The Food and Drug Administration (FDA) is currently investigating the potential association of three health concerns or adverse effects—namely, hair loss, thoughts of suicide, and aspiration—with a group of medications that have gained considerable popularity for their application in weight loss.
Notable among these medications are Ozempic, Wegovy, Mounjaro, and Zepbound.
The disclosure of this investigation occurred on Tuesday through a quarterly report released by the FDA.
The report outlined the agency’s examination of reported cases involving alopecia, a condition characterized by hair loss; aspiration, a complication observed during surgery when individuals inhale food or other objects into their airway; and suicidal ideation among individuals using the mentioned medications.
FDA Flags Hair Loss Issues in Wegovy Pre-Approval Evaluation
During the FDA’s pre-approval review of Wegovy, concerns related to hair loss and thinning were highlighted, with a higher frequency of reports among participants administered semaglutide in Novo Nordisk’s clinical trial compared to those receiving a placebo.
In the FDA’s documentation, there are a minimum of 422 reports documenting instances where patients taking semaglutide or tirzepatide have reported alopecia, a medical term denoting hair loss.
Various medications, including certain antidepressants and birth control pills, have previously been associated with causing hair loss.
In the trials conducted by Eli Lilly for tirzepatide in the context of obesity treatment, physicians have observed an increased incidence of patients reporting alopecia.
Suicidal Ideation Risk Sparks Intensive Review of GLP-1 RA Medications
The potential risk of experiencing suicidal ideation associated with the use of GLP-1 RA medications, such as Ozempic and Wegovy, has been under extensive scrutiny from experts and health authorities for several months.
Internationally, the European Medicines Agency recently expressed the need for additional clarifications from manufacturers of GLP-1 RA medications regarding the potential risk of suicidal thoughts.
The European regulator’s drug oversight panel is scheduled to revisit this issue in its April meeting this year, following a thorough review initiated in July 2023.
To date, the European regulator has stated that “no conclusion can be drawn on a causal association” between these medications and thoughts of self-harm.
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