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EMA starts contraceptive safety probe

Follows French investigation into Bayer’s Diane 35

EMA logoThe European Medicines Agency (EMA) has said it will start a review of third- and fourth-generation oral contraceptives at the request of France, which is carrying out its own probe into the products' safety.

At the start of the year the French government said it would stop reimbursing prescription costs for third- and fourth-generation oral contraceptives and issued advice indicating they should only be prescribed for women who cannot use other forms of contraception.

France's move was prompted by reports of blood clots (venous thromboembolism) with the more recently-introduced oral contraceptive products, which incorporate newer progestins such as drospirenone, gestodene and desogestrel, rather than the older drug levonorgestrel.

Leading third- and fourth-generation brands include Bayer's Meliane (ethinyl stradiol and gestodene) and Yasmin (ethinylestradiol and drospirenone) products, and have proved popular because they reduce side effects such as weight gain.

The EMA, which previously announced there was no new evidence of risk amid media reports focusing on oral contraceptive safety, said it had been asked to carry out the review "to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives".

The agency said that while the overall risk of clots with oral contraceptives is very small at 20 to 40 cases per 100,000 women per year, there is a higher risk with the third- and fourth-generation oral contraceptives compared to their first- and second-generation counterparts.

Last April, Bayer revised the labelling for its oral contraceptive products containing the progestin drospirenone, which collectively bring in sales of around $1.4bn a year, to warn of an increased risk of blood clots.

France's Agence Nationale de Sécurité du Médicament (ANSM) started an investigation into the safety of Bayer's Meliane earlier this month, and has since extended the probe to include the company's older Diane 35 (ethinylestradiol and cyproterone) product, a combined oral contraceptive which is also used to treat acne.

According to French newspaper Le Figaro, the agency is looking into reports of 125 women who suffered adverse events potentially linked to Diane 35 or generic equivalents.

The EMA said the review would be conducted by its Pharmacovigilance Risk Assessment Committee (PRAC), which next meets on February 4 to 7.

In the meantime, "there is no reason for any woman to stop taking her contraceptive", said the agency. "If a woman has concerns, she can discuss this with her doctor".

29th January 2013

From: Sales, Regulatory



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