2023-07-07 18:13:51
Roaccutane: a well-known name for people suffering from severe acne. If this drug is no longer marketed today, it has been replaced by many generics. Contracne, Curacne, Procuta, Isotretinoin Acnetrait, prescribed for a period of six to eight months when other treatments have not sufficed, these products present significant risks, known for several years already. The National Agency for the Safety of Medicines and Health Products (ANSM) published a note on Thursday aimed at “raising awareness of the risks associated with oral isotretinoin”.
“These treatments are extremely effective, but work at the cost of significant adverse effects that need to be known and controlled,” underlines Nathalie Dumarcet, head of the dermatology drugs unit at the ANSM. Note that 122,580 people took isotretinoin in 2019. A relatively stable figure for ten years.
Cases of depression, even suicidal thoughts
First of all, there is a psychiatric risk, in particular of mood disorders. A national pharmacovigilance survey was carried out in 2021 on isotretinoin-based specialties to understand their links with mental disorders. In particular, the professionals analyzed the 449 cases of psychiatric disorders reported to regional Pharmacovigilance centers over thirty years. Among them, 43% have a depressive disorder, 10.7% have attempted suicide and 6% have taken their own lives. While only 9.8% had a psychiatric history.
However, the link between taking anti-acne and psychiatric disorders has not been scientifically established. “To date, there is no correlation, because these disorders are already observed in this young population [principale consommatrice d’isotrétinoïne]. There are too many confounding factors”, justifies the head of the dermatology drugs unit. Living with severe acne can also worsen mental health.
30% risk of fetal malformation
Contrary to what one might think, acne does not only affect teenagers. Women of childbearing age may be on treatment. And are subject to risks, especially for the fetus. About three out of ten babies whose mothers are treated with isotretinoin during pregnancy will have a serious birth defect, “even after just one dose,” adds the expert. If the risk of having a baby with a congenital anomaly is 2 to 3% for a woman not taking treatment, this risk reaches 30% when taking isotretinoin orally. “It’s huge,” insists Nathalie Dumarcet.
Among the malformations identified in the fetus: the anomaly of the central nervous system, the malformation of the brain, the face (eye too small, cleft lip) or heart problems. And that’s not all. Taking isotretinoin during pregnancy or in the months preceding it also increases the risk of miscarriage, stillbirth or death shortly after birth.
Solutions to reduce these risks
Faced with these risks, what to do? “It is mandatory to have contraception before taking this treatment,” recalls Nathalie Dumarcet, who goes even further: “We invite you to use a pill plus a condom or an IUD alone. » Put on the belt and suspenders, therefore, to be sure to reduce the risk of pregnancy as much as possible. The doctor also encourages taking a pregnancy test before the first intake, then every month in order to immediately stop the current treatment if the person realizes that she is pregnant. “We will then have to ask ourselves the question of what we do afterwards, but that is a personal choice. »
Regarding psychiatric disorders, Nathalie Dumarcet advises the person taking the anti-acne and their relatives to monitor any change in mood. “If ever a psychological disorder appears, the question will then arise whether or not to continue the treatment, but we are less categorical than in the case of pregnancy. The decision will be made in consultation between the patient and his doctor. » A risk-benefit balance. “It’s not worth taking these risks because we have two small pimples, summarizes the doctor. This treatment should only be taken if the acne is so severe that it’s ruining your life. »
Despite numerous warning measures, approximately 175 people become pregnant on isotretinoin each year. From September, all the boxes of this drug will have a QR code redirecting to videos reminding the risks of the treatment.
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