Thursday, April 24th, 2014

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

Luis Miranda
The Real Agenda
January 31st, 2013
Reader Views: 1,102

d35

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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Contributed by Luis Miranda of The Real Agenda.

Luis R. Miranda is the Founder and Editor of The Real Agenda. His 16 years of experience in Journalism include television, radio, print and Internet news. Luis obtained his Journalism degree from Universidad Latina de Costa Rica, where he graduated in Mass Media Communication in 1998. He also holds a Bachelor’s Degree in Broadcasting from Montclair State University in New Jersey. Among his most distinguished interviews are: Costa Rican President Jose Maria Figueres and James Hansen from NASA Space Goddard Institute.

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  • http://NONE Arizona

    GEE,we know it kills young women but keep giving it to them,OH and we decided to ban it,IS THAT SOME SORT OF DOUBLE TALK OR WHAT??when you got a poison on the shelf thats killing,shouldn’t it be pulled the minute you discover it???WHATS UP with that??SOUNDS like you french need to introduce the MSNA doctors to a necktie party,I think they are in the pocket of the drug companies,DON’T YOU??how long has this been killing women in other countries and no on said anything about it???? maybe years?? the doctors are getting rich while the women are dropping dead….we have the same problem in america too,but not much longer……….

  • Bill X

    http://news.yahoo.com/health-canada-reviewing-safety-drug-diane-35-known-225645435.html

    The women died of blood clots linked to their use of Diane-35, an acne drug that is also widely prescribed as an oral contraceptive because it halts ovulation. It has been sold in France since 1987.

    Available since 1998 in Canada, Diane-35 is approved only for the temporary treatment of severe acne in women who are unresponsive to other treatments, Health Canada said Thursday.

    However, the drug is often prescribed “off-label” as a contraceptive.

    Blood clots are a rare but well-known side-effect of oral birth control pills and other hormonal products such as Diane-35, said the federal department, noting that the product monograph for the drug contains clear warnings about this potential adverse effect.

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