Product News and Recalls

Formulation with controversial compound approved

The federal Food and Drug Administration has approved a new, lower-dose formulation of a Bayer corporation drug used to treat menopausal symptoms.

The drug Angeliq contains drospirenone, a synthetic progestogen that may elevate the levels of potassium in the body.

“We are pleased by the approval of this important new lower-dose option for menopausal women,” Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. “The availability of the new lower dose of Angeliq supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose.”

Birth control pills that contain drospirenone – including Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah – have been the basis of more than 10,000 federal court lawsuits. Many of these pills are manufactured by Bayer. Plaintiffs claim they weren’t adequately warned of the drug’s harmful side effects, including an increased risk of potentially lethal blood clots, strokes, and pulmonary embolisms.