysfunction
• Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events

From the FDA site:

Gaspari 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.

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling two lots of TOPAMAX® (topiramate) 100mg Tablets.  These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico.  While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace.  The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Package Description	NDC Code	Lot Number	Expiry
TOPAMAX® (topiramate) TABLETS 100mg  Bottles of 60 Tablets	50458-641-65	0KG110	06-2012
		0LG222	09-2012

TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.  In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood.  An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue.   In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

Source is the J and J site:   Here.

Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine

From the FDA site:

The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition.

FDA believes the risks and benefits of using TNF blockers, azathioprine, and/or mercaptopurine should be carefully weighed when prescribing these drugs to children and young adults, especially for the treatment of Crohn’s disease and ulcerative colitis. Patients should continue to talk to their Healthcare Professionals about the potential risk of HSTCL with use of these medications in order to make the best decision about their medical treatment.

The product labels for Remicade (infliximab) and Humira (adalimumab) have been updated and the product labels for azathioprine and mercaptopurine are being updated to include warnings about HSTCL that have been reported in patients treated with these products
http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm

U-Prosta Recalled

USA Far Ocean Group (Alhambra, CA) voluntarily recalled their product, U-Prosta, a dietary supplement for prostate health .

USA Far Ocean Group is the maker of the product, and it was told by the FDA that laboratory analyses of U-Prosta revealed samples of the product contained terazosin, an active ingredient of an FDA-approved drug to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.


Patients treated for high blood pressure or enlarged prostate who taking U-Prosta could experience some adverse affects, such as hypotension, dizziness or syncope.

 Low blood pressure, or hypotension, occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, brain, and other parts of the body do not get enough blood.

Syncope (SIN'ko-pe) is temporary loss of consciousness and posture, described as "fainting" or "passing out.
U-Prosta has been sold and distributed nationwide through retails stores, Internet sales and by mail order. The U-Prosta products involved in this recall are:

U-Prosta Dietary Supplement 60 Capsules 689076499255
U-Prosta Dietary Supplement 30 Capsules 88858100030
U-Prosta Dietary Supplement 1 Capsule No UPC Code

Nutrition Express Voluntarily Recalls Protein Supplements Because Of Possible Health Risk

A company called Nutrition Express  has voluntarily recalled specific products containing whey protein isolate sourced from one supplier because they have the potential to be contaminated with Salmonella. 
 
Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. A limited number of products were sold between December 1, 2010 and February 17, 2011.

About 450 bottles of powdered protein were sold at two retail health food stores only (Lindberg Nutrition located in Torrance and Manhattan Beach), both in Los Angeles County, California. Notice of the recall was immediately posted at both stores. The only other sales channel was a direct-to-consumer channel from Nutrition Express, the exclusive distributor of these products.

The products were shipped directly to consumers in the United States via Federal Express or the U.S. Post Office. All consumers, who bought through this direct channel, were immediately sent letters on February 22, 2011 by Nutrition Express regarding the specific recalled product that they purchased.

Source here. 

Alcohol a major cause of cancer?

Image via Wikipedia

From Yahoo:
 

About one in 10 cancers in men and one in 33 in women in western European countries are caused by current and past alcohol consumption, according to a study released on Friday. For some types of cancer, the rates are significantly higher, it said.

In 2008, for men, 44, 25 and 33 percent of upper digestive track, liver and colon cancers respectively were caused by alcohol in six of the countries examined, the study found. The countries were Britain, Italy, Spain, Greece, Germany and Denmark.

April Darvocet Update: JPML Panel Defers Decision Until Late Summer

Image by amayzun via Flickr

From the JPML Order:

On the basis of the papers filed and hearing session held, the Panel has decided to defer its decision on this Section 1407 motion pending further argument at the July 2011 Panel hearing session. Moving and responding plaintiffs and defendants have made persuasive arguments for and against centralization.

Since this Section 1407 motion was filed on December 15, 2010,less than two weeks after the first case commenced, this litigation has grown from four actions involving one defendant to encompass eighteen currently known actions involving more than a dozen different defendants. Consideration of this Section 1407 motion so soon after a handful of actions were filed, where the contours of the litigation are in flux, leaves the Panel with less than ideal information to make the best possible decision. For example, most of the known parties in this litigation, including ten of the thirteen defendants, have not had an opportunity to express their views on the merits of Section 1407 centralization. This is a potentially complex case. Our desire to make the most informed possible decision counsels further deliberation.

With these considerations in mind, the Panel will issue a show cause order setting forth an additional briefing schedule, and further argument for our July 2011 Panel hearing session. While deferring our ruling does delay the Panel’s decision-making process, in the interim, these cases can proceed in the transferor courts. See Panel Rule 2.1(d). In the longer term, this continuation will assure that all parties have an opportunity to be heard, enhance our decision-making process, and should not prejudice the benefits of centralization, if that is our ultimate judgment. 

Find the Order here: http://www.jpml.uscourts.gov/Panel_Orders/panel_orders.html 

Stop Using Soladek Vitamin Solution

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.

FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins.  Intake of excessively high levels of these vitamins poses a risk to human health.

The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.

Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately. 

Soladek cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA.  However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248588.htm

IV Meds Update - Birmingham, AL 4/4/11

Alabama health officials trying identify the source of bacteria suspected in the deaths of nine hospital patients and the sickening of 10 others said last week that the officials found the same bacteria in a pharmacy in Birmingham.

The pharmacy, IV Meds, of Birmingham, had prepared the intravenous feeding solutions that were administered to all of the patients in six hospitals in the state. Bacteria in their blood matched bacteria in a bag of the suspect product found in the pharmacy, he said.

Source:

Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)

The FDA rolled out a "Bad Ad" program last week that should make waves in the Pharma industry.

From their site:

FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The "Bad Ad" Program is administered by the agency’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.

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Frequently Asked Questions

1. Can I report anonymously?
Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.
2. Will DDMAC be able to stop the misleading promotion?          
In many cases, yes, especially if evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.
3. What will happen to my complaint once I have contacted DDMAC?          
The information you provide will be sent to the Regulatory Review Officer in DDMAC responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.
4. How do I learn more?
To learn more about DDMAC in-service training for large medical group/hospitals or to speak directly with a DDMAC Reviewer, call 301-796-1200.

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Recognize & Report: Contact Information

Division of Drug Marketing, Advertising, and Communications (DDMAC)⁵
Phone:           877-RX-DDMAC
                    (877-793-3622)
E-Mail:           BadAd@fda.gov
Write:            FDA/CDER/DDMAC
                    5901-B Ammendale Rd,                                        
                    Beltsville, MD 20705-1266  
Fax:              301-847-8444

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Source: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

Fertility drug link to fatal disease?

Outside the US  there's news of an investigation into the safety of fertility drugs which may show that  the hormones - derived from pregnant or menopausal women's urine - could carry proteins similar to those linked to the fatal Creutzfeldt-Jakob disease.

This is news from the online journal PLoS One, for the first time confirmed the presence of the proteins in the drugs. They were not of the mutated form linked to the human version of mad cow disease, but the findings suggested these too might survive the production process. Source. 

Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder. It affects about one person in every one million people per year worldwide; in the United States there are about 200 cases per year. CJD usually appears in later life and runs a rapid course. Typically, onset of symptoms occurs about age 60, and about 90 percent of individuals die within 1 year. In the early stages of disease, people may have failing memory, behavioral changes, lack of coordination and visual disturbances. As the illness progresses, mental deterioration becomes pronounced and involuntary movements, blindness, weakness of extremities, and coma may occur.

There are three major categories of CJD:

• In sporadic CJD, the disease appears even though the person has no known risk factors for the disease. This is by far the most common type of CJD and accounts for at least 85 percent of cases.
• In hereditary CJD, the person has a family history of the disease and/or tests positive for a genetic mutation associated with CJD. About 5 to 10 percent of cases of CJD in the United States are hereditary.
• In acquired CJD, the disease is transmitted by exposure to brain or nervous system tissue, usually through certain medical procedures. There is no evidence that CJD is contagious through casual contact with a CJD patient. Since CJD was first described in 1920, fewer than 1 percent of cases have been acquired CJD.

CJD belongs to a family of human and animal diseases known as the transmissible spongiform encephalopathies (TSEs). Spongiform refers to the characteristic appearance of infected brains, which become filled with holes until they resemble sponges under a microscope. CJD is the most common of the known human TSEs. 

Source.