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

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

Restasis: Why US consumers paid billions for drug deemed ineffective in other countries

January 2, 2018
Why are Americans, both as patients and taxpayers, paying billions of dollars for a drug whose efficacy is so questionable that it's not approved in the European Union, Australia or New Zealand? Restasis, a blockbuster drug ...

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.