News Tagged ‘blood clots’
FDA panel member ‘well utilized’ by Yaz maker
A Food and Drug Administration (FDA) panel member who voted to keep the birth control pills Yaz and Yasmin on the market despite studies that showed the pills put women at greater risk for deadly blood clots was praised by the drugs’ maker Bayer in a 2008 report saying, “She will be well utilized.” The adviser, Paula Hillard, M.D., with Stanford’s School of Medicine, is listed on the medical school’s website as a paid consultant receiving $5,000 or more annually from a division of Bayer.
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
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which serves as a resource for policy makers and doctors, released several papers looking into the problem of unpublished trial data.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.
Women should be aware of blood clot risk with birth control pills, patches
FDA panel warns of elevated blood clot risk with patch, Yaz
A Food and Drug Administration (FDA) advisory panel said Friday that the Ortho Evra birth control patch, made by Johnson & Johnson, should remain on the market despite an elevated risk for blood clots. The panel voted 19-5 in favor of patch as an alternative contraceptive for women who are unable to take a daily birth control pill.





