Regulators apply brakes on Avandia
Friday, September 24, 2010
The diabetes drug Avandia will be pulled from the market in Europe and will only be available in the United States under tough new restrictions, regulators said Thursday in an unusual coordinated announcement.
The Food and Drug Administration and European Medicines Agency took the parallel actions after concluding there was significant evidence that the risk that Avandia could cause heart attacks and strokes outweighed the medicine's benefits for most patients.
Under the decisions, Avandia will be unavailable in Europe and U.S. patients will be allowed to take Avandia only if they are unable to control their blood sugar with other drugs. Doctors prescribing Avandia will have to justify the decision. Patients already taking the drug who want to continue will have to sign statements that they understand the risks. In the United States, about 600,000 diabetics take Avandia; the number is expected to decline significantly.
The highly anticipated decision, which will take effect in the next few months, marks the culmination of a long, bitter debate. Once the world's most popular diabetes drug, Avandia became the focus of disagreement over its safety and came to represent concern over the pharmaceutical industry's trustworthiness and the FDA's ability to police drug safety.
Although the FDA pledged to be tough on safety, the Avandia case created a dilemma. Scientists inside and outside the agency were divided about how to balance the drug's risks with the needs of diabetics, who often must try several different medications.
"The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," said Commissioner Margaret A. Hamburg. "We are seeking to strike the right balance."
Although some consumer advocates said the move fell short, some of the drug's most vocal critics indicated they were satisfied.
"The decisions today . . . bring an end to one of the worst drug safety tragedies in our lifetime. By severely restricting access to Avandia, the FDA is ensuring that only a few individuals in America will continue to take this drug," said Steven E. Nissen, the Cleveland Clinic cardiologist who first raised questions about Avandia's safety.
But Nissen added that the action took too long.
"In the aftermath of the demise of Avandia, it is essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future," Nissen said.
U.S. and European officials said they had been in close contact throughout their respective reviews - a sign of a more collaborative relationship between the agencies that has been in place since 2003 in part because of the globalization of the pharmaceutical industry. The difference in final outcomes reflected a combination of factors, including differences in regulatory processes, officials said. They coordinated their announcements to try to avoid confusion among patients.
It would not have been practical, for example, for the European agency to implement throughout Europe the kind of program the FDA has demanded. At the same time, the European agency stopped short of taking the most drastic action possible, which would have been a complete revocation of the drug's approval. Instead, officials recommended suspending the approval, leaving open the option of reinstating the drug if further data emerge.