News Tagged ‘FDA warning

Yaz lawyers oppose former FDA chief’s testimony

lawsuit gavel scales of justice 100x100 Yaz lawyers oppose former FDA chiefs testimonyDrug 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.

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FDA panel member ‘well utilized’ by Yaz maker

bayer logo 100x100 FDA panel member well utilized by Yaz makerA 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.

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Watchdog group pushes FDA panel to revote on Yaz safety

POGO rs2 100x100 Watchdog group pushes FDA panel to revote on Yaz safetyA 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.

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First Yaz trial will be April 30 if mediation fails

lawsuit gavel scales of justice 100x100 First Yaz trial will be April 30 if mediation failsIf 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.

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FDA panel members had ties to Yaz maker

fda logo 100x100 FDA panel members had ties to Yaz makerLast 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.

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First Yaz lawsuit ordered to mediation for potential settlement

lawsuit gavel scales of justice 100x100 First Yaz lawsuit ordered to mediation for potential settlementThe 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.

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No breastfeeding plus birth control pills may increase risk of breast cancer

yaz pill pack 100x100 No breastfeeding plus birth control pills may increase risk of breast cancerWomen who use birth control pills and have never breastfed are at as great of a risk of developing breast cancer as women with a family history, according to a new study published in the Indian Journal of Cancer.

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Women should be aware of blood clot risk with birth control pills, patches

yasmin1 100x100 Women should be aware of blood clot risk with birth control pills, patchesThe 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.

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Birth control called ‘secondary cause of death’ in young woman taking Yaz

old yaz pack 300x225 Birth control called secondary cause of death in young woman taking YazIt was mere hours after Rebecca Bapp called her parents to say that she wasn’t feeling well that the 21-year-old was dead. Mysteriously, her health declined so rapidly even doctors were baffled by what was making her so ill. Not long after her parents rushed her to the hospital, she was placed on a breathing machine and sedated. She coded three times before she gave up her fight for life.

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Blood clot warnings on birth control pills could impact user rates

black box warning graphic WL 100x100 Blood clot warnings on birth control pills could impact user ratesStronger 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.

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