The makers of several effective drugs to treat type 2 diabetes are facing lawsuit because doctors also prescribe them for weight loss, which most of the drugs have not been approved for.
Novo Nordisk, the maker of Ozempic and Wegovy — which is approved for weight loss and contains higher amounts of the active ingredient in Ozempic, semaglutide — have been sued by several people over extreme side effects the users say they were not warned about, British tabloid The Daily Mail reported.
More than a dozen lawsuits have been filed since November against the drug maker, the Daily Mail said, and most of the patients say they suffer from gastroparesis, or paralysis of the stomach. The condition can be life threatening.
Eli Lilly, which manufactures the similar drug Mounjaro, faces at least 10 lawsuits. Mounjaro is another drug that is not approved for weight loss but is nevertheless prescribed for that use frequently. Mounjaro’s active incredient, tirzepatide, has been approved for weight loss under the name Zepbound.
In one case, a woman who used both Ozempic and Mounjaro for weight loss, despite their not being approved for that purpose, said she was diagnosed with gastroparesis and vomited so much some of her teeth fell out.
Another woman said she was diagnosed with a “life-threatening bowel injury” after using Ozempic. Doctors told her she would be in pain “for the rest of her life” and would “never have a solid bowel movement again.”
A third case, brought by a woman who used Wegovy — which is approved for weight loss” said she was diagnosed with “severe gastroparesis” and was hospitalized after being constipated for a week.
Dozens of cases are under review and could be combined into a multidistrict litigation (MDL).
“There’s no doubt in my mind that there are going to be thousands of cases that will be filed in the MDL over time,” said Cameron Stephenson, an attorney whose firm is currently representing about 100 clients and is reviewing hundreds more cases.
Stephenson said that there is “no doubt” the drugs are effective but that the potential side effects must be on a warning label.”
The attorney also said he suspects that the drug companies sought approval of their products for diabetics with the intention of pushing the off-label weight loss use.
“I expect to see documents to suggest that there was going to be off-label marketing and promotion outside of diabetes,” he said.
“I expect that the clinical trials and the things that they did in the various phases to come up with these drugs before they filed with the FDA, I think that they’re going to show that there was a risk of gastroparesis, and it’s not in the label, and it’s still isn’t in the label.”
Novo Dordisk told The Daily Mail that the allegations against it are “without merit.” Both it and Eli Lilly said they would defend their products “vigorously.”
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