Spain will also investigate the health threats of Bayer’s Diane 35 drug

By LUIS MIRANDA | THE REAL AGENDA | JANUARY 31, 2013

Yesterday, the French National Agency for the Safety of Medicines (MSNA) announced it decided to suspend the sale of Diane 35, a drug that is prescribed to combat acne, but that is also provided as contraceptive pill. The agency made the decision to issue such suspension after four women died mysteriously after using the drug.

As explained by the MSNA, Diane 35 may be the trigger for what is known as thromboembolic disease, which first reports say, were the cause of the deaths in France.  MSNA director, Dominique Maraninchi, said Wednesday that it is unclear among experts what kinds of acne can be treated with this drug and that they have concluded that taking Diane 35 quadruples the risk of thromboembolic disease.

Meanwhile in Spain, the warning issues by the French agency prompted the Spanish Agency for Medicines and Health Products (Competent Authority) to begin a review of the drug due to its effects in generating excessive risk of blood clots (venous thromboembolism).

Two suspicious ingredients, when combined, seem to be the ones responsible for the deadly reaction. Drugs like Diane 35 and Dianette, contain cyproterone acetate and ethinyl estradiol, which are thought to cause thromboembolic disease. The Spanish review scheduled for next week, will be conducted by the European medical and pharmaceutical watchdog.

In France, the MSNA decided to stop funding these pills a few weeks ago, and finally opted for the full suspension because of the four deaths that apparently were caused by thromboembolic disease.

In Spain, the use of the drug was authorized since 1981, but in 2002 was restricted to treat “androgen-dependent diseases in women, such as acne, those which are accompanied by seborrhea or by inflammation or formation of nodes (acne Papulopustulosa, nodular acne), androgenic alopecia and mild forms of hirsutism” says AEMPS.

In total it is estimated that in Spain some 100,000 to 150,000 women are treated with Diane 35. Despite the alert issued by France’s MSNA, doctors are still allowed to prescribe the drug to patients until a final review is concluded.

The well-known risk created when combining  cyproterone acetate and ethinyl estradiol, is also related to obesity, immobility and history of varicose veins and thrombosis in the family.

Bayer, which manufactures Diane 35, issued a note showing surprise for the decision of the French health authorities. They say that “Bayer is not aware of any new evidence that may lead to change the positive risk-benefit assessment of Diane 35” which has been marketed for 25 years in over one hundred countries and had never been removed for security reasons.

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Bayer’s Diane 35 drug linked to death of four women

France suspends sale of Diane 35 until further research is done.

By LUIS MIRANDA | THE REAL AGENDA | JANUARY 30, 2013

The French National Agency for the Safety of Medicines (MSNA) announced today that it has decided to suspend the sale of Diane 35, a drug generally used to combat acne, but that is also sold as a contraceptive. The decision was made after four women who used the pharmaceutical product died mysteriously.

The action against the generic product will take effect within three months, and health authorities advised women who use the drug to consult with their physicians regarding any treatment options that involve the use of Diane 35.

MSNA director, Dominique Maraninchi, said today at a press conference that specialists should stop prescribing the drug, and pharmacists should continue providing it in the right doses to avoid sudden breaks in treatment.

The MSNA explained Monday that the death of four women on a date that was not specified by the entity, was caused by a venous thrombosis linked to the consumption of Diane 35, a drug that is approved in 135 countries and marketed in 116 of them.

Diane 35, whose marketing in France dates back to 1987, is indicated for acne, but its ability to inhibit ovulation has made it a recommendation for contraception.

“It’s not a pill and it should not be prescribed as such,” Maraninchi said today, emphasizing that the review that his agency has completed  about the product did not found sufficient data to ensure its effectiveness for this purpose.

The representative of the agency said that it is unclear among experts what kinds of acne can be treated with this drug and that they have concluded that taking Diane 35 quadruples the risk of thromboembolic disease.

Although the MSNA asserted that the risk of thromboembolic disease is related to other factors in addition to the use of the drug, the statement said that given the current scenario, the organization opted to withdraw approval for the sale of the product and to issue an alert to the rest of its European counterparts on the decision.

The decision to ban the sale of Diane 35 comes after the French government decided this month to encourage physicians to prescribe second-generation pills instead of third and fourth generation ones, in order to minimize the risk thrombosis.

In this particular case, the European Medicines Agency (EMA), responsible for the scientific evaluation of medicines sold in Europe, said there was no reason for any woman to stop taking combined birth control pills considering that no new evidence existed that those may pose health risks.

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