Legal Battles and Health Risks: The Controversy Surrounding Ozempic
Updated
There are at least 55 lawsuits against Novo Nordisk for their diabetes drug, Ozempic that has been frequently prescribed off-label as a “miracle” weight loss drug. A multi-district legislation has moved all federal Ozempic lawsuits into the Eastern district of Pennsylvania under Judge Gene Pratter. The current lawsuits have claims of gastrointestinal issues, the most severe of which is gastoperesis, also known as stomach paralysis. Intestinal blockage is another common gastrointestinal issue that has been linked to the drug. Novo Nordisk attempted to have some of these cases dismissed on the basis that these side effects are well documented within the approval by the FDA.
The pharmaceutical manufacturer attempted to gain immunity from lawsuits since the FDA approved-label acknowledges the side effect. A Daily Mail report referred to a woman who will experience life-long diarrhea as a result of side effects from using Ozempic. Another woman said she nearly lost her job for being so sick she could not go to work for the day. When she did attempt to go to work, she would soil her clothes. She would bring a change of clothing every day she went to work.
Daily Mail spoke with attorney Cameron Stephenson, who has approximately 100 clients with gastroparesis from taking Ozempic. Stephenson and his law office are investigating 1,000 more cases. Right now, the lawsuits are only focusing on gastrointestinal issues, although anecdotal reports of suicidal ideation have been reported.
The Food and Drug Administration’s Adverse Event Reporting System (FAERS) had 262 reports regarding suicidal ideation or depression. Among those claims are 20 reports of suicide. The FDA has been investigating the link between suicidal ideation and semaglutide drugs, including Ozempic and Wegovy. They have not found a causal association between semaglutide drugs and depression.
The Wegovy drug insert says to warn patients about potential worsening of suicidal ideation, depression, or changes in mood. Meanwhile, a new NIH study was released that indicates semaglutide decreases suicidal ideation. Novo Nordisk also claims that there was no suicidal ideation witnessed in the clinical trials for Ozempic.
The FDA recently approved Wegovy to reduce risk of serious heart problems. The FDA label for Wegovy states heart rate increases are positively associated with use of the drug. In the animal study for Wegovy, the FDA approval states the following: “In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.”
The HighWire has reported on suicidal ideation from Ozempic, lawsuits, and European health agency investigations. Jeffrey Jaxen also reported on the Highwire regarding suicidal ideation and stomach paralysis.
The lawsuits against Novo Nordisk are moving forward while more alleged victims are piling up in the queue. Ozempic is under FDA investigation for hair loss and suicidal ideation over a year after investigating the drug for intestinal blockages. The initial reports indicate the FDA doesn’t see a safety issue with the drug despite hundreds of FAERS (FDA Adverse Event Reporting System) submissions linking the drug to suicidal thoughts.
Ozempic does not list a warning of suicidal thoughts. Novo Nordisk’s other semaglutide drug for weight loss, Wegovy, does say to tell your medical provider if you have or have had depression, suicidal thoughts, or mental health issues.