The FDA has approved a label change on the long-acting injectable contraceptive depot medroxyprogesterone acetate, commonly known as Depo-Provera, to warn users of a potential risk of meningioma.

The FDA’s action follows mounting scientific evidence linking the medication to meningioma, a type of tumor that forms in the lining surrounding the brain. 

A study published in March last year in The BMJ found a fivefold increased risk for meningiomas among patients taking Depo-Provera. 

A separate study published in JAMA Neurology in September and covered by Medscape Medical News found a twofold increased risk for meningiomas in Depo-Provera users. The risk was greatest in women who began using the injection after age 31 years or who used it for 4 years or more. 

The updated label applies to Depo-Provera CI (intramuscular injection) and Depo-SubQ Provera 104 (subcutaneous injection), both manufactured by Pfizer. 

It states that “cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use.” 

The label advises monitoring of patients on Depo-Provera CI for signs and symptoms of meningioma and discontinuing the medication if a meningioma is diagnosed. Depo-Provera is contraindicated in patients with a meningioma or a history of meningioma.

The United States Judicial Panel on Multidistrict Litigation reports that more than 1400 lawsuits have been filed against Pfizer regarding Depo-Provera and meningiomas. 

Reached for comment by Medscape Medical News, Pfizer released the following statement:

Patient safety is Pfizer’s priority. We conduct rigorous and continuous monitoring of all of our medicines, including assessments of reported adverse events, in collaboration with health authorities around the world. Working with the U.S. Food and Drug Administration (FDA), Pfizer is in the process of updating the U.S. prescribing information and patient information for Depo-Provera to add a meningioma warning on the long-term use of progestogens. This label update reflects a recent decision by the FDA to approve the warning, which the agency had earlier denied.

Pfizer stands behind the safety and efficacy of Depo-Provera, which has been used by millions of women worldwide and remains an important treatment option for women seeking to manage their reproductive health.