The US Food and Drug Administration is investigating allegations of adverse drug reactions, including hair loss and suicidal thoughts, in patients using Wegovy, Mounjaro, and Ozempic.
GLP-1 receptor agonists are licensed medications for the treatment of diabetes and weight loss. These include tirzepatide, marketed as Mounjaro and Zepbound; liragutide, marketed as Saxenda and Victoza; and semaglutide, marketed as Ozempic, Rybelsus, and Wegovy. They act similarly to GLP-1, a hormone that the body naturally produces and which has the function of delaying food movement through the stomach.
The FDA is “evaluating the need for regulatory action” in response to complaints of alopecia, or hair loss; aspiration, or unintentionally breathing in food or liquid; and suicidal thoughts in patients using these drugs that were reported to the FDA Adverse Event Reporting System, or FAERS.
The FAERS website states, “The FDA has not concluded that the drug has the listed risk just because it is listed on this list.” “It indicates that the FDA may have found a safety concern, but it does not imply that the FDA has found a link between the medication and the mentioned risk.”
The FDA advises patients to see their healthcare professional with any questions or concerns they may have regarding adverse effects when using these medications.
“The FDA keeps an eye on pharmaceutical safety at every stage of development, even after approval. To discover and assess adverse events that did not surface during the drug development process, the FDA also maintains a system of postmarketing surveillance and risk assessment programs, the agency informed CNN on Wednesday. “The FDA will decide what, if any, steps are necessary following a comprehensive examination of existing data if newly found safety signals are identified.”
These steps could entail demanding label modifications or creating a program called a Risk Evaluation and Mitigation Strategy, which aims to guarantee that a medication’s advantages balance its drawbacks.
Although the risks of these events seem to be low, some research has connected GLP-1 agonists to major digestive issues such pancreatitis, intestinal blockages, and stomach paralysis. Several of these adverse effects are listed on the labels or in the prescribing information for the medications.
In June, the American Society of Anesthesiologists advised patients using GLP-1 agonists to cease taking them one week prior to surgery due to the possibility of gastrointestinal issues such as delayed gastric emptying, nausea, and vomiting, which could “increase the risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation.”Food particles and stomach acid can occasionally enter the lungs after vomiting while under anesthesia, leading to pneumonia and other post-operative complications.
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