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European regulators said Thursday GlaxoSmithKline’s diabetes drug Avandia should be taken off the market but U.S. officials allowed it to stay, with major restrictions due to concerns about heart risks.
The differing rulings were an attempt to end a row over drug safety that has dogged the reputation of the medicine and its maker in recent years. Get the full story »
U.S. health advisers said GlaxoSmithKline Plc’s diabetes drug Avandia should be allowed to stay on the market in some form, easing a threat of further litigation that could have followed a ban.
Twenty of the 33-member panel of outside experts convened by the Food and Drug Administration voted for various options that would allow Avandia to stay on the market despite concerns over associated heart risks. Get the full story »
FDA scientists debated how to interpret the outcome of a large clinical trial that GlaxoSmithKline PLC says backs the safety of its diabetes drug Avandia.
Avandia is currently being reviewed by a federal panel that is scheduled to vote Wednesday on whether it thinks Avandia should remain on the U.S. market. FDA Commissioner Margaret Hamburg opened the meeting Tuesday, telling advisers to “follow the science where ever it may lead and the rest will fall into place.” Get the full story »
GlaxoSmithKline Plc insisted its diabetes pill Avandia was safe as U.S. advisers began a two-day meeting to consider whether the medicine is too dangerous to stay on the market.
The scientific experts assembled by the Food and Drug Administration are sorting through sharply conflicting data on whether Avandia causes heart attacks. Get the full story »
Two studies released Monday reported serious heart risks with GlaxoSmithKline Plc diabetes pill Avandia as U.S. regulators decide whether the drug should stay on the market.
An analysis of 56 clinical trials found Avandia increased the chances of a heart attack by 28 percent to 39 percent, researchers at the Cleveland Clinic in Ohio reported in an update to a 2007 study that sparked intense debate about the drug. Get the full story »
