Wednesday January 30, the National Security Agency of Medicines and Health Products (ANSM) announced the suspension of the acne-treatment pill Diane-35 beginning in three months.
As a result of France’s decision to suspend the medication, on Thursday January 31, the European Medical Agency (EMA), based in London, announced that they would be conducting a reexamination of Bayer Laboratory’s Diane-35 acne treatment as well as all of its generic forms. Once the reexamination is complete, the EMA will “make a recommendation of its usage and indicate whether Market Authorities need to be modified, suspended or revoked in the interest of all European medical patients.”
Bayer Laboratory declared that they find the French suspension “very surprising.” The Lab group denies that there has been any change in the “positive risk-benefit balance of Diane-35,” reminding that the medication is “authorized in 116 different countries and has been for the past twenty five years.”
However according to the investigation done by the ANSM, Diane-35, as a treatment for acne, has a negative risk-benefit balance due to the risk of venous and arterial thrombosis (blood clots in the veins and arteries).
The controversy lies in the fact that Diane-35 has been prescribed to over 315,000 women in France last year, a great number of whom use it as a contraceptive pill, while the commission for Market Acceptance Authority (AMM – Autorite de Mise sur le Marche) has not authorized it for contraceptive use.
This combined estrogen-progestin oral treatment for acne was first put on the market in 1982 under the name Diane and after 5 years changed its name to Diane-35. That same year, the French medical magazine Prescire already warned of “the risk of seeing this oral acne treatment being prescribed as an oral contraceptive.”
In a study conducted by a Danish laboratory in 2009, it was found that using Diane-35 increases the risk of suffering from blood clots in the veins by 6.68 times in the first year of treatment.
On May 12, 2011, the president of the AMM declared that it is “imperative that we know exactly who is prescribing and what and for what purpose,” launching the investigation. On July 11, 2011, the commission for AMM re-evaluted the benefits and risks of Diane-35, at which point the Bayer Laboratory had still not given their accounting information. The Vice-President of the commission, Jean-Francois Bergmann, observes “without the ‘contraceptive’ indication of the medication, Diane-35 is not reimbursed by social security and is therefore 7 to 10 times more expensive than other contraceptive pills. Prescribing this pill as a contraceptive enhances the lab’s marketing ability.”
The investigation was postponed until the AMM Commission brought it up again on November 8, 2012, triggered by the request from another laboratory to create a contraceptive generic version of the Diane 35 pill with 7 placebos completing a 28-day cycle.
On January 10, 2013, the ANSM declared that the Bayer Santé Laboratory “did indeed provide all the formal information requested, which the Agency will now evaluate.” On Sunday January 27, the ANSM proclaimed four deaths “due to venous thrombosis linked to the usage of Diane 35.” The director of the ANSM, Dominique Maraninchi, announced the next day to “immediately stop using Diane 35 as a contraceptive pill.”
In an investigation led by Le Figaro, a confidential document from the ANSM was uncovered on January 25, reporting 7 deaths registered as of 1987 relating to the intake of Diane-35 in France. 1 of the 7 deaths was reported in relation to one of the pill’s generic forms, and 4 were reported having been directly caused by the treatment with Diane-35. The main cause of deaths is given to be blood clots that formed in the veins.
The latter document also revealed 125 cases in France of embolic and thrombotic strokes due to the treatment. An embolic stroke is a stroke caused by a blockage in the arteries caused by an ‘embolus’ which is material coming from another part of your body, whereas a thrombotic stroke occurs when a blood clot blocks the flow of blood to the brain. The average age of the women who affected by such symptoms is 25 years. Of the 113 women who suffered from thrombotic effects, 68 of these recovered without any lesions, 7 were cured but were left with scars, and 30 have yet to recover.
In France alone, 4 to 5 million tablets of Diane-35 are sold every year. Over 50% of the time, the prescribed pill is given out as a contraceptive as opposed to its formal use as an acne treatment. Most countries are meant to label the medication as an “acne treatment,” but in some countries such as Ireland, Diane-35 is clearly labeled as a contraceptive. It has been proven by doctors around the world that the long-term intake of this medication puts women at a very high risk of blood clots and therefore strokes. Dr. Wooltorton, editor of the Canadian Medical Association Journal states, “Diane-35 should be reserved for temporary use in women with serious acne and should not be used solely as an oral contraceptive.”
Though this pill in particular has caused a big scandal, there have been a number of severe accidents and deaths due to the use of oral contraception, information that is being revealed more frequently. Just last month, Le Figaro reported 47 serious lesions – including embolic and thrombotic strokes – in women taking oral contraception included in a sample of 800,000 individuals only between 1998 and 2012. Extrapolating to the whole of France, populated by almost 33 million women, 83 deaths of women between the ages of 15 and 25 would be directly related to the use of oral contraception in the same period of time.