Articles Posted in FDA/Voluntary Recalls

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Accutane is being taken off of shelves by manufacturer Roche Holding AG after yet another successful jury verdict found that the drug causes inflammatory bowel disease (IBD). Jury verdicts for IBD have totaled about $33 million to date.

The drug was introduced in 1982, has been taken by 13 million people, and was the company’s second-best-selling drug before generic drugs began competing with it in 2002. After that time, the manufacturer only has 5% of the market share.

The drug has been besieged by lawsuits for some time. Besides suits alleging the drug causes IBD, other suits allege the drug causes birth defects and depression. You may recall a recent suit by U.S Representative Bart Stupak of Michigan, who alleged that his son’s suicide was caused by Accutane (the judge granted summary judgment in favor of the company, there).

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For two years, Florida attorney Frederick Schaffer has sought the answer to his lack of smell. He’s gone to doctor after doctor, searching for a solution and cause to the medical condition known as anosmia. He had a camera rammed down his nasal passage, as well as an MRI and a CT scan. He’s visited specialists. But he finally realized the problem when he saw the FDA’s recall of Zicam.

Schaffer’s claims really highlight what tort victims understand, but the general public often overlooks. Seemingly insignificant injuries often have a lifelong cost. Schaffer misses the smell of coffee (which most people use to help wake up). He misses his wife’s perfume. He misses the smell of his kids’ hair after they’ve taken baths.

The smell is also intricately enmeshed in our sense of taste. Imagine not being able to really taste homemade apple pie, much less smell it. Losing that one sense dulls the taste buds. And, if it can’t be corrected, that’s a lifelong condition. How much is that worth?

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Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.

Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.

However, earlier this year the FDA required makers of Reglan and other metoclopramide medications to put a black box warning on their labels, the most stringent act the FDA can take. That label now reads:

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New from Twitter (side-issue—I’ve been trying to figure out decent work-related uses for Twitter for some time. This might be it—I can get instantaneous reports from the FDA about recalls and other safety issues related to drugs and devices—if you’d like to join the club, then just go to your Twitter account, search for the FDA, and click ‘Follow’): the FDA just posted a recall from AS Medication Solutions, LLC. AS Medication distributes Digoxin 0.25 mg tablets under the Caraco brand.

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Digoxin is used to treat heart failure and abnormal heart rhythms. The drugs are being pulled because some tablets may have more or less of the active ingredient. I’ve been to seminars about this drug, and my understanding is that there is a very narrow range of therapeutic benefits. The analogy is that a patient’s digoxin levels are represented by a ball balanced on the point of a pyramid—too much digoxin, even by a bit, will cause the levels to rapidly change, with disastrous results (including cardiac instability, slow heart rate, and death).

Plaintiffs’ lawyers have been advertising for digoxin cases for some time—a word first came out of the problems with Digitek tablets in April 2008 (trademarked by Activis Totowa, distributed by Mylan Pharmaceuticals Inc. under a Bertek label, and distributed by UDL Laboratories, Inc. under a UDL label). Those pills, manufactured in New Jersey, were reported to have a similar problem—some of the pills were supposedly “double-thick.” While there were verified accounts of major problems with the manufacturing facility in that instance, I don’t know of any lawyers who actually located any double-strength pills. The cases moved rapidly in the beginning but seemed to lose steam.

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Biosite Incorporated has announced a voluntary recall for one lot of its Triage Cardiac Panel (Catalog No. 97000HS, Lot #W44467B). The test is designed to be used by healthcare professionals to help diagnose heart attacks. The issue, as I understand it, is that the recalled lot may report falsely low values of CK-MB, myoglobin, and troponin I, which are proteins that increase when a heart attack is occurring. What this means is that the test under-reports potential heart attacks—the worst possible scenario.

Kudos to the manufacturer, Biosite for instituting the recall. However, I can’t help but notice that Biosite’s website makes absolutely no mention of the recall—despite today being one week after the press release. If I’m a doctor and I hear about the recall in passing, my first stop will be to the internet to get some solid information. This is the information age—there is no excuse not to use the most widespread means of communication, especially when lives are in danger.

What were we just saying about responsible corporations?

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The title of this blog sounds like an oxymoron. But it is the subject of an interesting article in Reliable Plant on how a swift recall and restitution to consumers can minimize harm to the company – and even improve customer satisfaction after the recall.

Of course, it depends on the product. Hydroxycut is through. Samantha Jones (little Sex and the City reference) herself could not save Hydroxycut. But the author cites the Tylenol scare in the 80s as a good example:

The best example of how to deal with a product recall is the Tylenol tampering case in the 1980s. Johnson & Johnson demonstrated that the safety of consumers was paramount by swiftly recalling the product, cooperating fully with regulators, and communicating openly about the issue, the researchers noted. Subsequently, the firm undertook a series of operational and design measures to ensure that such tampering would not occur again.

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The FDA is now requiring the makers of two prescription topical testosterone gel products to include a boxed warning on the labels. The move comes after reports of inadvertent exposure to eight children, aged nine months to five years. The drug is topically applied on the shoulders, arms, or abdomen. When transferred to children through secondary exposure (for example, children touching skin covered in the gel), the drug can cause enlargement of the genitalia, premature development of pubic hair, advanced bone age, and aggressive behavior.

The manufacturers of these products, Solvay Pharmaceuticals (AndroGel 1%) and Auxilium Pharmaceuticals (Testim 1%), already warn against exposure to the drug by children; however, the black box warning will enhance the visibility of the warning on the package inserts. Black box warnings are among the strongest safety measures the FDA can take, being reserved for medications with serious or life-threatening dangers.

There’s nothing to indicate that the companies did anything wrong—the dangers of secondary exposure are clearly noted in PDR guides, which warn against allowing others to come into contact with gel-covered skin. And of course, doctors who prescribe the medication should warn their patients about these risks.

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On Friday, May 1, the FDA issued a press release warning consumers to stop using Hydroxycut products, which have been associated with serious liver injuries. The manufacturer, Iovate Health Sciences Inc. has recalled Hydroxycut (also marketed under the MuscleTech brand name) from the market. The FDA reports that over 9 million units of Hydroxycut products were sold in 2008.

The recalls come on the heels of 23 reports of injury, including one death, over the past seven years. Those injuries include liver failure, jaundice, seizures, rhabdomyolysis (muscle damage), and cardiovascular problems. Symptoms may include brown urine, nausea, vomiting, fatigue, stomach pain, itching, and light-colored stools.

The recall affects: