FDA:  Depo-Provera Labels Must Warn of Meningioma Risk

Labels for Pfizer’s Depo-Provera contraceptive injection must now warn of the risk of meningioma, a type of brain tumor. The U.S. Food and Drug Administration (FDA) required the label change last week. The warning applies to two injectable forms of the drug, Depo-Provera CI and Depo-Subq Provera 104, which consist of progestin, a synthetic form of progesterone, administered as a shot every 3 months. The revised drug label will now state:

“Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if meningioma is diagnosed.”

According to lawsuits brought by thousands of women, studies from as far back as 1983 indicate a link between exposure to progesterone and development of meningioma.  

The complaints assert that Pfizer should have investigated the risk earlier, as a result of the studies’ findings. The lawsuits further assert that the pharmaceutical giant should have warned patients about the meningioma risk.

At a hearing on Friday, December 19, U.S. District Judge M. Casey Rodgers of the Northern District of Florida ordered lawyers to provide supplemental briefs for the thousands of Depo-Provera lawsuits she is overseeing in a multidistrict litigation (MDL).

“I will be requesting supplemental briefing regarding the impact that this approval of label change may have on the pending motions,” Rodgers said at the hearing.

Depo-Provera has been on the market since the early 1990s. Estimates from a National Health Statistics Report state that nearly 24.5% of all sexually experienced women in the US used the Depo “jab” between 2015 and 2019.

A study published in March 2024 in the British Medical Journal revealed the heightened risk of intracranial meningioma associated with prolonged use of the contraceptive shot.