Pharmacovigilance Risk Assessment Committee (PRAC) to review third and fourth generation oral contraceptives

January 29, 2013 | By Márcio Barra

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review third and fourth generation combined oral contraceptives, under recent initiatives in France against these drugs. This comes as a request from France, and is  noteworthy as it is the first time, since the implementation of the new Pharmacovigilance Regulation adopted back in 2010, that a Member State has requested the European Agency to provide a recommendation or re-evaluation of a drug.

The PRAC will review the available data on the contraceptives and evaluate if the current information on them is of quality and accurate. Information on this review will be published following the next week meeting of the Committee, on 4 to 7 February 2013.

This review follows growing media reports about venous thromboembolism (VTE or blood clots) due to use of these contraceptives. A notorious case even went to court, after a woman, Marion Larat, sued Bayer after suffering a stroke cause by a blood clot, supposedly caused by taking Meliane (a combination of gestodene and ethinylestradiol), a third generation pill. Moreover, the French Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) launched, earlier this week, an investigation into the acne drug Diane-35 (cyproterone and ethinylestradiol), from Bayer. The investigation was triggered after four deaths in France were linked to the use of Diane-35, and reports from 125 women who suffered adverse reactions. Some reports also state that this acne drug stops ovulation, and is thus used as a contraceptive. It was approved for sale in France in 1987.

For the sake of clarity, the different generations of combined pills are due to different types of progestogens used. Each combined pill has a estrogen, usually ethinylestradiol, and a progestogen. First generation progestogens are norethindrone, norethindrone acetate and ethynodiol diacetate. Levonorgestrel and norgestrel are the second-generation progestogens. Levonorgestrel is the most widely used progestogen. Third-generation are desogestrel, gestodene and norgestimate, introduced in 1980. Drospirenone is the only fourth generation progestogen, available through the pill Yasmin, from Bayer.




The third generation pill controversy (“continued”) 



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