Quoted from http://www.businessweek.com/news/2011-12-12/bayer-birth-control-pill-benefits-outweigh-risks-panel-says.html
Bayer Birth Control Pill Benefits Outweigh Risks, Panel SaysDecember 12, 2011, 2:07 PM EST
By Anna Edney
Dec. 8 (Bloomberg) -- Bayer AG’s Yaz and other birth control pills containing the hormone drospirenone won the backing in a close vote of advisers to the U.S. Food and Drug Administration examining whether the products increase the danger of blood clots.
The FDA panel today also recommended the pills’ labels be changed to better reflect the risk of potential blood clots from the oral contraceptives. Labels now inform women of conflicting studies on the hazards. The FDA isn’t required to follow the panels’ advice.
Studies have shown conflicting evidence about whether women who take the pills have a higher risk of blood clots than if they take older birth control pills that don’t contain drospirenone. Those ambiguous results prompted the FDA to ask for the review at the panel meeting today in Adelphi, Maryland.
“All of these studies have significant strengths and weaknesses,” said Julia Johnson, acting chairwoman of the panel and chair of the University of Massachusetts Medical School Department of Obstetrics and Gynecology.
Panel members were concerned that the results may have been affected by factors that weren’t studied such as women’s body mass index, smoking habits, family history and ethnicity, Johnson said.