Pfizer issue warning over birth control shot danger

The U.S. Food and Drug Administration (FDA) has approved a major safety update to the label of Depo-Provera, a widely used birth control injection. 

Nearly 2,000 women have filed lawsuits against Pfizer, alleging they developed a type of brain tumor known as meningiomas and claiming such were caused by Depo-Provera. 

According to MD Anderson, meningioma is a tumor that forms on the membranes surrounding the brain and spinal cord, known as the meninges.  

While most meningiomas are benign, about 20 percent grow more aggressively and fewer than 3 percent are cancerous. The symptoms can include persistent headaches, seizures, personality changes, weakness or numbness in the face or limbs, and vision problems. 

Attorneys Bryan Aylstock, Christopher Seeger and Ellen Relki, co-lead counsel in the Depo-Provera Products Liability Litigation, said in a statement: “We applaud the FDA in finally requiring this label change to better inform and protect women. We are committed to pursuing justice for the thousands of women whose lives were shattered when they developed brain tumors caused by Depo-Provera and suffered lasting neurological damage, vision loss, and death due to Pfizer’s misconduct.” 

What Changed?

On December 12, the FDA updated the Warnings and Precautions section of the Depo-Provera Contraceptive Injection (CI) label to include: “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.” 

Patients are encouraged to discontinue Depo-Provera CI if a meningioma is diagnosed. 

A spokesperson from Pfizer told Newsweek: “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.”

How Common Is Depo-Provera Use?

Depo-Provera has been a popular contraceptive option for decades.  According to the Centers for Disease Control and Prevention (CDC), about one-in-four sexually experienced women has used the injectable contraceptive Depo-Provera. 

Another CDC reports nearly one-half of the 12.5 million women who had used Depo-Provera (46%) discontinued use due to dissatisfaction. Of the women who had ever used and discontinued using Depo-Provera, 74 percent cited side effects as a reason. 

Among those who stopped, 74 percent cited side effects as the main reason, followed by menstrual cycle changes (31 percent). 

Previously the side effects listed on the label included:

• Bone loss;
• Breast cancer;
• Blood clots and stroke;
• Ectopic pregnancy;
• Severe allergic reactions: including serious eye problems or loss of vision;
• Other health effects: may trigger migraines, depression, seizures, or liver problems.

Legal Action and Personal Stories

The label change comes amid growing legal scrutiny. Newsweek previously spoke to two of of the plaintiffs who are filing separate cases against Pfizer, who both required brain surgery after being diagnosed with meningiomas. 

“I was never told that Depo-Provera might be linked to meningiomas,” Sandra Somaraki, now 61, said. Sixteen months after starting the injections, she began suffering severe headaches. Another tumor was later discovered.

“The neurologist was shocked,” she added.

Nicole Ryan, 60, was diagnosed in 2014 after suffering from constant lightheadedness, near fainting spells and hearing loss in her left ear. 

She told Newsweek: “Although the surgery [to treat the tumor] was successful, I was left with permanent side effects such as permanent ringing in my left ear, poor balance, and headaches where the tumor was taken out.” 

What Patients Should Know

Patients should remain vigilant for symptoms such as persistent headaches, vision changes, or other neurological issues and seek immediate medical evaluation if they occur.

Those concerned about potential risks are advised to speak with their healthcare provider about alternative contraceptive options to ensure the safest choice for their individual needs.

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