The U.S. Food and Drug Administration (FDA) has mandated a significant safety update to the label of Depo-Provera, a widely used contraceptive injection by Pfizer. This change follows the filing of nearly 2,000 lawsuits by women who allege that the injection caused them to develop meningiomas, a type of brain tumor.
According to research from MD Anderson, meningiomas develop on the membranes surrounding the brain and spinal cord, known as the meninges. While most meningiomas are benign, approximately 20 percent exhibit aggressive growth, and fewer than 3 percent are classified as cancerous. Symptoms can include persistent headaches, seizures, and vision problems, which significantly impact patients’ quality of life.
Bryan Aylstock, Christopher Seeger, and Ellen Relki, who serve as co-lead counsel in the ongoing litigation, expressed their approval of the FDA’s decision to update the warning label. “We applaud the FDA in finally requiring this label change to better inform and protect women,” they stated. The attorneys are dedicated to pursuing justice for women who claim to have suffered severe health consequences, including lasting neurological damage.
Details of the FDA Update
On December 12, 2023, the FDA revised the “Warnings and Precautions” section of the Depo-Provera label. It now includes an explicit warning regarding the potential risk of meningiomas associated with long-term use of medroxyprogesterone acetate, the active ingredient in the injection. The agency advises healthcare providers to monitor patients receiving Depo-Provera for signs and symptoms of meningioma and recommends discontinuation of the injection if diagnosed.
A Pfizer spokesperson informed that patient safety remains the company’s priority. “We conduct rigorous and continuous monitoring of all of our medicines, including assessments of reported adverse events,” the spokesperson stated. The company is actively working with the FDA to update both the prescribing and patient information for Depo-Provera to reflect the new meningioma warning.
Understanding Depo-Provera’s Popularity and Risks
Depo-Provera has been a preferred contraceptive option for many women for decades. Data from the Centers for Disease Control and Prevention (CDC) indicates that approximately one in four sexually experienced women have used this injectable contraceptive. Despite its popularity, nearly 46 percent of the 12.5 million women who ever used Depo-Provera discontinued it, primarily due to dissatisfaction. Notably, 74 percent of those who stopped cited side effects, including changes in the menstrual cycle and other health concerns.
Previously, the label listed several potential side effects, including bone loss, blood clots, and severe allergic reactions. The inclusion of meningiomas in the updated warning reflects growing awareness and scrutiny regarding the injection’s safety profile.
Legal actions against Pfizer are intensifying as more women come forward. Two plaintiffs, Sandra Somaraki and Nicole Ryan, shared their harrowing experiences with the medication. Somaraki, now 61, reported developing severe headaches shortly after starting Depo-Provera, which led to the discovery of a tumor. Ryan, aged 60, underwent surgery for a meningioma in 2014 after experiencing debilitating symptoms.
“I was never told that Depo-Provera might be linked to meningiomas,” Somaraki stated, highlighting the lack of awareness surrounding the potential risks. Ryan echoed similar sentiments, noting her ongoing struggles with side effects, including permanent ringing in her ear and balance issues following her surgery.
Patients are urged to remain vigilant for any symptoms associated with meningiomas, such as persistent headaches and vision changes. Those concerned about the risks of Depo-Provera are encouraged to discuss alternative contraceptive options with their healthcare providers to ensure they make informed decisions regarding their reproductive health.
