French Regulators Take On Birth Control Amid Side-Effect Concerns

Photo: Nickle

Photo: Nickle

French health authorities have proposed a restriction on so-called “newer-generation” contraceptive pills citing health risks –namely of blood clot and stroke—reported France’s Agence France-Presse on Friday, January 8.

Urging other European countries to follow suit, French Health Minister Marisol Touraine indicated she would request that the European Medicines Agency (EMA) to amend its approval of 3rd and 4th generation birth control pills.  “These pills [should] no longer [be] prescribed to women as a first option,” Touraine said in a statement.

The term “newer-generation” birth control generally refers to the “3rd generation” oral contraceptive, introduced in the 1990s, and its “4th generation” follow-up, which gained popularity in the last decade.  Both are distinguished from earlier versions by their inclusion of a synthetic of the naturally produced female hormone progestogen.  The synthetic answer to progestogen was examined in a Danish study from 2011, which found that subjects ran twice the risk of developing blood clots when taking newer-generation birth control pills than when on a routine of their earlier versions.  Compared to non-users of the Pill, users of 3rd and 4th generation oral contraceptives were found to run three to six time the risk of blood clot, reports AFP.

Around 2.5 million women in France are on the 3rd and 4th generation forms of birth control pills, accounting for about half of all oral contraceptive users.  Touraine has voiced her interest in urging health care providers to favor the 2nd generation pill when prescribing.  Under European rules, member states must accept medications approved by the EMA, but they may make recommendations against their use.  Member states may not unilaterally ban EMA-approved medications.

Agence France-Presse reports that opposition to newer-generation oral contraceptives has gained momentum following the lawsuit of a 25-year-old Frenchwoman who was badly handicapped by a stroke attributed to her birth control pill regime.  Her lawyer said in December that 30 other women are likely to file a suit targeting major pharmaceutical companies for the harmful side effects of newer-generation oral contraceptives.

Last year, the US Food and Drug Administration required newer-generation oral contraceptives Yasmin, Yaz, Beyaz, and Safyral, to carry labels warning of higher risk of clots after pharmaceutical giant Bayer spent over $750 million to settle lawsuits over negative side effects experienced by more than 8,000 users.

The French government will cease to reimburse newer-generation oral contraceptives come September 30.  The EMA has stated it sees no change recommendations regarding the use of the pills in question.

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