European regulators ordered the
diabetes drug Avandia off the market and the U.S. Food and Drug Administration
placed stringent restrictions on its use in the United States, saying heart
attack risks associated with the former blockbuster are too great a safety
concern to continue its use for most people.
In simultaneous news briefings
Thursday, the European Medicines Agency and the U.S. Food and Drug
Administration announced their long-awaited decisions on the fate of
GlaxoSmithKline’s controversial drug.
The European regulator said it
would stop authorizing marketing of Avandia, which will be off the market
within the next few months.
The FDA said new patients will be
able to get a prescription for Avandia, but only if they can’t control their
blood sugar with other medications. Doctors will have to document that their
patients are eligible to receive the drug and have been briefed on its risks.
FDA expects the restricted plan “will limit use of Avandia
“Although the European
Medicines Agency went further by actually suspended marketing of the drug, both
regulatory decisions result in essentially the same outcome, virtually complete
elimination of the use of this drug by patients around the world,” said
Dr. Steve Nissen of the Cleveland Clinic. Nissen, who published the first paper
linking Avandia to heart risks, said only a small number of U.S. patients would
receive the drug under the new restrictions.
GlaxoSmithKline’s chief medical
officer, Dr. Ellen Strahlman, said in a statement that the company will
voluntarily stop promoting Avandia in all countries where it operates.
“The company continues to
believe that Avandia is an important treatment for patients with type 2 diabetes
and is now working with the FDA and EMA to implement the required
The safety of Avandia, the brand
name for rosiglitazone, has been the top drug safety controversy facing the
FDA, and its split from European regulators is sure to draw criticism from
public safety advocates and confuse patients.
The FDA’s top drug reviewer said
the evidence against Avandia was not strong enough to warrant withdrawal.
The European Commission still must
approve the recommendations by the European Medicines Agency, a process that
could take several weeks. Decisions by the health regulators usually are not