FDA approves label change for Depo-Provera, adding brain tumor warning

The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.

The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.

Pfizer is currently battling a lawsuit in which more than 1,000 women claim the company knew about the risk and failed to warn patients.

The Depo-Provera regimen consists of a progestin injection given every three months. The lawsuit points to several studies dating as far back as 1983 showing a link between progesterone and meningioma, saying those studies created an “unassignable duty to investigate,” and that Pfizer should have studied the risks associated with Depo-Provera sooner. (Progestin is a synthetic version of progesterone.)

According to the Centers for Disease Control and Prevention, 1 in 4 sexually active women in the United States have used Depo-Provera. Black women use it at nearly double the national rate.

Meningiomas are usually not cancerous — meaning they don’t spread to other parts of the body — but they can be harmful depending on their size and where they grow. The overall risk of developing a meningioma remains small: About 39,000 meningiomas are diagnosed each year in the U.S.