The Food and Drug Administration (FDA) is currently probing three potential health issues, including hair loss and thoughts of suicide, associated with a group of weight loss medications gaining popularity. The medications under scrutiny include Ozempic, Wegovy, Mounjaro, and Zepbound.
The FDA’s quarterly report, highlights an ongoing investigation into reports of alopecia (hair loss), aspiration (complications during surgery where individuals inhale objects into the airway), and suicidal ideation linked to the use of these medications.
FDA spokesperson Chanapa Tantibanchachai emphasized the agency’s commitment to monitoring drug safety throughout their life cycle, employing post-approval surveillance and risk assessment programs to identify and evaluate adverse events.
While some investigations might prove inconclusive, previous FDA probes have led to updates in drug labels or calls for additional studies. Tantibanchachai clarified that any identified safety signals would prompt the FDA to determine appropriate actions following a thorough review of available data.
Previous FDA inquiries have addressed potential issues related to GLP-1 receptor agonists (GLP-1 RA), a class of medications effective for weight loss and diabetes treatment. Last year, concerns about intestinal obstructions led to updates in Ozempic’s label.
Manufacturers Novo Nordisk and Eli Lilly expressed collaboration with the FDA in monitoring medication safety. Novo Nordisk affirmed confidence in the safety and efficacy of their GLP-1 RA medicines when used as indicated under professional healthcare guidance.
The FDA’s scrutiny includes the potential risk of suicidal ideation linked to GLP-1 RA medications like Ozempic and Wegovy, a concern that has garnered international attention. The European Medicines Agency is actively seeking clarifications from manufacturers regarding this risk.
As of September, FDA records cite 201 reports of suicide or suicidal ideation associated with semaglutide, the key ingredient in Ozempic and Wegovy, and tirzepatide, found in Zepbound and Mounjaro. The European regulator maintains that no conclusive association between the medications and suicidal thoughts has been established.
Alopecia, or hair loss, is another reported side effect with at least 422 records in FDA’s database for patients taking semaglutide or tirzepatide.
The issue of aspiration, where individuals inhale food or objects into their airway, has been mentioned in 18 reports associated with semaglutide or tirzepatide. The American Society of Anesthesiologists has urged patients to cease taking GLP-1 RA medications before elective surgeries due to the potential risk of complications related to delayed stomach emptying.
Both Novo Nordisk and Eli Lilly underscored their commitment to patient safety, with Eli Lilly emphasizing a rigorous study process and collaboration with the FDA on potential safety signals. The FDA continues to evaluate the available data, emphasizing a commitment to public health and safety.
