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HEALTH : DIANE 35: PARIS CALLS BACK ALL STOCK IN SPITE OF PRAC OPINION.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that it is not necessary to remove the Diane 35 contraceptive pill and its generics from the market. In a 17 May opinion, the PRAC wrote that the benefits of the pill outweigh the risks, provided that it is prescribed in certain conditions. In spite of the committee's conclusions (which still need to be confirmed by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human, CMDh), on 21 May, the French medicines regulatory agency (Agence francaise de securite du medicament et des produits de sante, ANSM) started taking all available stock off the market, as it had committed to do in February.

There are currently two types of pills: the progesterone pill, which only contains a synthetic progesterone derivative; and the combined pill, which contains a combination of progesterone and a synthetic derivative of another hormone, oestrogen. The progesterone in the combined oral pills has changed several times, and more recently the oestrogen also. These changes, which are the reason it is a different generation pill, brought new risks. According to a study by the British Medical Journal, the risk of thromboembolism (formation of blood clots in the veins and arteries) is twice as high with third and fourth-generation pills as compared with second generation pills. In France, around a thousand people have already filed a complaint against the pharmaceutical industry, concerning health problems linked to their combined oral hormonal contraceptives.

BETTER RULES FOR USE

Diane 35 is authorised in all EU member states (except Cyprus) by national procedures. In France, it received a market authorisation for the treatment of acne in women in 1987, but in 80% of cases it continues to be prescribed as a contraceptive. The Europe-wide emergency review was initiated at the request of the French medicines regulatory agency (ANSM). PRAC subsequently concluded that "the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism."

PRAC recommended that "these medicines should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism (excessive unwanted growth of hair) in women of reproductive age" and only "when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed". PRAC noted that Diane 35 should not be used in combination with other hormonal contraceptives. It also suggested new contraindications and warnings to patients and health care professionals. Lastly, PRAC recommended establishing a risk management plan and that efforts be made to raise awareness of the risks, signs and symptoms of thromboembolism for prescribers and patients.

The final decision lies with the European Commission. After this last step, all the measures to make the use of these medicines safer will be implemented and will apply to all EU member states, including France.

Broader review

As well as this targeted review, the European Medicines Agency (EMA) is currently carrying out an overall review of combined contraceptives containing the following progestatives: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromine and norgestimate. PRAC's recommandations are expected for July. They will then be passed on to the Committee for Medicinal Products for Human Use (CHMP). As with Diane 35, the final decision lies with the Commission and will be legally binding in all EU member states.
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Publication:European Report
Geographic Code:4EUFR
Date:May 22, 2013
Words:560
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