Possible Ozempic side effects including hair loss and suicidal thoughts probed by FDA
The Food and Drug Administration is looking into whether three possible health issues or side effects, including hair loss and thoughts of suicide, might be linked to a group of medications that have boomed in popularity for their use in weight loss, including Ozempic, Wegovy, Mounjaro and Zepbound.
The probe into these issues was disclosed Tuesday in a quarterly report by the FDA, which revealed that the agency is investigating reports of alopecia, a hair loss condition; aspiration, a complication during surgery when people inhale food or other objects into their airway; and suicidal ideation in people who used the medications.
"The FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process," FDA spokesperson Chanapa Tantibanchachai said in an email.
While issues investigated by the agency sometimes turn out to be little more than false alarms, the agency's previous probes of reported side effects have also often led to the FDA updating a drug's labels or precautions, or calling for additional study of the issue.
"If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data," Tantibanchachai added.
The agency has previously followed up on other reports of issues that might be caused by the medications, called GLP-1 receptor agonists or GLP-1 RA, which are also effective for treating diabetes.
Last year, the FDA said it had identified a possible signal of intestinal obstructions linked to the medication in reports to its FDA Adverse Event Reporting System, or FAERS. Ozempic's label was updated to acknowledge reports of the condition, which doctors call ileus.
"We are aware that, as part of those monitoring efforts, FDA is evaluating several potential signals related to GLP-1 RA medicines and has posted information about those ongoing assessments on its website," a spokesperson for Novo Nordisk, which manufactures Ozempic and Wegovy, said in an emailed statement.
Novo Nordisk "works closely" with the FDA to monitor the safety of their medications, the spokesperson said, and echoed the agency's warning that just because a health issue is reported to FAERS did not mean a causal link had been proven.
"Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional," the spokesperson said.
A spokesperson for Eli Lilly, which produces Zepbound and Mounjaro, said the newly identified safety signal followed "rigorous study for many years in clinical trials and a robust approval process" of the medications.
"Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals," the spokesperson said in a statement.
Suicidal thoughts
The potential risk of suicidal ideation from taking GLP-1 RA medications like Ozempic and Wegovy has already drawn months of scrutiny from experts and health authorities.
Overseas, the European Medicines Agency said last month it had asked for further clarifications from manufacturers of GLP-1 RA medications about the risk of suicidal thoughts. The European regulator's drug oversight panel is expected to discuss the issue again at its April meeting this year, following a monthslong review that began in July 2023.
So far, the European regulator says "no conclusion can be drawn on a causal association" between the medications and thoughts of self-harm.
The FDA's records tally 201 reports through September of reports of suicide or suicidal ideation from patients taking medications with semaglutide, the key active ingredient of Ozempic and Wegovy, or tirzepatide, the ingredient for Zepbound and Mounjaro.
Records in the FAERS database only tally reports from patients, health care providers and drugmakers through September. Reports for the last three months of 2023 are not expected to be published until the end of January.
Alopecia (hair loss)
In FDA's records there are at least 422 reports about patients taking semaglutide or tirzepatide that mention the term alopecia, which doctors use to describe hair loss.
A number of other medications have been linked to causing hair loss, including some antidepressants and birth control pills.
FDA's review ahead of Wegovy's approval flagged hair loss and thinning among the issues that were reported more with participants who were given semaglutide in Novo Nordisk's clinical trial, compared to those who got a placebo.
Doctors have also noted the higher number of patients who reported alopecia in Eli Lilly's trials of tirzepatide for obesity.
Aspiration
Only 18 reports of patients taking semaglutide or tirzepatide in FDA's database mention aspiration, which refers to when people inhale food or other objects into their airway.
They include a case report published in March from doctors in Canada of a patient who had too much food left in their stomach despite fasting for 18 hours before an operation. The patient had begun injections of semaglutide for weight loss two months before.
Doctors tell patients to stop eating before surgeries that require general anesthesia because of the risk it could be vomited up and end up in the lungs.
The American Society of Anesthesiologists called in June for patients to stop taking the GLP-1 RA medications before elective operations, over the potential risk it could lead to complications.
In a news release, the group cited "anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation."
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