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

The US Food and Drug Administration (FDA) is currently reviewing reports of side effects such as hair loss and suicidal ideations among individuals who have been taking certain medications such as Ozempic, Mounjaro, and Wegovy. These medicines, known as GLP 1 receptor agonists, are authorized for the treatment of diabetes or weight loss. These include semaglutide, sold under brand names Ozempic, Rybelsus, and Wegovy; liraglutide, sold as Saxenda and Victoza, and tirzepatide, sold as Mounjaro and Zepbound. They function by mirroring GLP 1, a hormone that naturally occurs in our bodies and helps slow food's transit through the stomach.

The FDA is "assessing the requirement for regulatory action" following reports to its FDA Adverse Event Reporting System or FAERS of hair loss, unintentional inhalation of substances like food or liquid, and suicidal thoughts from individuals using these drugs. The inclusion of a drug on this list does not indicate that the FDA has confirmed that it carries the listed risk, according to the FAERS website. Rather, it indicates the FDA has noted a potential safety issue, but it doesn't imply that the FDA has established a cause-and-effect relationship between the drug and the stated risk.

Those who have concerns or questions about side effects associated with these medications should consult their healthcare provider, advises the FDA. The safety of drugs is monitored by the FDA throughout their life cycle, which includes post-approval monitoring. If new safety signals are detected, the FDA will asses and determine appropriate actions following an exhaustive review of the available data.

Such actions might entail requiring changes in labeling or the creation of a Risk Evaluation and Mitigation Strategy, a program designed to ensure a drug's benefits outweigh its risks. Past studies have associated GLP 1 agonists with severe digestive issues such as stomach paralysis, pancreatitis and bowel obstructions, though these incidents seem to be rare.

The American Society of Anesthesiologists recommended in June that individuals using GLP 1 agonists should stop taking them a week prior to surgery due to potential digestive complications that may increase the risk of regurgitation during anesthesia. For some time now, European regulators have been examining the risk of suicidal ideations in users of these medications, but it is still unclear whether the medications directly caused these issues or if they may be connected to other underlying conditions.

Medication manufacturers Novo Nordisk and Eli Lilly, affirmed that patient safety remains their top priority and they are in close collaboration with the FDA to monitor safety matters. Eli Lilly further emphasized that their medications Mounjaro and Zepbound "are authorized for the treatment of critical diseases; they are not authorized for, nor should they be employed for cosmetic weight loss." Individuals undergoing mental health crises or exhibiting suicidal tendencies should reach out to a trained crisis counselor through the new three-digit code 988.