Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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.

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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which serves as a resource for policy makers and doctors, released several papers looking into the problem of unpublished trial data.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.

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For centuries, nuns have been at greater risk for developing breast, ovarian and uterine cancers – diseases that are more common in women who do not have children. But a new study published in The Lancet suggests nuns could greatly reduce their risk of these deadly cancers if they started taking birth control pills.

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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.

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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.

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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.

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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.

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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.

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Sid Wolfe, head of the Public Citizen Health Research Group, was stripped of his voting rights on a Food and Drug Administration (FDA) advisory panel just before the committee was to review the safety of the popular birth control pills Yaz and Yasmin. Wolfe’s consumer advocacy group has waged a campaign warning women about what it perceives to be the dangerous risk of blood clots with oral contraceptives containing the hormone drospirenone, such as Yaz and Yasmin.

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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.

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