Weight-loss, diabetes drugs like Ozempic under review for side-effect reports

Thursday, January 4, 2024
FDA reviewing Ozempic, other drugs for reports of side effects
Ozempic and other drugs for diabetes and weight loss are under new scrutiny after reports of hair loss, suicidal thoughts and other side effects.

The US Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications like Ozempic, Mounjaro and Wegovy.

These drugs, known as GLP-1 receptor agonists, are approved to treat diabetes or weight loss. They include semaglutide, branded as Ozempic, Rybelsus and Wegovy; liraglutide, branded as Saxenda and Victoza; and tirzepatide, branded as Mounjaro and Zepbound. They mimic GLP-1, a hormone made naturally in the body whose roles include slowing the passage of food through the stomach.

The FDA is "evaluating the need for regulatory action" after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.

"The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk," the FAERS website notes. "It 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 risk."

People who use these medications and have questions or concerns about side effects should speak with their health care provider, the FDA says.

"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," the agency told CNN on Wednesday. "If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data."

These actions may include requiring labeling changes or development of a Risk Evaluation and Mitigation Strategy, a program that helps ensure a medication's benefits outweigh its risks.

Some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs' prescribing information or on their labels.

The American Society of Anesthesiologists recommended in June that people who use GLP-1 agonists stop taking them for a week before surgical procedures because of the potential for gastrointestinal problems like nausea, vomiting and delayed gastric emptying that may "increase the risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation."

Vomiting under anesthesia sometimes causes food and stomach acid to get into the lungs, which can cause pneumonia and other problems after surgery.

For months, European regulators have also been investigating the risk of suicidal thoughts in people taking these medications, although it's not clear whether the medicines caused the events or whether they may be linked to other underlying conditions.

Novo Nordisk and Eli Lilly, which make a number of the GLP-1 agonists, said in statements that patient safety is their top priority and that they are working closely with the FDA to monitor safety.

Eli Lilly issued a statement on Thursday reiterating the idea that Mounjaro and Zepbound "are indicated for the treatment of serious diseases; they are not approved for - and should not be used for - cosmetic weight loss."

If you are experiencing suicidal, substance use or other mental health crises, please call or text the new three-digit code at 988. You will reach a trained crisis counselor for free, 24 hours a day, seven days a week. You can also go to 988lifeline.org.

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