FDA Database Reveals High Number of Serious Serious Adverse Events from Ozempic, Similar GLP1 Drugs

For this latest study, the team of Dr. Miller looked at reports submitted to the FDA’s Adverse Event Reporting System (FAERS) from the second quarter of 2005 to the first quarter of 2024. They found 287,201 adverse events related to the drug group.

According to research, older GLP-1s, such as Byetta and Victoza, have twice the risk of death than others in the group. However, the study also found almost three times the risk of serious adverse events associated with Ozempic, 30% increased risk for Wegovy users, and more than two and a half times the risk for Rybelus users, all of whom use semaglutide as the active ingredient.

Adverse events caused by Ozempic and similar new GLP-1s could affect younger patients and women, the researchers concluded. However, some of the drugs, such as Trulicity, Bydureon, Mounjaro and Zepbound, were linked to lower adverse event reporting rates than their competitors.

“This pharmacovigilance study using the FAERS database showed a safety profile of increased mortality and serious AE reporting associated with other GLP-1RAs, particularly liraglutide agents. the previously approved Byetta and Victoza,” the researchers concluded. “These findings highlight the importance of postmarketing surveillance to demonstrate the global safety profile of GLP-1RA drugs.”

Although the study did not quantify the types of adverse events reported, the researchers suggested that heightened awareness of the risk of gastrointestinal problems with Ozempic and Mounjaro led to more reporting among younger patients. in recent years.

The findings came days after a report in the Annals of Emergency Medicine, which warned emergency rooms to be better prepared to deal with Ozempic complications among patients, especially when necessary emergency sedation, which may increase the risk of vomiting or aspiration due to gastric retardation. the discharge caused by these drugs.

In June 2023, the American Association of Anesthesiologists (ASA) issued a warning about the dangers of Ozempic, recommending that doctors stop taking the drug before any elective procedure. However, this is not possible for emergency procedures, and many emergency rooms do not collect information about patients who may be taking medications.

August 2024 Ozempic, Mounjaro Lawsuits Update

Due to the widespread use of Ozempic, Mounjaro and other GLP1-RA drugs, thousands of people are now pursuing failure to warn manufacturers, each raising similar allegations and legal questions.

To help manage and coordinate pretrial proceedings, the United States Court of Appeals for the District of Columbia Litigation created GLP-1 RA drug cases earlier this year, filing lawsuits filed throughout the court system. of the district in the Eastern District of Pennsylvania, for discovery in connection with pretrial proceedings.

Last month, the judge presiding over the case issued a pretrial order allowing Ozempic’s new lawsuits to be filed in the federal MDL, which would avoid the delays associated with transferring claims from different courts. different districts across the country.

As part of the coordinated system of increasing cases, the teams are expected to select a small group of “bellwether” cases to prepare for the first days of the trial, which will help to measure the response of the courts. how in certain evidence and evidence will be. repeated throughout the claim.

However, if the parties are unable to negotiate a GLP1 settlement or other resolution for the case after any preliminary trials, each case may be returned to the Court. US District Court where it was originally filed for a different future trial date.