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GSK to work with U.S. officials after Avandia ruling

In this June 30 file photo, a pharmacist holds a bottle of Avandia pills at Maximart Pharmacy in Palo Alto, California.

In this June 30 file photo, a pharmacist holds a bottle of Avandia pills at Maximart Pharmacy in Palo Alto, California.

The maker of Avandia said they will continue working with U.S. regulators after most members of a key advisory committee recommended Wednesday the diabetes drug to stay on the market with greater restrictions on its sale.
The muted reaction by British pharmaceutical GlaxoSmithKline came after most of the expert panel members agreed that the drug increases the risk of heart problems.
But only 12 of the 33-member panel voted to remove the one-time blockbuster medication from the market.
"Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease," said Ellen Strahlman, GlaxoSmithKline's chief medical officer.
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 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.
"Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine," she said.
The panel voting Wednesday was convened at the FDA's request, but can offer only an advisory opinion that the U.S. regulatory agency is not bound to follow.
Pending the FDA's decision, the GSK statement read, Avandia "remains available to physicians and appropriate patients as an option to help control blood sugar in patients with Type 2 diabetes."


Updated : 2021-06-24 05:01 GMT+08:00