Diane 35: suspended in 3 months, unless

The National Security Agency of the drug (MSNA) has decided to initiate a suspension of marketing authorizations on the market (AMM) of Diane 35 and its generic, announced January 30, its director general Prof. Dominique Maraninchi. This will take full effect in three months, he said, to allow women time to find satisfactory therapeutic alternatives. But the European Commission may decide otherwise ...

In the sights of the MSNA before "case" of pills called ^3rd generation , Diane 35 would simply costs the review process of all medications prior to 2005 initiated by MSNA, ensures its director General. Hmm ... can still imagine that "the atmosphere of tension, health crisis," mentioned by Dominique Maraninchi itself is not foreign, even if he is forbidden. "We expected a decision in January," he said to the press.

Diane 35, an anti-acne essentially as prescribed pill

Diane 35 is an anti-acne marketed in France since 1987, but according to a survey of MSNA, it was prescribed "preferentially" as an oral contraceptive by gynecologists and general practitioners. Composition, combining estrogen (ethinyl estradiol) an inhibitor of testosterone, hangs in effect ovulation. However, "this drug is not approved as contraceptive treatment. This is not a good pill," insisted Professor Maraninchi. Not only the Bayer laboratory has never submitted an application for marketing authorization in this sense, but "data [he provided the MSNA] does not correspond to what is expected of contraception," he said the director general of the agency Doctissimo.
Except ... "The precautions in the RCP [summaries of product characteristics, ed] and MA are the same as those of a pill," recognizes the MSNA that evokes a "likelihood of confusion" patients . "The texts were ambiguous, they must be clear now."

Diane 35: scales unfavorable benefit / risk

The National Security Agency of the drug has initiated a reassessment of the benefit / risk balance of Diane 35 as anti-acne treatment. She questioned why the laboratory, reviewing the literature, consulting with experts ... Regarding its effectiveness, "Cochrane review shows that Diane 35 is superior to placebo beyond any doubt." But "analysis of cohort studies have shown that Diane 35 is associated with an increased risk of venous thromboembolic disease (risk multiplied by 4) compared to women not taking Diane 35," reported Dr. Maraninchi.
Moreover, "the national pharmacovigilance database shows that in 25 years, the side effects are mainly thromboembolic effects ( phlebitis , pulmonary embolism ), which were associated with 4 deaths, "but" it also shows that these adverse events are frequently associated with other risk factors "that only take Diane 35, said Dominique Maraninchi.

Suspension of Diane 35 and its generic three months

With these data, "the MSNA considers that the benefit / risk balance is unfavorable in the treatment of acne." And its CEO announced that "the MSNA decided to initiate a suspension of marketing authorizations for Diane 35 and all its generic." This will take effect in three months, so that patients find their doctor alternative therapies to treat their acne and those taking the drug as a contraceptive make the choice of another method of contraception. "Patients should not discontinue treatment immediately, they should expect to see their doctor in consultation with him to consider another treatment," Dominique Maraninchi recommended.
Doctors, meanwhile, "should no longer prescribe [Diane 35], neither initiation nor renewal." And it is advised pharmacists to prescribe a minimum to avoid any interruption of treatment. "At the end of 3 months, all prescription and delivery will be banned" and prizes will be withdrawn from the market.

The European Commission may decide to maintain the commercialization of Diane 35

Except that this decision purely French, will have little weight to that will face the European Medicines Agency (EMA). However, "a Community arbitration procedure was initiated by the MSNA," said Carole Le Saulnier, Director of Legal and Regulatory Affairs of MSNA. It is up to European health authorities to take a decision at the European level. Because to date, each country sells Diane 35 has a national marketing authorization, which can be highly variable from one Member State to another. The European Commission has 60 days to analysis and should give its opinion within two months and a half. It may decide to suspension or withdrawal of marketing authorization, or a harmonization of the SPC. "If the Commission requested a product reletting, France should comply with this European decision. Nevertheless, we would have authority to determine the conditions for prescribing and dispensing most likely to protect patients," said Carole Le Saulnier. Dominique Maraninchi and adds: "We'd definitely commercialization [Diane 35] in ultra-precise indications, under strict conditions and only in the treatment of acne."
Is there a risk that patients do massive postponement of other anti-acne, like Accutane generic *? "We will follow if there is a carry-over effect on other hazardous treatments," assured the Director General of MSNA. Meanwhile, as for the pills 3 ^rd and 4 ^th generations, it encourages women not to panic, not to immediately discontinue treatment and consult their doctor promptly. A discourse that becomes familiar to the ears of patients ...
Amélie Pelletier, January 2013
Source
Press Conference of MSNA, Wednesday, Jan. 30, 2013.
* In 2008, Accutane, an anti-acne treatment based isotretinoin was withdrawn from the market by the laboratory, but its generic ( Curacné , Procuta , Contracné or Isotretinoin Teva ) are always available. Many complaints have been filed in France and the United States against this drug, believed to be responsible for cases of depression and suicide.