Of­fi­cials over­turn safety lim­its on di­a­betes drug

The Washington Times Daily - - Business -

The Food and Drug Ad­min­is­tra­tion is lift­ing se­vere safety re­stric­tions on the for­mer block­buster di­a­betes pill Avan­dia, cit­ing re­cent data sug­gest­ing that the much-de­bated med­i­ca­tion does not in­crease the risk of heart at­tack.

The re­peal means pa­tients will no longer have to en­roll in a spe­cial reg­istry to be el­i­gi­ble to re­ceive the drug. That safety re­quire­ment, put in place in 2010, sharply re­duced Avan­dia pre­scrip­tions in the U.S.

The rul­ing is a be­lated vic­tory for Bri­tish drug­maker Glax­oSmithK­line PLC af­ter more than a half-decade de­fend­ing the safety of Avan­dia, which was once the best-sell­ing di­a­betes drug in the world.

Sales be­gan plum­met­ing in 2007 af­ter re­searchers first raised ques­tions about pos­si­ble links to heart at­tacks. Af­ter three years of de­bate,

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