Special Segment: Birth Control Concerns

December 10, 2009 (CHICAGO)

While all birth control pills can have side effects, some patients, lawyers and researchers claim Yaz , Yasmin and the generic Ocella are even more likely to cause dangerous problems.

But most doctors don't agree, and they're more than comfortable writing prescriptions.

Patient Evangeline Semark Lemoine is coping with frustration. She says until about a year ago, she was a healthy person. But now, even simple activities with her family can be challenging.

"I don't have the carefree lifestyle that I had," she said.

The 32-year-old mom says she's now on a powerful blood thinner after developing a dangerous blood clot called a deep vein thrombosis in her leg.

Evangeline says it left her unable to walk, and after a phone call, resulted in her doctor advising her to get to an emergency room.

"The first thing out of her mouth was, 'Are you on a birth control pill?" and I said, 'Yes,' and she said, 'You need to get to the ER right now.'"

Lemoine, now a plaintiff, and her attorney say dangerous clots were also found in her lungs. They're suing Bayer Healthcare Pharmaceuticals and Teva Pharmaceutical Industries, blaming her health problems on the birth control pill Ocella, which is the generic form of Yasmin.

In a more extreme case, Susan Galinis claims, after being on Yaz, she had a stroke so severe that surgeons had to remove part of her skull because of swelling.

She too is suing Bayer, which also makes Yaz.

"If there is anyway we can force Bayer to take this drug off the market, we're going to do it," said Atty. Mike Danko.

There have always been risks associated with birth control pills, which use hormones to prevent ovulation. But, lawsuits are now piling up against Bayer with claims that Yaz and Yasmin carry a greater risk for health problems than some of the older oral contraceptives.

Some cases claim the culprit is a newer form of progestin, called drospirenone. It acts as a diuretic because it can increase potassium levels. Bayer does warn it should not be used by women with liver or kidney disease.

Lawsuit's claim Bayer is understating the risks.

"It says there is a risk, but the amount of the risk is not as clear as it should be to women taking this pill," said Atty. Jamie Goldstein, Gary Mcallister Associates.

Research recently published in the British Medical Journal did show a higher risk of blood clots for women taking newer progestins, including drospirenone.

But many women and doctors believe in Yasmin and Yaz.

Bayer and the Food and Drug Administration cite other studies, two funded by Bayer, that show no increased risk with Yaz or Yasmin. Yaz is even approved to help clear up acne and treat a severe form of PMS called PMDD.

"In a happy, healthy woman who has no other problems, this is a great contraceptive choice," said Dr. Barbara Soltes, OB-GYN, Rush University Medical Center.

Doctor Soltes was involved in the initial trials of Yasmin and Yaz. She says, right now, the pills are proven safe and do a great job at preventing pregnancy.

"I still think it is a safe pill," Soltes said.

In a written statement, Bayer says patient safety is its top priority and that its oral contraceptives are safe and effective when used according to the product labeling. Bayer stands behind the safety of its drospirenone-containing oral contraceptives.

The company says, as of October 15, it had received approximately 150 lawsuits, which it will defend vigorously.

"It incenses me that women are having these experiences," said Evangeline Lemoine.

She worries her life will never be the same, and she hopes her lawsuit will help others.

"I need to speak up and let other women know so that they might not have to go through what I went through," she said.

Earlier this year, the Food and Drug Administration asked Bayer to fix television commercials it claimed were over promising what Yaz could do. The company did so with a corrective advertising campaign.

The FDA says it is reviewing the safety of birth control pills with a study looking at the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives.

Bayer is also conducting its own study.

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