French watchdog criticizes new birth control pills over blood clot risk
A French watchdog has sharpened its attack on newer-generation contraceptive pills, demanding curbs on their use to help reduce the risk of dangerous blood clots.
The National Drugs Safety Agency (ANSM) says doctors are over-prescribing so-called 3rd and 4th generation birth-control pills, some of which are now the target of lawsuits and tighter guidelines in the United States.
Talks are being scheduled with medical associations over the pills, which are being taken by up to two million women in France, or roughly half of those taking oral contraceptives, the ANSM said on Tuesday.
“We are looking for a massive reduction in the consumption of these pills,” ANSM Director General Dominique Maraninchi told the media on Wednesday.
Doctors should only prescribe them “in very specific circumstances” and never as a first option, he said.
Maraninchi, whose agency has previously appealed for a return to using second-generation birth control pills, hinted at pulling products off the market if prescription numbers failed to fall fast enough.
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.
Thirty other women aged 17 to 48 are likely to file a suit by the end of January, targeting Schering, Merck and Pfizer as well as Bayer, her lawyer, Philippe Courtois, said last week.
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 female hormone progestogen, the idea being to skirt side-effects associated with older contraceptives.
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.
Last year the German pharmaceutical firm Bayer, which makes the Yasmin and Yaz contraceptives, said it had spent $750 million to settle nearly 3,500 lawsuits for alleged deep-vein thrombosis or pulmonary embolism.
An estimated 3,800 more lawsuits remain to be settled, as well as nearly 5,000 other claims over other types injuries allegedly caused by the pills.
In October, the US Food and Drug Administration (FDA) required Yasmin, Yaz and two other brands, Beyaz and Safyral, to carry labels saying there was a higher risk of clots compared with pills that do not contain the drospirenone version of progesterone.
The FDA stressed though any oral contraceptive boosts the risk of blood clots — and this risk “still remains lower” than when pregnant or giving birth.
The French government has already announced the country’s health system will no longer reimburse third- and fourth- generation pills, a measure that will take effect on September 30.
Veronique Sehier of France’s National Family Planning Office warned the controversy risked “demonising the Pill,” an opinion echoed by Brigitte Letombe, former head of the National Federation of Gynaecological Colleges.
Clotting and cardiac risks from taking the Pill are also influenced by smoking, obesity, diabetes and genes, said Letombe.