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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*

Pulmonary Embolism: If It Can Strike Serena Williams, It Can Ace Anyone

News that tennis star Serena Williams was treated for a blood clot in her lungs is shining the spotlight on a frightfully overlooked condition that can affect anyone — even a trained athlete who stays fit for a living.

Williams had a pulmonary embolism. That’s doctor speak for a blood clot that originally formed in the legs or elsewhere in the body but that eventually broke away, traveled through the bloodstream, and got stuck in a major artery feeding the lungs. (To read more about pulmonary embolism, check out this article from the Harvard Heart Letter.) Pulmonary embolism is serious trouble because it can prevent the lungs from oxygenating blood — about one in 12 people who have one die from it.

“No one is immune from pulmonary embolism, not even super athletes,” says Dr. Samuel Z. Goldhaber, professor of medicine at Harvard Medical School and one of the country’s leading experts in this clotting disorder.

Pulmonary embolism tends to happen among people who have recently had surgery, been injured, or been confined to bed rest for some time. It can also strike after long-haul flights.

Signs of a PE

How do you know if you’re experiencing a pulmonary embolism? The most common symptoms include shortness of breath when you aren’t exerting yourself, along with chest pain and coughing up blood. If you experience any of these symptoms, see a doctor immediately. Other worrisome signs include:

  • Excessive sweating
  • Clammy or bluish skin
  • Light-headedness
  • Fast or irregular heartbeat

The tennis star’s pulmonary embolism could have been the result of the perfect storm. After having a cast removed from a foot she cut at Wimbledon, Williams flew from New York to Los Angeles. It was in LA, after an appearance at the Oscars ceremony on Sunday, that she underwent emergency treatment at Cedars Sinai Hospital for a blood clot in her lungs.

A call to action by the U.S. Surgeon General says that pulmonary embolism and a related condition — deep-vein thrombosis — affect an estimated 350,000 to 600,000 Americans each year. Together, they account for somewhere between 100,000 and 180,000 deaths each year.

To learn more about pulmonary embolism, check out this information from the North American Thrombosis Forum.

- P.J. Skerrett, Editor, Harvard Heart Letter

*This blog post was originally published at Harvard Health Blog*

Regional Variations in Total Knee Replacement Surgery

It has been proven than there is tremendous variation in the practice of medicine across the United States. The Dartmouth data (Wennberg et al) has documented the differences in how medical resources are used and how different physicians practice medicine, depending upon where they live. The Dartmouth studies are mainly focused on cost and outcomes and make the case that improved quality is often inversely related to the cost of care. More (expensive) care is not necessarily better care.

Now that I am recovering from a total joint replacement, I am amazed to see the differences in how physicians, doing the same surgery, treat the patient. Total knee replacement (TKA) is one of the most common orthopedic procedures done today. Despite this, the patient cannot expect the same post op care. Read more »

*This blog post was originally published at EverythingHealth*

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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