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New Birth Control Labels Detail Increased Risk For Blood Clots

April 11, 2012

The US Food and Drug Administration (FDA) has begun to add information to labels of popular birth control medications to warn about the increased risk of blood clots.

Bayer AG´s “Yaz” or Yasmin is one of the medications receiving the new label, though all common types of birth control pills increase a woman´s risk of potentially fatal blood clots.

The FDA is following up new studies with these labels, saying certain forms of birth control like Yaz show an even higher increase for blood clots. Yaz contains a synthetic hormone known as drospirenone which has been shown to increase the potential for blood clots.

In a statement, the FDA said, “The revised drug labels will report that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products “¦ whereas other epidemiological studies found no additional risk.”

In their own study, the FDA found 10 in every 10,000 taking pills with drospirenone would get one blood clot per year, compared to only 6 in 10,000 women. These blood clots become fatal if they break loose and travel up to the brain, heart, or lungs.

Despite these risks, women may still be on the safe side by taking the pills; The FDA noted women who become pregnant are even more likely to get these blood clots.

This announcement follows a decision made in December to revise the labels of pills containing drospirenone. An advisory committee of experts to the FDA made the decision in order to give clearer information about these pills. Some of the tests, however, did not conclusively show an increase of blood clots in women taking these pills. Therefore, these experts stopped short of declaring the risks of taking these pills outweighed their benefits.

A change in the label is a good step forward for some, though others are saying this action isn´t enough to fully protect women.

During the December meeting to determine these new labels, some women´s advocacy groups called for the pills to be taken off the market. To make their point, these advocacy groups, along with patients told stories of sudden-deaths or life changing disabilities experienced by themselves of loved ones who were taking Yaz or Yasmin.

Yaz is a reformulated version of Yasmin, and is one of America´s top selling contraceptive medications. Owner Bayer sold $374 million worth of Yaz in 2010, according to data from IMS Health. The recent introduction of generics have cut into sales of Yaz, however.

Executive director of the National Women´s Health Network, Cynthia Pearson, testified at the December meeting, saying simply changing the label will not protect women from these blood clots.

“I fear that if the FDA holds another public hearing three years from now, there will be a new group of women telling sad stories about the harm done to their health by clots,” she told the Chicago Tribune.

Women who take any type of birth control medication have an increased risk of blood clots, particularly as they get older.

US Health authorities have ordered the labels of some types of birth control to be revised, including Bayer´s “Yaz”. The revised labels are to advise users of a higher risk of blood clots.

A new label for Yaz has already appeared on the FDA website, and says, “Women who use birth control pills with drospirenone (like Yaz) may have a higher risk of getting a blood clot.

Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone.”

The FDA did mention, however, there were mixed results in these studies.

In a statement, the FDA said, “The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.”

“The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots,” it added.


Source: RedOrbit Staff & Wire Reports



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