The United States and Europe are both greatly restrict the use of the drug against the Avandia diabetes, culminating several years of concern the drug increases the risk of heart problems. The European Medicines Agency (EMA) taking Avandia from the market, while the United States Food and Drug Administration (FDA) is placing the drug in a special high-risk category that is likely to significantly reduce its use.
The two organizations had access to the same data of Avandia, which was compelling but incomplete. The conclusion that Avandia causes heart attacks and other heart problems came to combine data from many different clinical trials, a method that is statistically less powerful than individual trials designed to answer these questions. "My job would be infinitely easier if we had consensus and scientific clarity on this issue," said Margaret Hamburg, FDA commissioner, at a press conference this morning. But she found the evidence warrants significant restrictions.
most frustrating for regulators, a large clinical trial specifically requested by European regulators to address risks, called RECORD, is under fire for not properly assessing cardiac events. officials FDA said today that the next step will be to have the company that makes Avandia, GlaxoSmithKline, established an independent review committee to reassess all potential heart problems that have emerged in RECORD patients.
Meanwhile, Avandia will become much more difficult to obtain. FDA under a special program it runs called risk assessment and mitigation strategies. REMS is designed to ensure that the benefits of potentially dangerous drugs continue to outweigh the risks for each patient taking them. The program currently includes drugs such as Accutane medication against acne, which causes birth defects. The FDA also arrested a Glaxo trial which compared Avandia with another drug used by people with diabetes, Actos, which is considered safer. FDA suspended the trial in the summer.
In the case of Avandia, patients who wish to continue using it will have to sign a document acknowledging that they understand the risks of the drug. New patients will be eligible to take if doctors certify that other treatments have failed to provide blood sugar of patients under control and they can not take Actos for medical reasons. "We believe that this action will significantly limit the number of people who are on [Avandia]," said Janet Woodcock, director of the Center for evaluation and Drug Research in Silver Spring, Maryland.
for European regulators, which limits the use Avandia was considered inadequate, and in a few months Avandia will not be available in most European countries. "the accumulated data support an increased cardiovascular risk rosiglizatone," the generic name for Avandia, EMA said in a statement. "the benefits of rosiglitazone no longer outweigh its risks." But Woodcock noted that there was still "a lot of uncertainty about the extent and existence of this cardiovascular risk." She hopes that will help revaluing RECORD.
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