France suspends acne drug used as contraceptive (Update)

January 27, 2013 by Richard Ingham

In the latest health scare to erupt in France, a drug watchdog on Wednesday announced it was suspending sales of an acne pill also used as a contraceptive after four women died and more than 100 others fell ill with blood clots.

The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35, which is prescribed to 315,000 women in France.

The move will be phased in over three months to allow users to find an alternative drug, Dominique Maraninchi, the agency's director, told a press conference.

The product, made by the German firm Bayer, is authorised for treating acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, he said.

"This drug is not licensed for use as a contraceptive," Maraninchi said.

"But it is being used as such, in this secondary role... yet there are plenty of other alternative contraceptives that can be used in this country."

Maraninchi said the agency had also carried out a benefit-versus-risk assessment for Diane-35 on the basis of its use as an acne treatment.

The assessment was negative, which explains why the drug is being suspended from the French market, he said.

Diane-35 is sold in 116 countries around the world, according to the ANSM website.

Over 25 years, four women have died and 125 fallen ill from blood clots attributed to Diane-35 or its generics, the ANSM said on Sunday.

Bayer, in an emailed statement to AFP on Sunday, said the risk of clots "is a known effect, and is clearly marked as such in the package advice for patients."

It added that Diane-35 should only be prescribed for acne, and "in the context of a medical consultation, with respect for appropriate use, side effects and precaution."

In a separate French-language statement Bayer underscored that Diane-35 has been on the market for more than 25 years and "has never been subject to a withdrawal of marketing authorisation for security reasons.

"As far as we know, no new scientific proof exists that would lead to a modification of the benefit-versus-risk assessment of Diane 35," the statement added.

France has been shaken by a series of health scares in recent years.

It has asked the European Medicines Agency (EMA) to change prescription guidelines for so-called third- and fourth-generation oral contraceptives after these drugs were found to carry a higher risk of blood clots compared to earlier versions.

In 2010, the French authorities censured breast implant manufacturer Poly Implant Prothese (PIP) after it was found to be using non-authorised silicone gel that caused a high rate of implant ruptures. Health experts disagree on the risks, though.

Another scandal concerns an anti-diabetes drug called Mediator, manufactured by the French pharmaceutical company Servier, which started being used as a slimming aid because it reduces hunger pangs.

The drug was pulled off the market in 2009 after evidence emerged of hundreds of deaths caused by damage to heart valves.

Explore further: France at odds with European medicines agency over Pill (Update)

Related Stories

France at odds with European medicines agency over Pill (Update)

January 3, 2013
France insisted Friday on restricting the prescription of newer-generation birth control pills even as Europe's medicines watchdog declared there was no evidence to back a health warning.

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.

Some 8,000 French women have faulty breast implants removed

June 4, 2012
French health authorities said Monday that nearly 8,000 French women had followed a government recommendation to have faulty breast implants that sparked a global health scare removed.

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 ties newer birth control drugs to blood clots

October 27, 2011
(AP) -- Safety concerns with the popular birth control pill Yaz increased Thursday as federal health scientists reported that the Bayer drug and other newer birth control treatments appear to increase the risk of dangerous ...

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.