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FDA to Revisit Safety of New Birth Control Pills

Only after dozens of deaths and thousands of lawsuits has the Food and Drug Administration (FDA) decided to revisit the safety of newer versions of birth control pills.

The Associated Press is reporting that the FDA will conduct a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 9 to examine the increased risk of blood clots in newer versions of birth control pills such as Yaz, Yasmin, and the Ortho Evra patch.

There are currently more than 4,000 lawsuits pending against Bayer for its trendy new pills Yaz and Yasmin. These pills contain drospirenone, a newer chemical version of the female hormone, progesterone, which has certain side effects that are potentially more dangerous than other generations of pills. Specifically, drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pauses or bradycardia.

Thus far, more than 50 women have died from the pills. The most recent case involved Rebecca Bapp, 21, of Brownington, Vermont who called her parents from school on November 12 to say she was having trouble breathing and didn't feel well. They picked her up and took her to a nearby hospital where doctors were still trying to figure out what was wrong with her when she coded. They revived her twice before she coded again and this time, never came back. An autopsy later revealed that she died of a blood clot in the heart and the secondary cause of death was listed as "oral contraceptive."

As of last month, the Food and Drug Administration had received reports of 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins) and 229 of other blood clots for both Yaz and Yasmin.

The pills still remain on the market, despite the fact that two 2009 studies published in the British Medical Journal concluded that women taking these particular pills had a 6.3 times greater risk of developing blood clots.

Johnson & Johnson's Ortho Evra patch, which is changed weekly, will also be investigated. Although the patch uses a different version of progestin, it releases 60 percent more estrogen and progestin into the bloodstream than typical pills and is believed to have caused the death of 23 women. Independent studies have found that a woman’s risk of developing a blood clot while wearing the Ortho Evra birth control patch is approximately three times higher than when using an oral contraceptive. The most common side effects of the patch are severe blood clots, leading to heart attacks and strokes.

On Thursday, Cindy Rippee of Escondido, California will attend the meeting and will tell the FDA panel about her 20-year-old daughter, Elizabeth, who died Christmas Eve 2008 when a blood clot traveled to her lung. Rippee says her daughter had been taking Yasmin for about two months.

"I really feel that if my daughter had been told about the increased risk she would have made a different decision," she said.

Even though many believe the drugs should be recalled, the meetings are not expected to result in anything more than the addition of new warnings to the product labels.

Money is a big reason why more will not be done to protect young women from these dangerous drugs. According to IMS Health, the U.S. market for female contraceptives last year totaled $3.4 billion.

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