Health, Lifestyle

Diane and Méliane: very, very dangerous

These latest contraceptives with women’s names are at the centre of controversy in France due claims that they produce serious side effects in women.

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Carmen Esquivel

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The concern started in December, when Marion Larat filed a complaint against la Bayer due to a brain haemorrhage she suffered in 2006 that left her disabled.

The young woman of 25  claims that the Méliane contraceptive pill, produced by that chemical pharmaceutical company with a subsidiary in France, is responsible for the brain damage.

After Larat, another 14 women made claims against different brands of tablets for producing health problems.

The controversy increased when the French National Agency for Medicines and Health Products Safety (ANSM) confirmed the death of four women in the last 25 years due to deep vein thrombosis related to the consumption of Diane 35, which  was also related to 120 other cases.

This pill is  indicated for acne treatment and alopecia, but it is also used as a contraceptive.

Nevertheless, the health authorities consider that the assumed benefits of the drug are inferior to the risks associated to thrombosis, and besides, its efficacy as a contraceptive has not been proven by appropriate clinical trials.

For this reason, the ANSM decided to suspend the sale of Diane 35 and its generic drugs, and gave a three month period for its withdrawal from the market.

In the meantime, the Health minister, Marisol Touraine, ordered doctors to limit the prescriptions for other third and fourth generation drugs, and announced the suspension of their financing as of March.

Tourraine also requested that the European Union kept the prescription of this type of combined oral contraceptive, which is very popular in the region, under control.

These pills appeared on the French market in the 90s and currently two million women consume them.

At the request of France, the European Medicines Agency (EMA) has decided to initiate a revision process of Diane and its generic drugs.

Without judging the French decision, the EMA has confirmed that after the study, the committee for the evaluation of risks in pharmacovigilance material, will give out a recommendation and will indicate whether the authorizations in the market should be modified, suspended or revoked, in the interests of all of the patients in the community.

A few days ago the Agency declared that the risks of blood clots are very low in all contraceptives; nevertheless, it admitted that the incidence rate is higher in the more modern drugs, with a frequency of between 20 and 40 cases per one hundred thousand.

Nonetheless, that organization, with headquarters in London, believes that these incidents are very rare and there is no reason to suspend their sale.

Despite the calls to avoid panic, the matter has provoked a lot of concern and controversy in France, due to other health scandals that affected, above everything, women.

“If a drug is dangerous, and the relationship between risks and benefits is unfavourable, it should be suspended or withdrawn”, stated Jean-Paul Hamon, president of the Federation of Doctors of France, a syndicate of general practitioners and specialist liberals.

On the other hand, the gynaecologist Joelle Tort-Grumbach made the call to stop the alarming speech about LAS GRAJEAS of the third or fourth generation.

Along the same lines, Nathalie Bajos, from the National Institute of Health and Medical Investigation, said that we have to remember that no medicine exists with zero risks; even a common analgesic can lead to complications.

For many specialists, the risk of possible brain damage to those who consume these modern contraceptives is linked to other factors, like smoking, obesity or diabetes.

The issue generates concern, especially after the Mediator case, a product from the Servier laboratories for diabetes treatment that was withdrawn from market in 2009. Various studies support that Mediator is responsible for the death of around 500 people, as well as an undetermined number of people with cardiovascular and pulmonary damage.

Another recent health scandal was that of  the breast implants Poly Implant Prothése (PIP), manufactured with a gel for industrial use instead of medical use.

In the last year, more than 14,300 French women were subject to surgical intervention to remove these implants which  suffer  frequent tears and cause irritation and inflammation in the tissue.

With this history, it’s not a surprise that women abandon the use of these modern day contraceptives, in hope of r a profound investigation about their side effects.

 

(Translated by Jade Hewitt – Email: jadesweetdreams@gmail.com)

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