RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy

New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy

Posted 10 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) issued an updated safety warning 10 April about birth control products containing drospirenone-a synthetic version of the hormone progesterone-saying the hormone may be associated with a higher risk for blood clots than other progesterone-based pills.

Some studies highlighted by FDA showed a three-fold increase in the risk of developing a blood clot, though FDA admitted "it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills."

"The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not," said FDA in a statement. "The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots." 

FDA noted some birth control products, including Beyaz and Yasmin will require revised drug labels.

The products were recently the subject of a Wall Street Journal investigation, which found that the advisory committee advising FDA on the product's safety had among its members at least three members with existing financial ties to Bayer, the drug's manufacturer.

The Journal's report unleashed a torrent of criticism from groups like the Project on Government Oversight, which asked FDA Commissioner Margaret Hamburg to investigate.

FDA soon fired back at mounting criticism, saying that critics exhibited a "lack of understanding about our selection and evaluation process."

The issue has mostly laid dormant since late January, but FDA's notice of increased risks associated with the drospirenone products is likely to bring the issue back into focus.

Read more:

FDA - FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

Regulatory Focus - WSJ: Panel Assessing Bayer Birth Control Pills Had Ties to Company

Regulatory Focus - POGO Lambastes FDA Over Conflict of Interest Report

Regulatory Focus - FDA Responds to Conflict of Interest Uproar

Regulatory Focus newsletters

All the biggest regulatory news and happenings.