A majority of members of a key advisory committee recommended Wednesday that the US government allow diabetes drug Avandia to stay on the market with greater restrictions on its sale.
A majority of the panel’s members agreed that the drug does increase the risk of heart problems, but only 12 members of the 33-member expert panel voted to remove GlaxoSmithKline’s one-time blockbuster medication from the market.
A bloc of 20 members voted that the drug should stay on the market, with 17 urging greater restrictions such as revisions to the label, special warnings for at-risk patients or requirements for additional physician and patient education. One expert abstained from the vote.
The vote came at the end of a second day of hearings about the side-effects associated with the drug, which generated some 1.2 billion dollars in 2009 for Britain’s largest pharmaceutical firm.
Avandia has long been associated with an increased risk of heart attack and stroke, and a 2007 Food and Drug Administration study linking the medication to serious health concerns prompted authorities to slap a warning on it.
The panel voting Wednesday was convened at the FDA’s request, but can offer only an advisory opinion that the US regulatory agency is not bound to follow. “We look at the (vote) numbers but it’s not the only thing that the FDA is taking into account,” FDA spokeswoman Karen Riley told AFP.
Earlier Wednesday, the panel voted on a series of propositions about Avandia, including whether it was linked to heart problems and whether it was more likely to produce cardiovascular ailments than other similar drugs on the market.
Nineteen members of the panel endorsed a finding that the drug, which helps diabetics control their blood sugar, does increase the risk of heart attack or stroke in users.
Washington, July 14, 2010 (AFP)
