France’s health and drug safety agency has said it is weighing the possibility of restricting certain types of contraceptive pills amid mounting fears over unwanted side effects, including stroke, following a high-profile lawsuit.
France’s national health and drug safety agency, the ANSM, is exploring the possibility of restricting the use of certain types of contraceptive pills amid growing public alarm over unwanted side effects.
Controversy over more recent versions of the pill began in France in mid-December when Marion Larat, 25, filed a lawsuit against both the multinational pharmaceutical company Bayer and ANSM’s general director after she suffered a debilitating stroke while taking the contraceptive pill Meliane.
While all oral contraceptives carry a warning about the risk of blood clots, a number of studies have found that more recent versions, such as Meliane, carry a higher risk than their predecessors. The European Medicines Agency has supported these findings, saying that the risk of forming an embolism is twice as high in women who use what are known as third- and fourth-generation pills.
A life turned upside down
Larat, by her own account, was a promising student with high hopes of attending one of the country’s top business schools, when her life was suddenly turned upside down in June, 2006. Unbeknownst to the then 18-year-old Larat, a clot had formed in her brain, eventually resulting in a massive stroke. After three days in a coma, Larat awoke to a harsh new reality. The next several months saw her undergo intensive physiotherapy and nine different surgeries.
Suspicions that the stroke was directly linked to Meliane were confirmed by an inquiry in June 2012, which found that the attack had taken place within three months after Larat was first prescribed the pill.
Now, nearly seven years after the stroke, Larat remains severely disabled. Her right hand, which she once used for day-to-day tasks such as writing, is no longer functional, and her ability to walk or speak is laboured.
Fear over the pill
Larat’s story quickly attracted widespread media attention in France, and just two weeks after filing her case, her lawyers announced on Saturday, December 29, that 30 other women had come forward with similar lawsuits.
As public concern over the safety of more recent versions of contraceptive pills grew, France’s government announced on Thursday that it would cease to reimburse prescription costs of third-generation pills as of March 31, instead of at the end of September as previously planned. The ANSM has also launched an inquiry reviewing health care professionals’ prescription practices, which the agency said may be responsible for the over-use of third and fourth-generation pills, despite previous warnings of possible health risks.
The ANSM also said that it was considering restricting the use of third-generation pills to only certain specialist doctors.
The government and ANSM’s reactions, however, has alarmed some who fear that in trying to resolve one public health concern, officials may be creating another.
“The general panic over this story has created a media frenzy, which could scare women from using the pill. It’s dangerous because the one major risk from all of this could be an explosion in unwanted pregnancies and abortions,” Dr. Joelle Tort-Grumbach, a Paris-based obstetrician-gynecologist, told FRANCE 24.
“I’ve already had two patients this week who have asked me if their pill is dangerous, and whether or not they should stop taking it,” Dr. Tort-Grumbach said, adding that cases like Larat’s are extremely rare. According to France’s ministry of health and social affairs, only 3-4 percent of women who use third or fourth generation pills suffer from the unwanted side effect of blood clots.
‘We have to stop demonising the pill’
While other women’s reproductive health specialists have agreed that it is important to raise awareness over the risks linked to third and fourth-generation pills, they’ve also highlighted the importance of contextualising the information.
“There’s not a single medication on the market that comes with zero risk,” Nathalie Bajos, a contraception expert at France’s National Health and Medical Research Institute, told FRANCE 24. “Even a commonplace medicine like paracetamol can lead to complications. We have to stop demonising the pill.”
For Bajos, the decision to no longer reimburse third generation pills amounts to nothing short of folly.
“There are a number of women who can’t take first or second-generation pills for whom the newer generations are better,” Bajos said, adding that women need to be better informed about all the different forms of contraception available to them. “There are very few gynecologists who present their patients with alternatives to the pill, such as IUDs [an intrauterine device], which is a very safe and effective birth control.”
Family Planning, a member organisation of the International Planned Parenthood Federation, also weighed in on the debate, issuing a statement earlier in the month criticising the government’s “ambiguous” reaction to the controversy.
“Either this generation of pills is dangerous and should be recalled from the market, or they are not… and therefore should be accessible to everyone and reimbursable. We need a clear, coherent and reassuring position on the issue,” the organisation said.
The group also called for health care professionals to be better trained on all the different forms of contraception, as well a comprehensive public awareness campaign to inform people of their options.
Date created : 2013-01-04