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Posts Tagged ‘hormones’

Bayer Withheld Data on Birth Control Risks From US Regulators

Saturday, December 10th, 2011

An August investigation by FasterSkier staffer Chelsea Little into the effects of hormonal birth control on female athletic performance included accounts by several very successful domestic skiers about how the birth control pill Yaz had affected their training, racing, and general health. While many other forms of birth control were also discussed – and many of the issues pertaining to hormonal contraceptives are just as relevant to non-athletes – we wanted to present a brief follow-up of recent events.

Bloomberg recently reported that a former FDA commissioner claimed that Bayer, the maker of Yaz and Yasmin, a similar drug, had withheld internal research from U.S. regulators. In a 2004 report to the FDA, Bayer left out findings that Yasmin increased risk of venous thromboembolism, the life-threatening disorder which Kikkan Randall suffered from (although she did not take Yaz, instead using NuvaRing). Bloomberg wrote:

“In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.”

An initial draft of Bayer’s “white paper”, which documented internal research, reportedly included the following:

“When considering only serious AEs (adverse events), the reporting rate for Yasmin was 10 fold higher than with the other products.”

Bloomberg reported that Bayer is currently facing over 10,000 lawsuits over its contraceptive products, and at least 50 deaths have resulted from their use.