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Black box warning added to rosiglitazone label
The diabetes drug will remain on the market while safety assessments continue.
December 2007
The FDA has issued a revised boxed warning for rosiglitazone that highlights the potential increased risk for myocardial infarctions.
GlaxoSmithKline will add the new information to the existing boxed warning on rosiglitazone (Avandia) and has agreed to conduct extensive long-term trials to determine the drug’s cardiovascular safety. The FDA advised health care providers to closely monitor patients who take rosiglitazone for cardiovascular risks.
“FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings,” said Janet Woodcock, MD, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, FDA.
During the past year, FDA officials have reviewed data, some of which show conflicting results, related to the risk of chest pain, MI and heart-related deaths, and deaths from any cause in patients treated with rosiglitazone.
“At this time, the FDA has concluded that there isn’t enough evidence to indicate that the risks of MI or death are different between rosiglitazone and some other oral type 2 diabetes treatments. Therefore, the FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of rosiglitazone, compared to an active control agent,” the agency said in a press statement.
The revision of rosiglitazone’s existing boxed warning includes the following statement:
“A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or MI. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”
The previous upgraded warning, added to certain diabetes drugs on August 14, emphasized that these types of drugs may worsen HF in some patients. To date, no oral diabetes drug has been conclusively shown to reduce cardiovascular risk, according to the FDA. Consequently, the agency also requested all oral diabetes drug labels describe the lack of data showing this benefit.
This action follows recommendations made at a joint FDA meeting, held in July, in which committee members voted 22-to-1 to recommend that rosiglitazone stay on the market pending a review of additional data. The committee advised that information warning of the potential for increased risk of MI should be added to the drug labeling.