A consumer watchdog group is calling for a revote by a Food and Drug Administration (FDA) advisory panel, after discovering that some members of the panel had ties to drug companies that made the pills under review.
When Dr. Sidney Wolfe was asked in 2009 by the Food and Drug Administration (FDA) to join the agency’s Risk Management Advisory Committee for a 4-year term, the head of the Washington, DC-based watchdog group Public Citizen took the task to heart. He championed the removal of the longstanding painkiller Darvocet/Darvon, calling the drug “extremely dangerous” based on reports of more than 2,000 accidental deaths since 1981. He also pushed for stronger warnings on prescription drugs, including the type 2 diabetes drug Avandia, which has been linked to fatal heart attacks.
The first of more than 10,000 lawsuits against Bayer over its birth control pills Yaz and Yasmin won’t go to trial this week as planned because a judge appointed a mediator in hopes of settling the case. The lawsuit accused Bayer of misleading women about the safety risks associated with its oral contraceptives.
The recent recommendations from a Food and Drug Administration (FDA) advisory committee about safety concerns with contraceptives may make women more leery when deciding which birth control is best for them. But even for women who are currently on birth control, understanding the risks is vital.
Stronger warnings on packages of a newer class of birth control pills and government ruling to restrict the availability of the morning-after pill may make women leery of birth control in general, which could increase the rate of unwanted pregnancies or abortions, some advocacy groups warn.
Packs of Yaz and other birth control pills containing the hormone drospirenone should be updated to include a warning that the pills may be more likely to cause life threatening blood clots than older oral contraceptives, according to a Food and Drug Administration (FDA) advisory panel. The expert board was charged by the FDA with reviewing new data on the safety of the pills and recommending what action the federal agency should take.
Pharmaceutical manufacturer Bayer is facing thousands of lawsuits questioning the safety of its birth control pills Yaz and Yasmin. The pills, which contain a combination of drospirenone and ethinyl estradiol, have been found in studies to put women at greater risk for life threatening blood clots than oral contraceptives with other types of hormones. Both Yaz and Yasmin have generic equivalents, which leaves some women questioning whether generic brands are safer than the brand name drugs.
The doctor who pronounced 24-year-old Tania Hayes dead told her mother Genevieve twice that what caused Tania’s fatal blood clot was Yasmin birth control pills. “Tania wasn’t sick,” her mother told ABC News/Australia.
More women are choosing contraceptives such as IUDs and implants, according to a study published in the June issue of Obstetrics & Gynecology. Data shows that using these forms of reversible contraception increased from 2.4 percent in 2002 to 5.6 percent from 2006 to 2008. Public health experts say women are wooed by these types of contraception because they are highly effective and they can virtually be forgotten about once inserted. Alternatively, birth control pills, also known to be highly effective, have to be taken daily.
Two new studies showing an increased risk in venous thromboembolism (VTE), or blood clots in the lungs, in women who use Yaz birth control pills and oral contraceptives with similar hormone formulations, has resulted in a special drug safety notification from the Food and Drug Administration (FDA). Yaz, made by Bayer, contains the progestin drospirenone. The same hormone is used in Bayer’s Yasmin, Beyaz and Safyral, as well as generics such as Ocella, Gianvi, Loryna, Syeda, and Zarah.
