Yaz, Yasmin, Ocella Side Effects Lawsuit News

Safety of birth-control pills under review

- The Columbus Dispatch

11/27/2011 - Concerns about an elevated risk of blood clots linked to certain birth-control pills will be discussed early next month by a Food and Drug Administration committee, which could recommend stronger warnings about potentially life-threatening problems.

At issue is the ingredient drospirenone, a form of progestin used in newer pills such as Yaz, Yasmin, Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi and Loryna.

In an effort to resolve conflicting results from previous research, an FDA-led study looked at 835,826 women and found a 74 percent higher incidence of clots for those who took the newer pills compared with those who took older types.

The risk of developing blood clots for all women who take birth-control pills is small overall: about 6 in 10,000, according to the FDA. The additional risk associated with the newer pills would put the number at about 10 in 10,000.

The analysis also found an elevated risk of heart attack and stroke for new users of the newer pills and an increased risk of clots in the legs or lung for women using a vaginal ring or birth-control patch.

On Dec. 8, the FDA committee will review the details of that study, after which they could recommend labeling changes.

The main concern is deep-vein thrombosis (a blood clot, usually in the lower leg or thigh) that breaks loose and leads to a pulmonary embolism, the potentially fatal blockage of an artery in the lung. Symptoms include persistent leg pain, severe chest pain and sudden shortness of breath.

Blood clots also can break loose and lead to strokes and heart attacks.

Emily Neffenger of Sunbury was looking forward to her June wedding when, two months before, she found herself in the bathroom in the middle of the night, unable to speak or open the door.

“The left half of my body was completely numb,” she said. “I sat down and didn’t know what to do. I couldn’t get out of the bathroom and I couldn’t talk. I was just kind of making noises.”

Alex, who is now her husband, found her there and called paramedics. Neffenger, 27, had had a mild stroke.

Eventually, doctors determined that Neffenger has a disorder that makes her prone to blood clots. But she also had been on Yaz, or a generic form, for several years.

Neffenger said doctors should be careful when prescribing birth-control pills and go over all the potential risks. She’d like to see routine testing for clotting problems.

Although blood tests are unlikely to become the norm, doctors can and should be careful to ask women about a family history of clotting and talk about other things that put women at higher risk, including smoking and obesity, said Dr. Geoffrey Eubank, a neurologist and director of Riverside Methodist Hospital’s stroke program.

In addition to learning about the risks associated with birth-control pills in general, women who have a known risk of clotting should have serious discussions with their doctors, he said.

“I think, like every decision, you kind of have to weigh the reasons you are using them against the risk,” he said.

Dr. Lisa Keder, associate professor of obstetrics and gynecology at Ohio State University Medical Center, said she has not been recommending against Yaz and similar pills because studies have shown mixed results and the risks overall are relatively low.

“If you double a rare thing, it’s still a rare thing,” she said.

And it’s important to remember that pregnancy carries an elevated risk of blood clots — about 30 incidents per 10,000 pregnant women — as well, she said.

Women who are concerned about their pills should not stop taking them without talking to their doctors, Keder said. Unintended pregnancy is a serious consideration when women who do not wish to have babies stop their birth control.

Women also should have educated discussions with their doctors about the best pill for them, Keder said. In general, she doesn’t think that Yaz and similar pills have an advantage over older pills.

Bayer, the maker of Yaz, has said that company leaders believe the clotting risks are similar to those associated with other birth-control pills and are working closely with the FDA to evaluate its study.

Yaz / Yasmin / Ocella Lawsuit News Archive::

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Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.