Bayer Must Include Safety Warnings of Increased Blood Clots on Yaz Labels, FDA Panel Rules

Share Article

Simmons Law Firm Continues to Investigate Safety Concerns Surrounding Yaz, Yasmin Pills

“Millions of women have been taking contraceptives like Yaz without fully understanding the risks associated with them”

An independent FDA panel has voted 21-5 to require Bayer AG to update warning labels on its popular birth control Yaz to reflect new concerns regarding the drug’s safety. The overwhelming majority decision comes in light of recent studies that suggest new contraceptives containing the hormone drospirenone may be more dangerous than older drugs. The Simmons Law Firm continues to investigate these safety concerns.

“Millions of women have been taking contraceptives like Yaz without fully understanding the risks associated with them,” said Trent Miracle, head of the Pharmaceutical Injury Litigation Department at the Simmons Law Firm. “This decision corrects that mistake, but comes too late for hundreds of the women already harmed by these dangerous drugs.”

The panel, comprised of independent medical experts, has also called for additional studies on birth controls to further evaluate drospirenone’s increased risk of causing blood clots that can result in serious medical events such as strokes, heart attacks and even death.

Preliminary findings of an FDA study released earlier this fall found women who use Yaz and other drospirenone pills were 74 percent more likely to experience serious side effects compared to women taking low-estrogen contraceptives. Other independent studies found a similar increased risk, while studies conducted by Bayer reported no increase of risk.

Drospirenone is a type of female sex hormone called a progestin, which is used in pills including Yaz and Yasmin. Millions of women switched to Yaz in 2008 after watching commercials touting Yaz’s ability to relieve symptoms associated with PMS. Those claims were later found to be exaggerated. The FDA fined Bayer AG $20 million and forced it to run corrective commercials.

The FDA panel reviewed six conflicting studies regarding drospirenone’s increased risk of causing blood clots, a condition called deep vein thrombosis. The clots most often occur in the leg or thigh. They can break loose and travel through the blood to other areas of the body like the lungs and trigger a pulmonary embolism. Severe symptoms of a PE include low blood oxygen, collapse and sudden death.

“This is a very serious health concern for women who have been negatively impacted by these drugs,” Miracle said. “These women and their families are asking a lot of questions, and the Simmons Firm is hoping to help them find the answers they deserve.”

Miracle is a member of the Yaz Multidistrict Litigation Steering Committee that manages thousands of federal Yaz and Yasmin lawsuits. The experienced pharmaceutical attorneys at the Simmons Firm are currently investigating claims against Yaz, Yasmin and other drospirenone-containing birth control pills.

About Simmons Browder Gianaris Angelides & Barnerd LLC

The Simmons Firm is a leading law firm in pharmaceutical litigation. The Simmons Firm has experience in litigating complex medical matters and has taken a leadership role in standing up for individuals who have been injured by dangerous or defective drugs. The firm has represented thousands of pharmaceutical clients and recovered more than $230 million in verdicts and settlements in cases involving Oxycontin, Vioxx and more. Learn more at

# # #

Share article on social media or email:

View article via:

Pdf Print