Side Effects of Ozempic, Wegovy, Similar Drugs Under Investigation for Suicide and Hair Loss Risks: FDA

The FDA has received more than 200 reports of suicide or suicidal ideations linked to widely used diabetes and weight loss drugs like Ozempic, Wegovy, Mounjaro and Zepbound.

Federal regulators indicate they have launched an investigation into potential increased risks of suicide, hair loss and other adverse side effects from Ozempic, Wegovy, Mounjaro and similar medications introduced in recent years for treatment diabetes and obesity, which have become hugely popular over the last year.

The U.S. Food and Drug Administration (FDA) issued a quarterly report (PDF) on adverse drug events on January 2, covering the period of July through September of 2023. The report, gleaned from the FDA’s Adverse Event Reporting System (FAERS), links a class of medications known as Glucagon-like peptide-1 (GLP-1) receptor agonists to incidents of suicide and suicidal ideation, alopecia and aspiration.

Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been increasingly prescribed as a diet drug in recent years, making it a blockbuster treatment that is now used by millions of Americans.

As a result of the popularity of Ozempic for weight loss, Novo Nordisk has introduced a higher dose version under the brand name Wegovy, which is specifically approved as a diet drug. However, it contains the same active ingredient.

Eli Lilly has also released competing GLP-1 drugs in the form of Mounjaro (tirzepatide), approved for diabetes treatment in 2022, and Zepbound, the weight loss version of the drug approved by the FDA last year.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Mounjaro lawsuits, Ozempic lawsuits and Wegovy lawsuits against the manufacturers, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to adequately warn about the risk of severe and long-lasting gastroparesis, or stomach paralysis, side effects.

In this latest FDA report, the agency indicates it had received 201 reports of suicide or suicidal ideations linked to a wide range of GLP-1 drugs by the end of September 2023, including Ozempic, Wegovy, and Mounjaro, as well as Byetta Bydureon, Saxenda, Trulicity, Victoza and Zepbound. The report indicates the agency is now “evaluating the need for regulatory action.”

A similar investigation is underway by the European Union’s European Medicines Agency (EMA), which began investigating Ozempic suicide risks in July 2023, following similar reports.

The EMA’s investigation into the medications came after reports from Iceland of patients having suicidal thoughts. The reports involved both Ozempic and Saxenda (liraglutide).

Novo Nordisk claims there are no known causal connections between Ozempic and suicide, and the two drugs do not carry label warnings in the United States or EU alerting patients to potential suicidal thoughts risks. However, the drug Wegovy, which is also a weight loss medication sold in the U.S. using semaglutide, does carry such a warning, calling for patients taking the drug to be monitored for suicidal thoughts and behaviors.

Suicide risks and ideations have long been linked to weight loss drugs, such as Contrave and Qsymia, making it difficult for them to gain approved in the U.S. However, Wegovy and similar drugs are being approved at a rapid rate, since they are much more effective than earlier obesity treatments.

Ozempic, Mounjaro Aspiration and Hair Loss Reports

In addition, the FDA report also noted the agency is investigating GLP-1 medications for links to alopecia, or hair loss, and aspiration, which occurs when food is inhaled into the airway.

According to the report, the FDA received 422 reports of alopecia during the three-month time period, and 18 reports of aspiration.

While clinical trials linked Wegovy to triple the risk of hair loss when compared to those who took a placebo, no such side effects are listed in reference to Ozempic, which is typically given at a much lower dose when used for treatment of diabetes.

Manufacturers and some health experts say the hair loss, known as alopecia, may be related to the rapid weight loss the drugs are causing. Patients undergoing weight loss surgery are often warned of the risk of hair loss due to the body’s attempt to conserve resources, but some consumers say there appears to be something more serious happening.

The reports of aspiration, however, may be linked to concerns about stomach paralysis, caused by the drugs’ mechanism of action, which delays emptying of the stomach.

Ozempic Stomach Paralysis Side Effects

Stomach paralsysis, or Gastroparesis, is a painful condition that impacts the stomach muscles and prevents proper stomach emptying. It is also sometimes referred to as gastric stasis or a gastric obstruction, and typically resulting in persistent nausea, vomiting and other complications, which often require repeated hospitalizations or medical visits.

A study published in October found that Ozempic triples the risk of the stomach paralysis among users when compared to users of non-injectable weight loss drugs. The research compared the gastrointestinal side effects of Ozempic and other injectable GLP-1 agonists like liraglutide (Victoza and Saxenda) against those experienced by users of Contrave (bupropion-naltrexone), an oral weight management medication.

The findings indicated that about 1% of Ozempic users developed stomach paralysis, compared to 0.7% of liraglutide users and around 0.3% of those on Contrave. The study highlighted that injectable semaglutide and liraglutide were significantly more likely to cause stomach paralysis and bowel obstruction than Contrave.

January 2024 Ozempic Side Effects Lawsuits Update

The FDA report comes as a growing number of  complaints are being filed in U.S. District Courts nationwide, each describing similar circumstances were users experienced permanent injuries from gastroparesis caused by Ozempic side effects.

Given common questions of fact and law raised in the cases, a group of plaintiffs filed a motion to centralize all Ozempic gastroparesis lawsuits on December 1, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer claims brought throughout the federal court system to the U.S. District Court for the Western District of Louisiana, for coordinated management before one judge during discovery and pretrial proceedings. The panel will hear oral arguments on the motion later this month.

While the motion indicates there are currently less than two dozen cases filed in different U.S. District Courts, Ozempic gastroparesis lawyers are currently investigating more than 10,000 additional claims that may be filed in the coming months and years.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

If an MDL is established, the lawsuits will be transferred to wherever the U.S. JPML centralizes the pretrial proceedings. However, if the parties fail to negotiate Ozempic settlements for gastroparesis injuries during the MDL proceedings, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.