The Wall Street Journal reports:
WASHINGTON—The Food and Drug Administration decided to allow the diabetes drug Avandia to remain on the U.S. market with new restrictions, while the European Medicines Agency suspended use of the product Thursday.
The FDA said the restrictions are aimed at reducing use of Avandia and other medications that contain the same ingredient. GlaxoSmithKline will be required to develop a restricted access program for Avandia, which would make it available only if other types of drugs fail to properly control high blood sugar levels seen with diabetes and they areunable to take a similar drug, Actos.
Patients currently taking Avandia can continue on the medication if they choose to. FDA Commissioner Margaret Hamburg said the FDA and EMA made their own decisions based on the same data. However, she said the EMA doesn't have a similar mechanism that FDA has to restrict access to a drug, explaining the divergent decisions.
The restricted access program applies to Avandia and as well as two other drugs that combine the active ingredient in Avandia with other diabetes medications. Those medications are sold by Glaxo under the brand names Avandamet and Avandaryl.
"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," the FDA said in a statement.
The FDA said doctors will have to attest to and document their patients' eligibility to receive Avandia and patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.
Kudos to Peggy Hamburg who, once again, reminds everyone that the science is the only thing that counts.
And science, as those who know understand, is plenty contentious enough.
