FDA approves generic Yaz despite serious blood clot warnings

Yaz, and other birth control pills made with the hormone drospirenone, have been shown in studies to put women at greater risk for developing deadly blood clots, yet generic versions of the drug are still being approved for sale in the United States. Watson Pharmaceuticals Inc. has just been granted approval by the Food and Drug Administration (FDA) for Vestura, its generic version of Bayer’s Yaz.

Watson wants to take a bite out of the $173 million in sales Yaz has generated for the 12 months ended on September 30. The drug company is currently in a patent dispute with Bayer regarding Yaz.

Vestura joins others in this newer formulation of oral contraceptives that contain the hormone drospirenine. Others in this class include Yaz, Yasmin, Beyaz and Safyral.

An FDA advisory panel recently reviewed studies on the safety of drospirenone-containing pills that showed the pills appear to put users at greater risk for blood clots, heart attacks, strokes and even death. The pills have also been associated with gallbladder damage. The committee ultimately recommended stronger warnings be placed on the drugs’ packages. The FDA is not required to follow the advice of its advisory panels, but it usually does.

Bayer is currently embroiled in thousands of lawsuits over its family of drospirenone-containing pills from women who claim the drug company knew the drugs were dangerous but continued to sell them.

Source: WSJ