A LOOK BACK AT FDA ACTIONS CONCERNING AVANDIA | Dallas, Texas Personal Injury Attorney Blog

2007 NEW ENGLAND JOURNAL OF MEDICINE ARTICLE

After a 2007 study published in the New England Journal of Medicine showed a link between Avandia and an increased risk in heart attacks, on May 21, 2007, the Food and Drug Administration (FDA) issued a safety alert on May 21, 2007. However, the FDA did not ban the drug at that time or recommend that physicians take their patients off Avandia at that time, but instead promised a further investigation into the medication.

The study was conducted by two doctors at the Cleveland Clinic who evaluated 42 studies that compared patients taking Avandia with those who were not. The overall study involved 28,000 patients, 15,560 of whom were taking Avandia.

Of those patients taking Avandia,

1. 86 suffered heart attacks compared to 72 among patients not on the drug;
2. Another 39 patients died from cardiovascular causes compared to 22 patients who were not taking Avandia.

2007 BLACK BOX WARNING REQUIRED

In 2007, Seven Galson, the physician director of the FDA’s Center for Drug Evaluation and Research, announced that the FDA would analyze the information it has on the Avandia risk as soon as possible and make the results available. The FDA would also present the issue of Avandia’s potential heart attack side effect and the need for an Avandia warning or other action to an advisory committee as soon as one can be convened. Eventually, the FDA required a “black box warning,” the FDA’s most serious level of warning, for the increased risk of coronary problems in patients taking Avandia. In July of, 2007, the FDA announced that the manufacturer of Avandia (rosiglitazone) has agreed to add new information about potential increased risk for heart attacks to the existing boxed warning.

 

CONGRESSIONAL INVESTIGATIONS

Members of Congress have also expressed concern about the FDA handling of Avandia. Both houses of Congress are currently debating funding bills for the FDA that contain certain requirements for reform of the methods used by the FDA to monitor drug safety. Representatives John Dongell and Bart Stupac, both Democrats from Michigan, have vowed to investigate further whether GSK revealed the dangers of Avandia to the public. The House Oversight Committee held a hearing on the FDA’s handling of Avandia.

 

OTHER CONCERNS REGARDING AVANDIA

Another 2007 study raised additional concerns about Avandia side effects. The study found that Avandia increases the risks of fractures of the upper arm, hand, and foot of women taking it and two other drugs manufactured by GSK, Avandamet and Avandaryl. Since millions of people take this drug, bone deteriorization could have a major health impact.

 

SEPTEMBER 23, 2010: FDA ANNOUNCES SIGNIFICANT RESTRICTIONS

On September 22, 2010, Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA issued her memorandum finding that the drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE). The FDA noted that pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia. The FDA also noted that there is even a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies. As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.

On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

 

LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA

The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:

• Physical pain and suffering, mental anguish and physical impairment;
• Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
• Loss of earnings and/or earning capacity; and
• In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.

 

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