“”This measure aims to facilitate more equitable access to these treatments, available only on prescription“, justifies the ANSM in a press release. Until now, the initial prescription of these drugs had to be carried out by a doctor specializing in endocrinology-diabetology-nutrition but the renewals could be carried out by any doctor. From June 23, these drugs may be prescribed by any doctor according to the procedures for marketing authorization.
The health authority had warned at the end of May that it planned to expand the conditions of prescription and issuance of these drugs in the class of the GLP-1 analogs, which promote weight loss by imitating a digestive hormone. After several months of presence on the French AGLP-1 market (analogues of glucagon-like peptide-1) indicated in the treatment of obesity (Wegovy (semaglutide), Mounjaro (shooting) and Saxenda (liraglutide)), it says in its press release that “The limitation of the initial prescription to doctors specializing in endocrinology-diabetology-nutrition or competent in nutrition was able to slow down access to certain patients, due to sometimes important deadlines to consult a specialist“.
These drugs are second-line treatments, that is to say that they should only be prescribed “in the event of failure of nutritional management, and in association with a hypocaloric diet and physical activity“, Recalls the ANSM. They must”Not to be used for weight loss for aesthetic purposes, that is to say for weight loss in people without overweight or obesity and who have no health problems related to overweight“Because these inappropriate uses can expose to”Sometimes serious side effects“. Even if in terms of safety of use of AGLP-1 indicated in obesity, to date, there is no new security signal but several signals already known are in investigation at the national level within the framework of the reinforced monitoring of these products and at European level (previous non-arteritic ischemic optical neuropathy- Noian- and pregnancies occurred under oral contraception). favorable to these drugs is not called into question in the indications of the AMM.
The agency thus maintains “High vigilance on the use of these drugs and reinforced and continuous monitoring of risks associated with AGLP-1“. Regional Pharmacovigilance Centers (CRPV) in Montpellier and Limoges have been carrying out a national survey extended to the entire AGLP-1 class since 2019. This survey has focused on the severe undesirable effects of these drugs.