Articles Posted in Drug Warnings

The Food and Drug Administration (FDA) has considered changes to its labeling rules regarding generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

Last month brought changes to fifty-three (53) medical product labels (way up from 35 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

Last month brought changes to thirty-five (35) medical product labels (up from 27 changes in January), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

A federal court in Connecticut kept alive a Prempro breast cancer wrongful death case, denying Wyeth’s pretrial motion for summary judgment. Plaintiffs’ brought the classic Prempro case against Wyeth who makes the hormone therapy drugs Premarin, an estrogen, and Prempro, a combination of Premarin and a progestin, which are both prescribed to combat the symptoms of menopause. The plaintiffs’ wrongful death lawsuit claims that a woman died of breast cancer using these drugs that were unreasonably dangerous and that they lacked adequate warnings.

Wyeth argued that the Connecticut Product Liability Act does not recognize strict liability design defect cases, contending that the infamous common K of Section 402A of the Second Restatement of Torts.

Section 402A imposes strict liability for defective products that are found to be unreasonably dangerous to the end-user. Comment K suggests an exception for products that are “unavoidably unsafe.”  This Connecticut federal court found that comment K should not be applied uniformly to prescription drugs. Instead, each drug should be considered on a case-by-case basis.

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Studies have suggested that taking statins, which are medications used to lower cholesterol levels, may increase the risk of developing diabetes, particularly in women. However, the overall risk of developing diabetes is still low and the benefits of taking statins, such as reducing the risk of heart disease, stroke and other cardiovascular events, typically outweigh the potential risks.

Statins, often called wonder drugs, are medicines taken to lower cholesterol levels. Zocor, Lipitor, and Crestor are the most popular of these medications that reduce the risk of heart disease and stroke. Tens of millions of Americans take these medications, but a recent study that followed over 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Doctors say that don’t know why statins increase diabetes and that the research does not implicate any single brand. These findings seem to confirm prior smaller studies.

Now, I’m not saying that anyone should panic and stop taking their medication since heart disease is one of the major complications of diabetes, but the risk is certainly something to consider and, ultimately, discuss with your doctor. Does the benefit outweigh the risk? It will depend on the patient.

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

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Johnson & Johnson’s HIV drug Intelence may cause deadly allergic reactions and liver damage. It has been linked to Stevens-Johnson Syndrome (also known as toxic epidermal necrolysis), an allergic reaction that starts with flu-like symptoms and a rash, and which may develop into blisters and shedding of skin. There has been one reported death from Intelence-related Stevens-Johnson Syndrome.

The drug company has appropriately warned physicians to watch for possible reactions, and the drug’s label has been revised.

Intelence History

The FDA just issued a press release describing problems with TNF Blockers. TNF blockers have been approved for the treatment of immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

The problems are severe—these drugs may cause an increased risk of lymphoma, leukemia, and other cancers, particularly in children. The FDA first disclosed problems in a June 4, 2008 communication, based on about 30 reports of cancer in children. The updated FDA analysis leading to this week’s warning is based on a review of 48 cases of malignancies, including 11 deaths. The FDA also had reports of 147 cases of leukemia in children and adults, including 30 deaths. It is still unclear how strong the association is, because there is a small population of children on TNF blockers, and those children are typically concurrently prescribed other immunosuppressive therapies.

Examples of these TNF blockers include:

Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we will continue calling it a “black box warning”). This week, we had a one day trial that turned into a three-day trial, so we’re just now getting to follow up on it.

The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion), and generic smoking cessation drugs (note—bupropion like Wellbutrin are often prescribed for depression and seasonal affective disorder). Besides the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who have been prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.

The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a potential problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.