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By Bill Berkrot and Ransdell Pierson
Nov 25 (Reuters) - U.S. health regulators said on Mondaythey would lift restrictions on the use of GlaxoSmithKline Plc's once widely prescribed diabetes drug Avandia, afterdetermining that it did not increase the risk of heart attacks.
The U.S. Food and Drug Administration, following its reviewof a large clinical trial aimed at determining the drug's heartsafety called Record, said it found that the trial showed noelevated risk of heart attack or death in patients being treatedwith Avandia when compared with standard-of-care diabetes drugs.
These data do not confirm the signal of increased risk ofheart attacks that was found in an analysis of previous clinicaltrials first reported in 2007, the FDA said in a statement.
Avandia, which had been one of Glaxo's top-selling medicineswith sales of $3.2 billion in 2006, was pulled from the marketin Europe and had severe restrictions placed on its use in theUnited States in 2010 due in part to ambiguity about a possibleincreased risk of heart attack and stroke seen in the Recordstudy, as well as a review of other studies.
The drug was placed in a highly unfavorable light in 2007after Dr. Steven Nissen, head of cardiology at the ClevelandClinic, reported results of a so-called meta-analysis in which data from 42 studies was pooled and analyzed, showing a 43percent increased risk of heart attack from Avandia.
GlaxoSmithKline could not immediately be reached to commenton the FDA decision. But the British drugmaker had previouslysaid it was not likely to put its marketing muscle behindAvandia again, even if the FDA were to lift usage restrictions.Its U.S. patent protection lapsed in 2011.
"Without patent protection, you probably won't see anymarketing spending, or anyone out there promoting Avandia," saidMorningstar analyst Damien Conover.
In June, Glaxo said Avandia was being taken by only about3,000 Americans, down from 120,000 before the restrictions wereput in place.
"Our actions today reflect the most current scientificknowledge about the risks and benefits of this drug," JanetWoodcock, director of the FDA's Center for Drug Evaluation andResearch, said in a statement.
"Given these new results, our level of concern isconsiderably reduced; thus, we are requiring the removal ofcertain prescribing restrictions," Woodcock said.
The FDA decision comes after an independent analysis of theRecord study earlier this year appeared to back the safety ofAvandia. The FDA had commissioned the Duke Clinical ResearchInstitute three years ago to analyze, or "readjudicate," datafrom the heart safety trial and report its findings to theagency.
The FDA said it will order changes to the Avandia label toreflect its updated position on cardiovascular safety, will nolonger require physicians to register Avandia patients into aRisk Evaluation and Mitigation Strategy (REMS) program, and thatdiabetes patients will again be able to receive Avandia throughregular retail pharmacies and mail order pharmacies.
The agency also dropped a requirement that Glaxo conduct astudy comparing Avandia to Actos, a diabetes drug from the sameclass of medicine as Avandia sold by Japanese drugmaker TakedaPharmaceutical Co.
"It's probably good for the medical community to have theoption" to prescribe Avandia, Conover said. "But it willprobably be reserved for patients that have failed other drugs,in part because of its checkered past."
