CNN
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The US Meals and Drug Administration is evaluating studies of unintended effects resembling hair loss and suicidal ideas in individuals taking drugs like Ozempic, Mounjaro and Wegovy.
These medication, often known as GLP-1 receptor agonists, are permitted to deal with diabetes or weight reduction. They embody semaglutide, branded as Ozempic, Rybelsus and Wegovy; liraglutide, branded as Saxenda and Victoza; and tirzepatide, branded as Mounjaro and Zepbound. They mimic GLP-1, a hormone made naturally within the physique whose roles embody slowing the passage of meals via the abdomen.
The FDA is “evaluating the necessity for regulatory motion” after its FDA Opposed Occasion Reporting System or FAERS obtained reports of alopecia, or hair loss; aspiration, or by chance inhaling issues like meals or liquid; and suicidal ideation in individuals utilizing these drugs.
“The looks of a drug on this listing doesn’t imply that FDA has concluded that the drug has the listed threat,” the FAERS web site notes. “It signifies that FDA has recognized a possible security subject, but it surely doesn’t imply that FDA has recognized a causal relationship between the drug and the listed threat.”
Individuals who use these drugs and have questions or issues about unintended effects ought to communicate with their well being care supplier, the FDA says.
“The FDA displays the security of medication all through their life cycle, together with post-approval. As well as, the FDA maintains a system of postmarketing surveillance and threat evaluation applications to determine and consider adversarial occasions that didn’t seem throughout the drug improvement course of,” the company advised CNN on Wednesday. “If newly recognized security indicators are recognized, the FDA will decide what, if any, actions are applicable after an intensive evaluation of accessible information.”
These actions might embody requiring labeling adjustments or improvement of a Risk Evaluation and Mitigation Strategy, a program that helps guarantee a medicine’s advantages outweigh its dangers.
Some analysis has linked GLP-1 agonists to serious digestive problems resembling abdomen paralysis, pancreatitis and bowel obstructions, though the dangers of those occasions look like uncommon. Many of those unintended effects are talked about within the medication’ prescribing data or on their labels.
The American Society of Anesthesiologists recommended in June that individuals who use GLP-1 agonists cease taking them for every week earlier than surgical procedures due to the potential for gastrointestinal issues like nausea, vomiting and delayed gastric emptying which will “enhance the chance of regurgitation and pulmonary aspiration of gastric contents throughout normal anesthesia and deep sedation.” Vomiting beneath anesthesia typically causes meals and abdomen acid to get into the lungs, which might trigger pneumonia and different issues after surgical procedure.
For months, European regulators have additionally been investigating the chance of suicidal ideas in individuals taking these drugs, though it’s not clear whether or not the medicines triggered the occasions or whether or not they might be linked to different underlying situations.
Novo Nordisk and Eli Lilly, which make plenty of the GLP-1 agonists, stated in statements that affected person security is their prime precedence and that they’re working intently with the FDA to watch security.