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HEALTH

France calls in EU to review contraceptive pills

The European Medicines Agency (EMA) on Monday said it would review safety data for third- and fourth-generation birth control pills, responding to French concern that these contraceptives may cause dangerous blood clots.

France calls in EU to review contraceptive pills
File photo: Richard Dunstan

The European Medicines Agency (EMA) on Monday said it would review safety data for third- and fourth-generation birth control pills, responding to French concern that these contraceptives may cause dangerous blood clots.

The agency, describing oral contraceptives as carrying only "a very rare risk" of clots, said a watchdog panel would assess whether European guidelines for using later versions of the Pill should be changed.

On January 11, France announced it would ask the EMA to modify prescription recommendations for the third- and fourth-generation pills.

It pointed to evidence that their use led to higher risk of blood clots compared with older versions of the Pill, although the risk in absolute terms is small.

France wants guidelines changed so that doctors no longer prescribe later-generation pills as a first option.

EMA said its Pharmacovigilance Risk Assessment Committee (PRAC) would be carrying out the review, the first time a member-state has asked for such an assessment for a contraceptive pill.

"Combined oral contraceptives are kept under close monitoring by national pharmacovigilance systems," EMA said in a press release.

"There is no reason for any woman to stop taking her contraceptive. If a woman has concerns, she can discuss this with her doctor."

The third-generation Pill was introduced in the 1990s, and the 4th generation in the last decade.

They contain synthetic versions of the female hormone progestogen, which the makers say avoid some of the side-effects of older formulations.

A Danish study published in the British Medical Journal (BMJ) in 2011 found women who took one of the newer types of Pill ran twice the risk of developing blood clots in the veins than those who used older-generation drugs.

Compared with non-users of the Pill, the risk of a clot was between three and six times higher.

Clots formed in the veins can break up and be transported to the heart or lungs and may be fatal.

In absolute terms, though, the risk is small, experts stress.

EMA said that birth-control pills in general "carry a very rare risk" of these clots. It said there were between 20 and 40 cases per 100,000 women in one year of use; third- and fourth-generation pills carried a relatively higher risk. Risks were described in leaflets to patients and doctors.

About 2.5 million women in France take the 3rd- and 4th-generation Pill, about half of all oral contraceptive users.

The storm in France was triggered partly by the case of a 25-year-old woman, Marion Larat, who was left badly handicapped by a stroke that, in a lawsuit, she attributed to a later-generation pill made by German firm Bayer.

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HEALTH

Danish parties agree to raise abortion limit to 18 weeks

Denmark's government has struck a deal with four other parties to raise the point in a pregnancy from which a foetus can be aborted from 12 weeks to 18 weeks, in the first big change to Danish abortion law in 50 years.

Danish parties agree to raise abortion limit to 18 weeks

The government struck the deal with the Socialist Left Party, the Red Green Alliance, the Social Liberal Party and the Alternative party, last week with the formal announcement made on Monday  

“In terms of health, there is no evidence for the current week limit, nor is there anything to suggest that there will be significantly more or later abortions by moving the week limit,” Sophie Løhde, Denmark’s Minister of the Interior and Health, said in a press release announcing the deal.

The move follows the recommendations of Denmark’s Ethics Council, which in September 2023 proposed raising the term limit, pointing out that Denmark had one of the most restrictive abortion laws in Western Europe. 

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Under the deal, the seven parties, together with the Liberal Alliance and the Conservatives, have also entered into an agreement to replace the five regional abortion bodies with a new national abortion board, which will be based in Aarhus. 

From July 1st, 2025, this new board will be able to grant permission for abortions after the 18th week of pregnancy if there are special considerations to take into account. 

The parties have also agreed to grant 15-17-year-olds the right to have an abortion without parental consent or permission from the abortion board.

Marie Bjerre, Denmark’s minister for Digitalization and Equality, said in the press release that this followed logically from the age of sexual consent, which is 15 years old in Denmark. 

“Choosing whether to have an abortion is a difficult situation, and I hope that young women would get the support of their parents. But if there is disagreement, it must ultimately be the young woman’s own decision whether she wants to be a mother,” she said. 

The bill will be tabled in parliament over the coming year with the changes then coming into force on June 1st, 2025.

The right to free abortion was introduced in Denmark in 1973. 

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