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FDA Requires Label Changes For The Patch

After cautiously clearing Yaz for continued use Thursday, an FDA Advisory Panel Friday addressed post-marketing data showing similarly increased blood clot risks among users of the contraceptive patch.  The committee, after having been clearly quite  extensively briefed,  heard testimony from Ortho Evra’s  manufacturer and experts in epidemiology, gynecology and hematology. They also heard moving testimony about  a young woman who died from a massive pulmonary embolism while using the Nuvaring, whose parents argued that not only the Patch, but most of the newer methods carry an increased clot risk that no woman should be allowed to take without being adequately informed.

The committee ruled that despite limitations of the data, the patch most likely carried a 1.5 times relative risk of blood clots compared to 2nd generation levonogestrel pills, but not necessarily higher than that of newer pills containing 3rd and 4th generation progestins and drosperinone.  With a few dissenters, the committee voted to allow the Patch to stay on the market, but asked for Read more »

*This blog post was originally published at The Blog That Ate Manhattan*

Considering The Risks And Benefits Of The Birth Control Pill

From a message posted on Facebook:

Is the pill safe? The International Agency for Research on Cancer in a 2007 study made by 21 scientists reported that the pill causes cancer, giving it the highest level of carcinogenicity, the same as cigarettes and asbestos. It also causes stroke, and significantly increases the risk of heart attacks. Several scientific journals have stated that the natural way of regulating births through the Billings Ovulation Method has no side-effects, and is 99.5 % effective.

The Billings Ovulation Method (BOM) is a method of natural family planning where women are taught to recognize when they have ovulated by examining their cervical mucus, allowing them to avoid intercourse during fertile periods or conversely, to have intercourse during fertile periods when pregnancy is desired. We used to call people who used the rhythm method “parents,” but BOM is more reliable than older abstinence methods.

I’m a big fan of oral contraceptives. They contributed to Read more »

*This blog post was originally published at Science-Based Medicine*

Yaz (An Oral Contraceptive Pill) And Blood Clots: What The “Higher Risk” Means

Two studies published in this weeks’ British Medical Journal, one from the US and the other from the UK, report that users of drosperinone containing oral contraceptives (Yaz, Yasmin and their generics) have increased relative risks for non-fatal blood clots compared with users of pills containing levonorgestrel.

While neither study is perfect, and indeed have some very major limitations, they add to a growing body of evidence that pills containing drosperinone may impart higher risks for blood clots than older pills. Yaz is not alone in this regard – other studies have suggested that pills containing the newer progestins gestodene and desogestrel also impart slightly high clot risks than the so-called first and second generation pills containing the older progestins norethindrone and levonorgestrel.

I won’t go into the studies’ limitations here, but will say that trying to get our hands around comparative data on clot risks between various pills is an extraordinarily difficult process given that the diagnosis of blood clots is not always straightforward (or correct), pill choices are not randomized and fraught with prescribing bias, and confounding risk factors for clotting are numerous and difficult to control for. I wish folks would stop trying to answer these questions on the quick and cheap using claims and pharmacy databases without requiring chart review and strict diagnostic criteria. But that’s the way these studies are being done, and that’s the data I am being forced to contend with in my practice, so let’s talk about it. Read more »

*This blog post was originally published at The Blog That Ate Manhattan*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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