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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*

Vitamin D Associated With A Higher Risk Of Atrial Fibrillation

Too much vitamin D can lead to 2.5 times the risk of atrial fibrillation, researchers found.

To determine if there is a correlation between too much vitamin D and increased heart risk, researchers examined blood tests from 132,000 patients in the Intermountain Healthcare Center database. Results were presented at the American Heart Association Scientific Sessions in November, and appeared at the Intermountain website.

Patients did not have any known history of atrial fibrillation, and all had previously received a vitamin D assessment as part of their routine care. Patients were then placed into categories to compare levels of vitamin D: low (less than 20 ng/dL), low/normal (21-40 ng/dL), normal (41-80 ng/dL), high/normal (81-100 ng/dL), and excess (more than 100 ng/dL).

Patients with low, low-normal, normal and high-normal levels of vitamin D had no increased risk of atrial fibrillation. However, atrial fibrillation risk Read more »

*This blog post was originally published at ACP Hospitalist*

Guidelines For The Treatment And Prevention Of Frostbite

Led by Scott McIntosh, MD and his colleagues, the Wilderness Medical Society has published “Practice Guidelines for the Prevention and Treatment of Frostbite” (Wild Environ Med 2011:22;156-166). These guidelines are intended to provide clinicians about best evidence-based practices, and were derived from the deliberations of an expert panel, of which I was a member. The guidelines present the main prophylactic and therapeutic modalities for frostbite and provide recommendations for their roles in patient management. The guidelines also provide suggested approaches to prevention and management of each disorder that incorporate the recommendations.

In outline format, here is what can be found in these guidelines: Read more »

This post, Guidelines For The Treatment And Prevention Of Frostbite, was originally published on Healthine.com by Paul Auerbach, M.D..

Doctors Fail To Disclose Evidence About Spine Product’s Cancer Risk

Reporter John Fauber has published the latest in his “Side Effects” watchdog series, headlined “Doctors didn’t disclose spine product cancer risk in journal: Spine-product paper omitted key data.” Excerpts:

“Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company’s spine surgery product in a 2009 paper about results of a large clinical trial.

The surgeons left out important data and claimed there was no significant link between the product and cancer.

The company and doctors had become aware of information on Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Women At Higher Risk Of Having A Stroke With Afib

You don’t want this…

When it comes to the risk of stroke in atrial fibrillation, it pays to be a boy. Sorry, ladies.

An important question came up on my recent post on AF and stroke.

Why does being female give you an automatic point on CHADS2-VASc?  I keep seeing it, but I don’t see why that is.

It doesn’t seem intuitive that female AF patients should have more strokes. Why? AF should equal AF.

But it does matter. When it comes to AF and stroke, women are very different.

Here are three references that support the fact that female gender increases the risk of stroke in AF.

–First: Read more »

*This blog post was originally published at Dr John M*

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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