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FDA Warning About Birth Control Yaz
Updated May 5, 2013 12:10 AM | Filed under: WBIW News
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(INDIANAPOLIS)(WTHR13) - It was one the best selling birth control pills on the market. But now, a warning for women.

Fifty patients have reportedly died from taking the contraceptive and thousands of others say it causes potentially life-threatening side effects, prompting a trusted drug maker to spend millions to highlight the risks.

Linda Rosenberg was the picture of a healthy baby. She recalls growing up on Bayer Baby Aspirin and planned to care for her own baby in the same way, someday.

In 2007, motherhood was still in the future when her doctor told her about Yaz, a new oral contraceptive manufactured by Bayer. It was sweeping the country with a flashy ad campaign.

"There was no reason to believe the product was, you know, that there was any danger in taking it," explained Rosenberg.

But two years after taking daily doses of Yaz, Linda began experiencing unexplainable swelling. At her doctor's urging, she got an ultrasound. It probably saved her life. A blood clot was discovered in her ankle.

"Yes and right behind my knee, which was causing the swelling in the ankle," she told 13 Investigates.

Linda went through 18 months of treatment. But along the way, she lost more than she could have imagined.

"Now, I can't have children," she revealed.

The treatment for the blood clot left her unable to conceive children and her trust in a childhood name was gone. Rosenberg is now among hundreds of women nationwide blaming Bayer's Yaz birth control for devastating health effects.

"Had that blood clot traveled, you know, to her heart, her chest, she could have faced a pulmonary embolism, she could have had a heart attack. Had it gone to her brain, she could have suffered from a stroke. So she was very lucky," said Takeen Thompson, Linda's Indianapolis attorney.

"I'd like to see it off the shelves, if it's not safe," Linda insists.

"It doesn't happen just with Yaz," according Dr. Sara Sayger.

Sayger has prescribed Yaz as the medical director at the Purdue Health Center and Women's Clinic in West Lafayette. In fact, Sayger concludes all oral contraceptives come with some risk.

"Blood clotting is an uncommon side effect. A real danger, but an uncommon side effect," she said.

But according to lawsuits nationwide, Yaz is being blamed for the deaths of at least 50 women, including young college students.

Thompson told 13 Investigates her research reveals "most of the clients with the gall bladder disease were in their early 20s or so. (They) felt symptoms of having a heart attack and went into the doctor or hospital and learned that their gall bladders were not functioning properly and had to have them removed through emergency surgery."

Thompson is now representing Linda and other women suing the drug maker. At issue is Bayer's use of a new ingredient.

"We're talking about a progestin that had not been used in birth control pills," Thompson explained.

Dr. Sayger confirms the new ingredient.

"We've seen a couple of new synthetic progesterones that have come onto the market. Yaz is one of those new synthetic progesterones," she said.

Sayger describes Yaz as a "niche" contraceptive and evaluates closely whether it's a good fit for each patient.

"It's a pill that's been very positively received by women who have been on other products and still had very extreme emotional, premenstrual mood swings. Yaz seemed to be a good answer for those people" she found in her practice.

But Sayger agrees it's not for everyone.

In 2008, the FDA sent Bayer a warning letter regarding its advertising for Yaz. The FDA took issue with claims by Yaz to treat PMS and acne of all severities, even though Yaz had not been evaluated to do such.

The FDA also said "Yaz has additional risks because it contains the progestin, Drospirenone...which may result in potentially serious heart and health problems" in high risk patients.

The FDA said Bayer knew about the risks, the information came from the company's own studies. Yet it's warning labels failed to adequately disclose the potential danger.

"It does appear that they concealed that information," Thompson said.

Bayer declined an on-camera interview with 13 Investigates about Yaz, but in a released statement said "..the benefits...outweigh the potential risks" and that "labels...do not adequately reflect the risk...and should be revised to include additional information from available studies."

Bayer is now airing corrective ads.

Sayger points out that the FDA shares responsibility to ensure products for women are safe and wants to see more studies.

"Birth control pills have been on the market for 50-plus years. We now have three or four generations of pill users, so we have lots of experience with birth control pills," Sayger said.

But it's too late for Linda Rosenberg.

"Had I known that it could have been an issue, or a problem, I certainly would have not chosen to go that route," she said, hoping to warn other women.

The FDA did not take Yaz off the market.

Sayger says fewer college students are using that contraceptive, but for other reasons. She says Yaz costs around $70 a month, compared to other brands that range from $9 to $20.

Bayer is facing 10,000 lawsuits surrounding its Yaz and Yasmin birth control.

Read the FDA warning letter about Yaz.



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