CNN —
The U.S. Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking drugs such as Ozempic, Munjaro, and Wigovy.
These drugs, known as GLP-1 receptor agonists, are approved to treat diabetes and weight loss. These include semaglutide under the brands Ozempic, Rybelsus, and Wegovy. Liraglutide, Saxenda and Victoza brand names. and tirzepatide, branded as Mounjaro and Zepbound. They mimic the hormone GLP-1, which is naturally produced in the body, and its role includes slowing the passage of food through the stomach.
After the FDA Adverse Event Reporting System, or FAERS, receives a report of alopecia or hair loss, the FDA “evaluates the need for regulatory action.” Aspiration, or the accidental inhalation of food, liquids, etc. Suicidal thoughts in people using these drugs.
“The inclusion of a drug on this list does not mean that FDA has concluded that the drug poses the listed risks,” the FAERS website states. “This means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risks.”
People who are using these drugs and have questions or concerns about side effects should talk to their health care provider, the FDA says.
“The FDA monitors the safety of drugs throughout their lifecycle, including after approval. In addition, the FDA uses postmarketing surveillance and risk assessment to identify and evaluate adverse events that did not appear during the drug development process. “We maintain a system of evaluation programs,” the FDA told CNN on Wednesday. “If new safety indicators are identified, FDA will thoroughly review available data to determine what actions, if any, are appropriate.”
These actions may include requiring label changes or developing a risk assessment and mitigation strategy, a program that ensures that the benefits of a drug product outweigh the risks.
Some studies have associated GLP-1 agonists with serious gastrointestinal disorders such as gastroparesis, pancreatitis, and intestinal obstruction, but the risk of these events appears to be rare. Many of these side effects are listed in the drug’s prescribing information or label.
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In June, the American College of Anesthesiologists warned that people using GLP-1 agonists may experience gastrointestinal problems, including nausea, vomiting, and delayed gastric emptying, and that they are “at increased risk for reflux and lung disease.” “The use of GLP-1 agonists should be discontinued one week before surgery.” Aspiration of gastric contents during general anesthesia and deep sedation. ” Vomiting while under anesthesia can allow food and stomach acid to get into your lungs, which can cause pneumonia and other problems after surgery.
European regulators have also been investigating the risk of suicidal thoughts in people taking these drugs for months, and whether the drugs caused the events or whether they are linked to other underlying conditions. is not clear.
Novo Nordisk and Eli Lilly, which manufacture a number of GLP-1 agonists, said in a statement that patient safety is their top priority and that they are working closely with the FDA to monitor safety.
