EMA offices, London

EMA starts contraceptive safety review

pharmafile | January 30, 2013 | News story | Manufacturing and Production, Sales and Marketing EMA, PRAC, VTE, contraception 

Europe’s health regulator is to examine the safety of newer forms of contraceptive pills following concerns over potential health risks for such combined drugs.

The review by the European Medicines Agency is designed to see whether changes to product information for third and fourth-generation oral contraceptives are needed.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is carrying out the work but the agency insists there is no reason for any woman to stop taking her contraceptive.

The French government has already said it will stop reimbursing prescription costs on later-generation products in a bid to reduce their use, and said women should use other forms of contraception if possible.

It requested the EMA to investigate to see whether these pills should be out of bounds to women unless they cannot take other drugs – the first time a member state has asked the EMA to give a Europe-wide recommendation for these medicines under new pharmacovigilance law.

Worries over potential side effects such as venous thromboembolism (VTE) or blood clots) have always been there with contraceptives, but the EMA insists the absolute risk is very small.

However, it concedes there is a higher risk for third and fourth-generation contraceptives compared with earlier ones.

Manufacturers are used to defending their brands: Bayer stuck up for its top-selling contraceptive brand Yasmin after studies in the British Medical Journal questioned the drug’s safety nearly two years ago, for example.

It contains the progestogen drospirenone, which is relatively common in later-generation pills.

“Combined oral contraceptives are kept under close monitoring by national pharmacovigilance systems,” the EMA says.

More details of the review are expected after the PRAC’s next meeting which is due to take place next week.

Adam Hill

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