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LONDON Jan 11 European drug regulators said on
Friday there was no reason for women to stop using combined
contraceptives like Bayer's Meliane or Yasmin pills
since there was no new evidence pointing to safety risks.
The move comes after French health regulators said last week
they were considering limiting use of some birth control pills
after a woman sued the German drugmaker over alleged
In a statement responding to reports about the so-called
"third-generation" contraceptive pills and blood clots known as
venous thromboembolisms, the European Medicines Agency (EMA)
said it was already well known that the pills "carry a very rare
risk of blood clots".
It said that risk differs between types of combined
"These products are constantly and rigorously kept under
close monitoring. There is currently no new evidence that would
suggest any change to the known safety profile of any combined
contraceptives marketed today," the agency said. "There is no
reason for any woman to stop using her contraception."
EMA says the risk of a blood clot is twice as high for women
using third and fourth-generation pills than for those using
earlier versions, although it remains low. The risk of a stroke
is the same.
France's health ministry said on Jan. 3 it would stop
reimbursing prescription costs of third-generation pills from
March 31 after a 25-year-old woman sued Bayer and a French
official over a stroke she suffered following use of the
third-generation contraceptive pill Meliane.
An inquiry found her use of the pill could have been
responsible for the stroke, which led to partial paralysis. Her
lawyers argue Bayer should have withdrawn its pill from the
The EMA said Europe's regulatory network had a robust system
in place to deal with safety issues with medicines.
"Under this system, any new safety-related evidence that a
member state has, should be made available to the European
Medicines Agency so that it can be assessed and appropriate
actions can be taken to protect patients right across the
European Union," it said.
(Reporting by Kate Kelland; Editing by Mark Potter)