Wedoany.com Report-Dec.19, The United States Food and Drug Administration (FDA) has approved an update to the labeling of Pfizer's injectable contraceptive, Depo-Provera (medroxyprogesterone acetate), to include a warning about an elevated risk of meningioma associated with its use.

The FDA has approved a label change to Pfizer's contraceptive injection, Depo Provera, which will warn prescribers and patients of the increased risk of meningioma associated with the drug's use.

Depo-Provera, which contains a synthetic form of progesterone known as progestin, has been available as a contraceptive option since the early 1990s. The decision follows evidence from a study published in the British Medical Journal indicating a higher risk of intracranial meningioma with prolonged administration.

Meningiomas are tumors that develop in the membranes surrounding the brain and spinal cord. Common symptoms include headaches, seizures, weakness, and numbness. Although often benign, they can significantly affect quality of life and, in certain instances, pose serious health risks.

A National Health Statistics Report from December 2023 indicates that approximately 24.5% of sexually experienced women in the United States reported using Depo-Provera at some point between 2015 and 2019.

The FDA's approval of the label change represents a shift, as the agency had previously declined a similar request from Pfizer in 2024.

The updated labeling may impact ongoing litigation involving Pfizer and more than 2,000 women who have filed lawsuits claiming they developed meningiomas linked to the contraceptive. The claims focus on whether adequate information about potential risks was provided to healthcare providers and patients.

Ben Martin, founder of the Ben Martin Law Group, commented on the development: "This 'impossibility' pre-emption argument should now fail given that a warning was not only possible but that the FDA is now requiring such a warning.

"Pfizer has known for decades that there may be an association between the use of Depo-Provera and the development of meningiomas."

He noted that further research into this connection could have identified the increased risk compared to non-use.

Co-lead counsel in the litigation, Bryan Aylstock of Aylstock Witkin Kreis & Overholtz, Christopher Seeger of Seeger Weiss, and Ellen Relkin of Weitz & Luxenberg, stated that the label change supports efforts to inform women about potential effects. "We applaud the FDA in finally requiring this label change to better inform and protect women," they concluded.

The FDA's action aims to ensure users and healthcare professionals have access to updated safety information regarding the contraceptive.