Bayer’s Diane 35 drug linked to death of four women
January 30, 2013
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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