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onehandle

(51,122 posts)
Wed Dec 18, 2013, 02:12 PM Dec 2013

Side Effects May Include Death: The Story Of The Biggest Advance In Birth Control Since The Pill

WASHINGTON -- In the summer of 2002, the pharmaceutical company Organon unveiled what it believed would be a game-changer in the multibillion-dollar birth control industry. Its product, NuvaRing, was the first hormonal contraceptive vaginal ring in the world. An easy-to-use device that relieved women of the burden of taking a pill on a daily basis, it was hailed as the greatest advance in contraception since the introduction of the pill in 1960.

"We've never seen anything like this in my lifetime," Dr. Carolyn Westhoff, a professor of obstetrics and gynecology who worked on NuvaRing's clinical trials, told Newsday that August. "It's really an exciting time for contraceptive users," Dr. David Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina, told The Washington Post. "It's a new era."

Before NuvaRing could be marketed in the United States, however, it needed the approval of the Food and Drug Administration, and the FDA had some concerns. Most hormonal contraceptives carry a risk of blood clots, with a higher risk of cardiovascular events among women who smoke, especially if they are over the age of 35. But in one of the clinical trials for NuvaRing, a healthy woman in her 20s had developed a blood clot -- a surprising occurrence that an investigator determined was probably related to the birth control device.

snip...

Today, NuvaRing is marketed in more than 50 countries, making it one of the most popular forms of birth control in the world. An estimated 1.5 million women use NuvaRing worldwide, and it has been prescribed more than 44 million times over the past decade in the U.S. alone. It is currently manufactured by the pharmaceutical giant Merck & Co., after Organon was acquired by Schering-Plough in 2007 and Schering-Plough merged with Merck in 2009. Last year, sales of NuvaRing generated $623 million globally, according to Merck's 2012 financial report.

http://www.huffingtonpost.com/2013/12/18/nuvaring-blood-clots_n_4461429.html

'Side Effects May Include Death' always perks up my ears in a big pharma commercial.

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