Certain birth control pills may carry higher blood clot risk: FDA

April 10, 2012 By Steven Reinberg, HealthDay Reporter
Certain birth control pills may carry higher blood clot risk: FDA
Products such as Yaz or Yasmin, containing drospirenone, will get new labels, agency says.

(HealthDay) -- U.S. health officials announced Tuesday that birth controls pills containing drospirenone -- a man-made version of the hormone progesterone -- may be associated with a higher risk of blood clots and will require new labels.

The U.S. Food and Drug Administration said the updated labels will inform users that the pills -- which include products such as Bayer's Yaz or Yasmin -- may carry as much as a tripled risk for blood clots compared to containing other types of progesterone (also called progestins) such as levonorgestrel.

The agency findings came from observational studies, some of which found increased risk for blood clots while others did not, the FDA noted in its alert.

The decision follows recommendations made in December by an FDA-appointed panel that several drospirenone-containing contraceptives carry revised labels warning about an increased risk of potentially fatal blood clots.

The FDA advisers had voted 21-5 in favor of new labels for the . These newer contraceptives have been successfully marketed on the premise that they have fewer of the unwanted side effects of older such as bloating, mood swings and acne.

Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City, told HealthDay in December that the risk of clotting with the newer pills is "a low risk but the risk exists. The idea of the FDA looking at this and potentially increasing the warning has no downside. If anything, it increases awareness and that can only be a good thing."

Previously, the panel members had voted that the newer contraceptives, which gained initial FDA approval in 2001, are a viable method of birth control, and that the benefits of preventing pregnancy outweigh the health risks.

Explore further: FDA favors more risk info on birth control pills

More information: The U.S. Department of Health and Human Services has more about birth control at womenshealth.gov.

Related Stories

FDA favors more risk info on birth control pills

December 6, 2011
(AP) -- Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed birth control pills such as Yaz, in light of growing evidence that the newer contraceptive ...

FDA revisits safety of newer birth control drugs

December 5, 2011
Birth control drugs that were heavily promoted as having fewer side effects and the ability to clear up acne and other hormonal bothers are under new scrutiny from safety regulators.

Some birth control shows higher clot risk: US

October 28, 2011
Some birth control products, including contraceptive pills, rings and patches for women, carry a significantly higher risk of blood clot than low-dose medications, US regulators said Thursday.

Drospirenone-containing contraceptives linked to higher risk of blood clots

November 7, 2011
The use of drospirenone-containing oral birth control pills is linked to a significantly higher risk of blood clots, both deep vein thrombosis and pulmonary embolism, according to an article in the Canadian Medical Association ...

FDA panel backs birth control patch despite risks

December 10, 2011
(AP) -- A panel of federal health advisers said Friday that a birth control patch from Johnson & Johnson probably carries a higher risk of blood clots than older drugs, but should remain available as an option for women ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.