Brazilian authorities, which earlier ordered drugmaker Bayer to pull its Essure birth control device from the market, have now asked for the recall of more than a dozen lots of a Bayer birth control pill.
Anvisa sought the recall of 13 lots of Bayer’s Gynera over questions of stability. Bayer, in its voluntary recall notice (in Portuguese), said this week that it has temporarily stopped production and distribution of the drug.
Bayer said that stability tests showed a change in the “profile of the stability study of Gynera,” but that the safety and efficacy of the birth control pills had not been affected. It said, however, that as a precautionary measure, it is recalling the 13 lots currently in the market.
In February, Anvisa announced (in Portuguese) that it was pulling Bayer's Essure implantable birth control device from the market after getting technical reports about its risks.
Bayer faces dozens of lawsuits in the U.S. over reported problems caused by the drug. Some of the lawsuits claim Bayer didn’t adequately warn patients and doctors of its risks.
Earlier this year, the FDA slapped a black-box warning on the device, indicating extreme risks and possible serious injuries associated with its use. The regulatory agency also told Bayer to conduct more postmarket studies of the device's safety.