US reviews birth control pill safety over clot risk

May 31, 2011

The US Food and Drug Administration said Tuesday it is reviewing recently published studies which have pointed to an increased blood clot risk associated with a certain type of birth control pill.

The studies involve pills that contain drospirenone, as opposed to another type of progestin known as . Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.

"The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills," it said in a statement.

"FDA will continue to communicate any new safety information to the public as it becomes available."

The European Medicines Agency concluded on May 27 that such birth control pills carry a higher risk of venous thromboembolism and that should be updated accordingly.

However it noted the overall risk of blood clot from any birth control method remains small and stopped short of advising women to stop taking pills containing drospirenone.

The pills have been the focus of numerous lawsuits, including one lodged earlier this month on behalf of a teenager who died from a blood clot allegedly linked to the German chemical and pharmaceutical company Bayer's Yaz contraceptive.

Michelle Pfleger, an 18-year-old college student in North Carolina, died of cardiac arrest last September after taking YAZ, also known as Yasmin or Ocella, to treat acne, according to the complaint.

Last month, two studies in the found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier-generation .

Bayer criticized the results of the studies at the time, insisting that side effects were rare.

The official Yaz website says the drug is associated with "increased risks of several serious side effects, including blood clots, stroke, and heart attack."

Explore further: FDA warns of compounded drug recall by Texas firm

add to favorites email to friend print save as pdf

Related Stories

New warning OK'd for birth control patch

Jan 21, 2008

The U.S. Food and Drug Administration has approved a warning for the Ortho Evra Contraceptive Transdermal Patch label concerning the risk of blood clots.

Non-prescription pills draws controversy

Feb 05, 2007

A new plan in Britain that would allow birth control pills to be available for sale without prescription has some area doctors concerned, a report said.

Recommended for you

EU regulator: Morning-after pill OK for all women

1 hour ago

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

6 hours ago

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

Zydelig approved for three types of blood cancer

6 hours ago

(HealthDay)—Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) ...

Journal raises concern about blood-thinning drug

19 hours ago

A medical journal raised concerns Wednesday about a blood-thinning drug widely used by people at risk of stroke, accusing its manufacturer of concealing safety data and regulators of laxness.

User comments : 0