PARIS |
Thu Jan 3, 2013 10:52am EST
PARIS (Reuters) – French health regulators are study tying a use of preventive pills that lift health risks and will stop reimbursing medication costs of some forms from March, after a lady sued drugmaker Bayer over purported side-effects.
An exploration launched this week by a ANSM health regulator will examination medication practices by doctors, who it says might be over-prescribing higher-risk third and fourth-generation pills.
While all verbal contraceptives are compared with a risk of blood clots, a series of studies advise a many new third and fourth-generation pills lift a aloft risk than their predecessors.
The European Medicines Agency says a risk of an embolism, or blood clot, is twice as high for women regulating third and fourth-generation pills than for those regulating progressing versions, nonetheless it stays low. The risk of a cadence is a same.
On Wednesday, France’s health method pronounced it would stop reimbursing medication costs of third-generation pills from Mar 31, bringing brazen a cut-off date from Sep 30.
The moves comes weeks after Marion Larat, 25, sued Germany’s Bayer and a French central over a cadence she suffered following use of a third-generation preventive tablet Meliane.
An exploration found her use of a tablet could have been obliged for her stroke, that led to prejudiced paralysis. Larat’s lawyers disagree Bayer should have cold a tablet from a market.
A mouthpiece for Bayer France pronounced on Thursday: “We will consider any allegations once we have perceived minute information and we will conflict appropriately.”
In October, Bayer pronounced it had set aside 200 million euros in a third entertain for lawsuit in a United States in tie with a Yasmin/Yaz birth control pills, carrying already concluded to compensate $750 million to settle 3,490 authorised claims that Yasmin caused blood clots.
Clots are purported in a serve 3,800 tentative cases.
U.S. health regulators in Apr combined warnings to a labels on newer birth-control pills sole there, observant they might lift a risk of blood clots.
France’s health regulator pronounced new-generation pills, that held on since they reduced side effects from prior versions such as weight benefit and acne, should usually be prescribed by dilettante doctors.
Currently gynecologists, midwives and nurses are certified to allot them or replenish prescriptions.
France, that reimburses 100 percent of medication costs for unchanging birth-control pills, is underneath vigour to cut costs and revoke a 8.6- billion-euro necessity in a health system.
(Reporting By Chine Labbe, Thierry Leveque and Elena Berton; Writing by Nicholas Vinocur; Editing by Jon Boyle and Jason Webb)
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