Weight loss, diabetes drugs like Ozempic under review for side effect reports

The US Food and Drug Administration (FDA) is assessing reports of adverse effects from drugs, such as Ozempic, Mounjaro, and Wegovy, which include hair loss and suicidal ideation. The medications under investigation, classified as GLP 1 receptor agonists, are approved treatments for diabetes and weight loss. They function by imitating GLP 1, a hormone naturally produced by the body, essential for controlling food transit in the stomach. The drugs include semaglutide, liraglutide, and tirzepatide marketed as Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, and Mounjaro and Zepbound, respectively. The FDA's Adverse Event Reporting System (FAERS) has received complaints of hair loss, unintentional ingestion of substance like food or liquid (aspiration), and suicidal thoughts from patients using these medications. The FAERS website clarifies that the appearance of any drug on this list does not imply an established risk. The FDA merely identifies a potential safety concern without confirming a direct link between the drug and the alleged risk. Patients using these drugs advised to consult their healthcare providers regarding any related concerns. The FDA conducts post-approval safety monitoring of drugs and maintains a system that identifies and evaluates unanticipated adverse events. Should new safety risks emerge, the FDA undertakes a meticulous review of the available data to decide on the next actions to take, which could range from labeling changes to formulating a risk and benefit balancing approach. GLP 1 receptor agonists have been linked to serious digestive issues such as stomach paralysis, pancreatitis, and bowel obstructions in some studies, although occurrences are uncommon. Most of these side effects and risks are provided in the prescribing information or labels of these treatments. The American Society of Anesthesiologists recommended pausing the use of these drugs a week before surgeries due to their potential to cause stomach-related issues. European regulators have also been assessing the likelihood of these medications causing suicidal ideations, but it remains unclear whether the drugs incite the events or if it correlates with certain pre-existing conditions. Novo Nordisk and Eli Lilly, manufacturers of several GLP 1 receptor agonists, have emphasized their commitment to patient safety and their close-liaison with the FDA for safety monitoring. They also stressed that Mounjaro and Zepbound are only indicated for severe disease treatment and are not approved for cosmetic weight loss.