FDA Investigating Reports of Serious Complications With Semaglutide (Ozempic) and Related Weight-loss Drugs

Suicidal ideation, aspiration, and alopecia added to the list as new safety concerns

The FDA’s Adverse Event Reporting System (FAERS) has listed three complications — suicidal ideation, aspiration, and alopecia — in association with popular weight-loss drugs in the glucagon-like peptide-1 (GLP-1) receptor agonist class.

Drugs in this class include semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza). They are seeing wider use, including off-label use, in the face of the obesity epidemic.

We are covering this in CORRelations because an increasing number of patients (and their surgeons) may consider these medications as alternatives to bariatric surgery in order to lower BMI in advance of joint arthroplasty and other orthopaedic procedures.

These drugs appeared on the FAERS list that is considered current as of January 2nd, 2024, and reflects “potential signals of serious risks/new safety information” from July to September 2023.

The FDA notes that when a drug is listed on FAERS, “there is no certainty that the reported event . . . was due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.” The FDA further states:

If a potential safety concern is identified in FAERS, further evaluation is performed. Further evaluation might include conducting studies using other large databases, such as those available in the Sentinel System. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

The current American Society of Anesthesiologists guideline for patients taking GLP-1 receptor agonists states in relevant part:

For patients on daily dosing consider holding GLP-1 agonists on the day of the procedure/surgery. For patients on weekly dosing consider holding GLP-1 agonists a week prior to the procedure/surgery.

Orthopaedic surgeons should be aware of that guideline, which is available here.