FDA To Remove Suicide Risks From GLP-1 Side Effects Warnings

Investigators found no increased suicide risks after reviewing nearly 100 previous clinical trials.

Federal drug regulators say a review of the potential side effects of popular weight loss medications like Wegovy and Zepbound did not show any increased risk of suicide or suicidal ideations among users, leading to a request that manufacturers remove information about those risks from the drugs’ labels.

The U.S. Food and Drug Administration (FDA) issued a drug safety communication on January 13, announcing that it has requested Novo Nordisk and Eli Lilly to change the labels on Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirezepatide) to remove current warnings about the risks of suicide.

All three drugs belong to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, which also include popular medications like Ozempic, Mounjaro and Trulicity. However, while those drugs are generally prescribed to treat diabetes, Wegovy and Zepbound, and to a lesser degree Saxenda, are all primarily used as weight loss treatments, according to the FDA.

GLP-1 diabetes medications have seen a sharp rise in popularity in recent years. However, along with surging sales have come concerns over certain side effects being reported by users, particularly involving GLP-1 gastrointestinal problems. These include gastroparesis, or stomach paralysis, and the risk of intestinal obstruction, among others. Simultaneously, there are also an increasing number of GLP-1 vision loss lawsuits being filed against manufacturers, with Ozempic being named most frequently by plaintiffs.

Amid growing side effect concerns, Novo Nordisk and Eli Lilly face nearly 3,000 Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits filed nationwide over claims that the manufacturers failed to warn consumers and the medical community about the actual risks of the drugs.

The FDA safety communication is one of the few recent actions to declare the drugs safer than originally believed. At the time of their release, all three medications carried suicide risk warnings in the Warnings and Precautions section of the label. This was due to the general trend of suicidal ideation and behavior (SI/B) problems among a variety of weight loss treatments, which were assumed to be true for GLP-1 medications as well.

According to the agency, it commenced a safety review of suicidal ideation concerns linked to GLP-1 use as a weight loss drug in July 2023, following reports of suicidal ideation and self-harm attempts. The findings were published in January 2024 and indicated the FDA did not find a link between the use of Saxenda, Wegovy or Zepbound and an increase in suicidal ideations.

Conducting a meta-analysis of existing science, the FDA discovered there were 91 placebo-controlled GLP-1 medication trials involving 106,910 patients. The results showed no increased risk of SI/B, anxiety, depression, irritability or psychosis.

“Our review concluded that the totality of these studies does not support a causal relationship between the use of GLP-1 RAs and the occurrence of SI/B. Therefore, consistent with these findings, FDA is requesting that application holders remove information regarding the risk of SI/B from the labeling of GLP-1 RA medications that currently include such language.”

– FDA Drug Safety Communication

The FDA requests that any serious problems experienced by those taking the medications be reported to the FDA’s MedWatch adverse event reporting program.

GLP-1 Lawsuits

All federal GLP-1 gastroparesis lawsuits and vision loss lawsuits have been centralized into two separate multidistrict litigations (MDLs) in the Eastern District of Pennsylvania, where U.S. District Judge Karen Marston is overseeing pretrial proceedings, coordinated discovery and plans to prepare a group of representative claims to serve as early test “bellwether” trials.

After resolving some remaining cross-cutting issues, Judge Marston is expected to direct the parties to select several representative Ozempic gastrointestinal injury lawsuits for early bellwether test trials, which will help the parties gauge how juries are likely to respond to evidence and testimony that would be presented throughout the litigation.

Although at a much earlier stage, it is expected that she will approach the vision loss claims in a similar fashion.

While the outcomes of these bellwether trials are not binding on other claims, they could help the parties reach a GLP-1 settlement agreement that would avoid the need for each individual case to be sent back to its originating district for costly individual trials in the future.

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