The U.S. Food and Drug Administration (FDA) has launched an investigation into the potential risks associated with the use of diabetes and weight-loss drugs like Ozempic, Wegovy, Mounjaro, and Zepbound. The federal agency is examining reports of adverse side effects, such as hair loss, suicidal ideation, and aspiration, linked to these medications. Glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that includes Ozempic and its counterparts, have gained popularity for their effectiveness in treating diabetes and aiding in weight loss. However, concerns have emerged recently regarding their safety profile.

Understanding Ozempic and GLP-1 Receptor Agonists

Ozempic, also known as semaglutide, was initially approved by the FDA for the treatment of type 2 diabetes. However, due to its weight-loss benefits, it has become increasingly prescribed as a diet drug. Novo Nordisk, the manufacturer of Ozempic, has even introduced a higher-dose version called Wegovy, specifically approved for weight loss. Eli Lilly, on the other hand, has released Mounjaro and Zepbound, competing GLP-1 drugs designed to treat diabetes and weight loss, respectively. These medications work by mimicking the GLP-1 hormone, which regulates insulin secretion and appetite.

FDA Investigation into Suicidal Ideation and Hair Loss

One of the most concerning side effects the FDA is investigating in connection to Ozempic and similar medications is suicidal ideation. Reports of suicide and suicidal thoughts associated with GLP-1 drugs, including Ozempic, Wegovy, and Mounjaro, have raised serious concerns about their safety. According to a quarterly report on adverse drug events issued on January 2, 2024, the FDA received 201 reports of suicide or suicidal ideation linked to these medications between July 2023 and September 2023. The agency is evaluating whether there is a causal relationship between these drugs and the reported adverse events.

Hair loss, medically known as alopecia, is another potential side effect being investigated by the FDA. The agency received 422 reports of alopecia in patients taking semaglutide or tirzepatide, the active ingredients in Ozempic, Wegovy, Mounjaro, and Zepbound. While hair loss is a known side effect of certain medications, including some antidepressants and birth control pills, the frequency and severity of alopecia reported with GLP-1 drugs have raised concerns.

Aspiration and Stomach Paralysis Risks

The FDA is also examining reports of aspiration, which occurs when food or other objects are inhaled into the airway. Although only 18 reports of aspiration were identified in the FDA’s database, there are growing concerns about the potential risk of stomach paralysis caused by GLP-1 drugs. Stomach paralysis, also known as gastroparesis, is a condition characterized by impaired stomach muscle function, leading to delayed stomach emptying. It can cause persistent nausea, vomiting, and other complications.

A research study published in October 2023 found that Ozempic carries a significantly higher risk of stomach paralysis compared to non-injectable weight loss drugs. In the study, researchers compared the gastrointestinal side effects of Ozempic and other GLP-1 agonists, such as liraglutide (Victoza and Saxenda), with bupropion-naltrexone, an oral weight management medication. The study authors concluded that the use of GLP-1 agonists for weight loss was more likely to cause stomach paralysis, pancreatitis, and bowel obstruction than the use of bupropion-naltrexone.

Novo Nordisk and Eli Lilly Respond

Novo Nordisk, the manufacturer of Ozempic and Wegovy, has emphasized that it stands behind the safety and efficacy of its GLP-1 drugs when used as indicated and under the care of a licensed healthcare professional. The company acknowledges the reports of adverse events but states that inclusion on the FDA’s list does not definitively establish a causal relationship between the drug and the listed risks. Eli Lilly, the manufacturer of Mounjaro and Zepbound, also acknowledges the ongoing investigation into the potential risks associated with GLP-1 drugs and is collaborating with the FDA to address these concerns.

FDA’s Role in Drug Safety Monitoring

The FDA continually monitors the safety of pharmaceutical drugs throughout their life cycle, including post-approval. The agency maintains a system of postmarketing surveillance and risk assessment programs, such as the FDA Adverse Event Reporting System (FAERS), to identify and evaluate adverse events that may not have been apparent during the drug development process. If new safety signals are identified, the FDA takes appropriate actions based on a thorough review of available data. This may include updating drug labels or implementing risk mitigation strategies.

Legal Implications and Ozempic Lawsuits

The concerns surrounding the safety of GLP-1 drugs have prompted individuals to pursue legal action against the manufacturers. Lawsuits have been filed against Novo Nordisk and Eli Lilly, alleging that the widespread use of Ozempic and similar medications has led to severe and long-lasting side effects, including gastroparesis or stomach paralysis. Plaintiffs claim that the drug labels failed to adequately warn users about the risk of such adverse events. While the number of Ozempic lawsuits currently filed is relatively low, product liability attorneys are investigating thousands of potential claims that may be filed in the future.

Safety of Diabetes and Weight-Loss Drugs

The FDA’s investigation into the potential risks associated with Ozempic, Wegovy, Mounjaro, and Zepbound underscores the importance of monitoring the safety of medications, particularly those used for diabetes and weight loss. The reported side effects, including suicidal ideation, hair loss, aspiration, and stomach paralysis, raise concerns about the overall risk-benefit profile of GLP-1 drugs. It is crucial for healthcare providers and patients to stay informed about emerging drug safety information and consult medical professionals for guidance on the appropriate use of these medications.