French health estimates delve into Pill risk

March 26, 2013

A French drug watchdog on Tuesday released estimates for blood clots linked to birth control pills in the wake of fears that so-called third- and fourth-generation oral contraceptives boost a small risk of dangerous thrombosis.

Between 2000 and 2011, contraceptive pills were linked on average to 2,529 annual cases of blood clots, the National Agency for the Safety of Drugs and Health Products (ANSM) said.

Of the tally, 1,751 were attributable to third- and fourth generation pills, it said.

On average, 20 fatalities annually could be linked to contraceptive use, six of which could be attributed to first- and second-generation pills and 14 to the later-generation pills, the agency said.

"The risk of venous applies to the population as a whole, but the risk is low," the ANSM said in a press release.

"It increases with age for all women, regardless of whether they use or not. It is higher for users of third- and fourth-generation contraceptives than for users of first- and second-generation contraceptives," it said, reiterating an earlier judgement.

Clots that lodge in the veins can be highly dangerous, potentially causing strokes or heart attacks.

The ANSM estimates are based on a , not on an analysis of individual cases. Smoking and obesity are also associated with higher risk of clots.

More than four million women annually took oral contraceptives during the 2001-2011 period, roughly half of whom took first- and second-generation pills and the remainder third- and fourth-generation.

The third-generation Pill, introduced in the 1990s, and the fourth generation, approved in the last decade, are formulated to have synthetic versions of the progestogen, the idea being to skirt side-effects associated with older contraceptives.

In January, the called on doctors to prescribe third- and fourth-generation pills only "in very specific circumstances" and never as a first option.

It also urged the European Medicines Agency (EMA) to alter its guidelines accordingly. The EMA said on January 28 that it would study the request.

The health ministry also dropped the two later generations of the Pill from the list of medications that are reimbursed under France's national health-insurance programme.

The ANSM said that figures for February showed a slump in sales of 34 percent for third- and fourth-generation pills, and a rise of 27 percent for first- and second-generation alternatives, as women made the switch.

The storm in France has been triggered in part by the case of a 25-year-old woman, Marion Larat, who was left badly handicapped by a stroke that, in a lawsuit, she attributes to a later-generation pill made by Bayer.

A Danish study published in the British Medical Journal in 2011 found women who took one of the newer types of Pill ran twice the risk of developing venous thromboembolism compared to counterparts who used older-generation pills.

Compared with non-users of the Pill, the risk of a clot was between three and six times higher.

In absolute terms, though, the risk from the newer contraceptives was small, the investigators said.

Explore further: EU drug agency to review safety of new-generation Pill (Update)

Related Stories

EU drug agency to review safety of new-generation Pill (Update)

January 28, 2013
The European Medicines Agency (EMA) on Monday said it would review safety data for third- and fourth-generation birth control pills, responding to French concern that these contraceptives may cause dangerous blood clots.

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.

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 ...

France at odds with European medicines agency over Pill

January 11, 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 merit a health warning.

Study confirms some contraceptive pills more likely to cause blood clots

October 25, 2011
A study published in the British Medical Journal today confirms previous findings that certain oral contraceptive pills are more likely to cause serious blood clots (venous thromboembolism - VTE ) than others.

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

April 10, 2012
(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 ...

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

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 ...

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.