EU drug agency to review safety of new-generation Pill
PARIS (AFP) – 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.
The agency, describing oral contra-ceptives as carrying only “a very rare risk” of clots, said a watchdog panel would assess whether European guidelines for using later versions of the Pill should be changed.
On January 11, France announced it would ask the EMA to modify pre-scription recommendations for the third- and fourth-generation pills.
It pointed to evidence that their use led to higher risk of blood clots compared with older versions of the Pill, although the risk in absolute terms is small.
France wants guidelines changed so that doctors no longer prescribe later-generation pills as a first option.
EMA said its Pharmacovigilance Risk Assessment Committee (PRAC) would be carrying out the review, the first time a member-state has asked for such an assessment for a contraceptive pill.
“Combined oral contraceptives are kept under close monitoring by national pharmacovigilance systems,” EMA said in a press release. “There is no reason for any woman to stop taking her contra-ceptive. If a woman has concerns, she can discuss this with her doctor.”