If mediation fails between Bayer and lawyers for the defendant, the first Yaz/Yasmin trial against the drug company will start on April 30. U.S. District Judge David Herndon ordered the mediation earlier this month in an attempt to settle the mounting lawsuits. But in a Jan. 10th clarification of a Dec. 31st order, he warned that if Bayer and plaintiffs don’t act in good faith, he would remand cases to districts where they began.
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.
Missing data from clinical trials that test the safety and efficacy of pharmaceutical drugs “distorts scientific record” and puts patients lives in danger, the British Medical Journal warns. The medical publication, which serves as a resource for policy makers and doctors, released several papers looking into the problem of unpublished trial data. One study from Yale University found that fewer than half of the 635 National Institutes of Health-funded trials were published in peer-reviewed medical journals within 30 months of trial completion. This includes experimental drugs as well as those already licensed on the market.
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.
A new study backs up concerns of previous studies that show birth control pills containing the hormone drospirenone, such as Yaz and Yasmin, are more likely to cause deadly blood clots than oral contraceptives made with older generation hormones.
Yaz, and other birth control pills made with the hormone drospirenone, have been shown in studies to put women at greater risk for developing deadly blood clots, yet generic versions of the drug are still being approved for sale in the United States. Watson Pharmaceuticals Inc. has just been granted approval by the Food and Drug Administration (FDA) for Vestura, its generic version of Bayer’s Yaz.
Bayer didn’t want anyone to find out its top-selling birth control pill Yasmin could be more dangerous than older oral contraceptives, and even went so far as to promote the pill for uses for which it had not been approved, according to a Food and Drug Administration (FDA) report unsealed in federal court last week.
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.
Women who recently gave birth and are older than 34 or who have had a C-section should not take oral contraceptives that contain estrogen, according to researchers with the Centers for Disease Control and Prevention (CDC). Studies show the pills could increase the risk of older women developing blood clots if taken within six weeks after delivering a baby. Blood clots, if they travel to the brain or lungs, can cause strokes, respiratory problems, and even death. All new mothers, regardless of age, are also advised not to take estrogen-containing oral contraceptives in the first three weeks following delivery.
