HEALTH : CONTRACEPTIVE CONCERNS: EMA TO SETTLE THE ISSUE IN SEPTEMBER.

Position:European Medicines Agency
 
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Under pressure from France, the European Medicines Agency (EMA) is expected to publish an opinion on the health-related risks of several combined oral contraceptives (COC) in September. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will give a recommendation on the Diane 35 pill mid-May, and another in July on other hormonal contraceptives authorised at EU level. Thereafter the EMA will adopt a position, which will becoming binding at EU level. This was announced by EMA Head of Patient Health Protection Unit Noel Wathion, at the EP's Environment, Public Health and Food Safety (ENVI) Committee on 26 March.

Indeed, several MEPs voiced concerns about the current system, raising questions such as: Why are third and fourth generation pills still being prescribed despite knowledge that first and second generation pills are less dangerous? Why are the leaflets that come with pills different from country to country? Why isn't there a centralised authorisation system at EU level?

DIFFERENT GENERATIONS OF PILLS

There are currently two types of contraceptive pill: the progesterone only pill, which contains a synthetic derivative of just one hormone - progesterone; and the combined pill, which contains derivatives of two synthetic hormones - progesterone and oestrogen. There have been several changes in the progesterone used in the combined oral contraceptive pills, and, more recently, in the oestrogen also. These changes are the reason why the newer pills are considered next generation pills. However the changes have led to new health risks. According to a report by the British Medical Journal, the risk of venous thromboembolism (VTE) is twice as high with third or fourth generation pills, as it is will second generation pills. On 11 January, the EMA confirmed in a press release that the risk is in fact higher: "It is well established that combined contraceptives carry a very rare risk of venous thromboembolism (VTE or blood clots) [...] and the risk differs between different generations of combined contraceptives." The EMA noted, however, that there was currently no evidence of any change in the safety of combined contraceptives currently on the market.

FRANCE CONCERNED

According to a study released by the French medicines regulatory agency (ANSM) on 26 March, the risk of VTE linked to COCs is estimated at 2,529 cases each year, 1,751 of which are linked to the use of third and fourth generation pills. ANSM estimates that 20 pulmonary...

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