News Tagged ‘drospirenone’
Yaz lawyers oppose former FDA chief’s testimony
Drug giant Bayer is not at all happy that a former Food and Drug Administration (FDA) chief has been tapped to testify against the drug company in a multidistrict litigation (MDL) focusing on the safety of Bayer’s top-selling birth control pills, Yaz. Former FDA commissioner Dr. David Kessler recently submitted an expert report claiming that an FDA advisory committee vote on the pills was tainted because some members of the panel were paid consultants for Bayer and posed an obvious conflict of interest.
Drug company ‘check lists’ influence patient choice
Watchdog group pushes FDA panel to revote on Yaz safety
First Yaz trial will be April 30 if mediation fails
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.
FDA panel members had ties to Yaz maker
Last month, an advisory panel for the Food and Drug Administration (FDA) pored over data that showed women who took birth control pills containing the hormone drospirenone were at greater risk of developing blood clots than women on older generation birth control pills. Yet, panel members refused to ban the drug, instead recommending that the FDA put stronger warnings on the pills’ labels. Why would the panel have such lax standards when it comes to the safety of American women? One watchdog group is suggesting that the panel, which included four advisers with ties to companies that make drospirenone-containing drugs, may have been unfairly slanted.
Combined birth control pills provide limited PMS pain improvement
First Yaz lawsuit ordered to mediation for potential settlement
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.
No breastfeeding plus birth control pills may increase risk of breast cancer
Drug companies may delay, withhold trial data from medical journals
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.





