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Shezad Malik MD JD
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Yaz, Yasmin Blood Clots and the FDA

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This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing.

The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.

The FDA's Advisory Committee for Reproductive Health Drugs and a drug safety committee voted Friday to recommend that the FDA should allow the patch to remain a contraceptive option.

The same panel had voted 15-11 that the benefits of drospirenone-containing oral contraceptives such as Yaz and Yasmin outweigh the risk of venous thromboembolism (VTE).

Reproductive and drug safety experts advised the FDA to add stronger label warnings of Yaz and Yasmin blood clot risks, but decided not to recommend a Yasmin and Yaz recall.

The panel voted 21-5 to add new blood clot label warnings to drospirenone-based birth control pills, saying that the current warnings are vague, too confusing, and need to be updated with the most recent drug safety information.

One of the most recent reports examined by the committee was from the FDA itself, which found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. The panel noted that the FDA study did not account for smoking, obesity and some other health factors which could have played a part in its findings.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits, indicate that Former FDA Commissioner David Kessler believes that the company kept important safety data from federal regulators. Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on thromboembolic events to make the drugs appear to be safer than they really were. The testimony was barred from the committee hearing because it was not submitted in time.

The Ortho Evra patch, from Johnson & Johnson's Janssen, does not contain drospirenone, but it contains higher levels of estrogen than found in many common second-generation birth control pills (which contain lower doses of estrogen than the first-generation pills introduced in the 1960s).

An FDA postmarking report in October stated that the patch, the norelgestromin/estradiol vaginal ring, and birth control pills containing drospirenone, were all associated with increased risk for VTE, compared with hormonal contraceptives with relatively low doses of estrogen.

The panel addressed labeling on the patch, voting 20-3, that it should more clearly state the patch's risks and calling the current labeling confusing.

Janssen has changed its label three times since 2005 to update the risk of the patch, and earlier this year the FDA added a boxed warning saying that one study found the VTE risk was significantly greater with Ortho Evra than with lower-estrogen birth control pills.

The black box warning was meant to draw more attention to the risk of blood clots, according to Scott Monroe, MD, director of the FDA's Division of Reproductive and Urologic Products.

So what does all add up to? It means we have to slog through the bellwether trials that are scheduled for next year for both the Nuvaring and Yaz and Yasmin contraceptives. After they are played out, perhaps then these companies will come to the settlement table and compensate the thousands of women who have been horribly injured by these drugs.

Unfortunately the general public does not understand the risk associated with these drugs. They are not benign and they have a significant side effect profile and risk. These women need to understand that and the risk needs to be emphasized by their doctors. But sadly it is not. And in fact most doctors do not have that discussion with their patients. A lot of refills are filled automatically and the game of Russian Roulette continues.

The FDA could have done the right thing but sadly it abrogated its regulatory role to the powerful business interests and lobbyists at the hearing. Business as usual at the FDA, with its revolving door and life goes on Washington, except it does not for the women who have died as a side effect of these drugs. I will light a candle for you and your families, and you are in my prayers this Holiday Season.