The AEO warns of the side effects of these drugs, stresses which they have received approval and points out that they are not intended for weight loss
Due to a multitude of publications from many and varied sources on the use of injectable anti -diabetic drugs to manage body weight, the AEO issued a statement to inform health professionals and the public.
As the AEO points out, anti -diabetic drugs have not been studied and are not intended for use for aesthetic purposesthat is, for weight loss by healthy people.
Anti -diabetic drugs that are approved weight management are intended for additional obese patients (BM≥30) or overweight patients (BMI27) if they host at least one additional disorder associated with increased weight (eg hypertension, hypertension, hypertension, dyslipidemia, obstructive, sleep apnea, cardiovascular disease, etc.) and who do not have It responds satisfactorily to the low calorie diet anyway and increased physical activity.
Anti -diabetic drugs that do not have an approved indication of weight management in disease have not been studied and are not intended for this purpose.
The AEO stresses that ‘All anti -diabetic drugs are prescription and therefore prohibited advertising/promotion to the public in every way. According to the legislation, only medical information from medical visitors to health professionals who prescribe the drug is provided after a diagnosis only, while all the promotions/promotional materials of the companies are subject to AEO control. The AEO monitors the relevant reports on the press and social media and imposes the projected sanctions. “
The AEO calls on the public and health professionals not to use related publications as sources as sources, which promote the use of medicines either as consumer products for aesthetic purposes or as a promising solution to numerous health problems, besides approved indications.
All valid information about proper use of each drugthey are part of its registration license and are public and fully accessible through the website of the European Medicines Agency (EMA-since they are central AK). It is noted that this information is always up -to -date with the most recent evaluated safety and efficiency data, and therefore is the most reliable source of information for both health professionals (product features, risk management plan, etc.) and for the Common (leaflet).
“At present, in the wider category of injectable anti -diabetic drugs, other than insulinhave received a marketing authorization from the European Medicines Agency EMA following drugs (active substances):
Lyxumia (Lixisenatide), Victoza (Liglutidis), Saxenda (Ligloutidis), Trulicity (Doulaglutide) ozempic (semaglutide), Wegovy (semaglutidis), Mounjaro (Tirzepatide) that differ in approved indications as:
Ozempic, Lyxumia, Trulicity & Victoza: Suitable for adult treatment with type 2 diabetes
Wegovy and Saxenda: They are indicated as additional adult treatment on low -calorie diet and increased physical activity for weight management in obese patients (BMI ≥30) or overweight (BMI≥ 27) if they host at least one additional disorder associated with increased weight ( eg hypertension, dyslipidemia, obstruction, sleep apnea, cardiovascular disease, etc.), as well as additional obese adolescent treatment over 12 years of age with BMI corresponding to ≥30 kg/m2 of adults and weight greater than 60 kg.
Mounjaro: He has received both of the above indications in adults. ”
“According to the evaluation of the data resulting from the clinical trials and the circulation of the above medicines, their use is accompanied by inter alia by adverse effects of gastrointestinaloften manifested/very often (nausea, vomiting, diarrhea/constipation, indigestion, gastritis, gastroesophageal reflux, etc.) or less rarely (pancreatitis/acute pancreatitis and/or gallstones). In addition, a possible correlation of use of drugs has not yet been ruled out Development of malignancy of thyroid and pancreasas evidenced by the risk management plans of the products. The safety profile calls for special attention to examining the possible administration of adolescent weight management drugs. Consequently, the prescription is important to limit it to approved indicationsupon assessment of the potential risk factors of each patient and taking into account the available alternatives to seek the best therapeutic effect, minimizing as much as possible the possibility of a negative impact in the near or distant future, “the statement said.
Finally, the AEO recalls that the proper use of drugs is a prerequisite for maximum safety and competence and calls on health professionals and the public to trust valid sources to inform them in order to reach the most appropriate, strictly personalized treatment options.
Source :Skai
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