October 12, 2023
As CBS News first disclosed, the Ozempic label change reflects updates posted last week by the Food and Drug Administration—which acknowledged that some users experienced a condition known as “ileus,” which involves a blocking of the intestines.
“Because these reactions are reported voluntarily from a population of uncertain size,” the FDA pointed out in its update published last week, “it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”
Of the two semaglutide injections and Mounjaro, which affects the body in a similar way but uses the drug tirzepatide as its active ingredient, Ozempic is the last to reflect on its label that ileus has occurred in some of the drug’s users, CBS notes.
This latest label update follows an early August lawsuit from a Louisiana woman, who claims that the drugmakers behind the popular diabetes shots didn’t do enough to warn consumers about its “severe” gastrointestinal side effects.
In the suit, the woman alleges that Ozempic and Moujnaro both caused her to vomit so much that she lost teeth.”As a result of using… Ozempic and Mounjaro,” the suit reads, “Plaintiff was caused to suffer from severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating.”
In a statement to Fierce Pharma, a spokesperson for Ozempic and Wegovy maker Novo Nordisk said that these kinds of GI issues “are well-known side effects” of taking GLP-1 agonists, the class of drugs to which semaglutide belongs.
“For semaglutide,” the Danish company continued, “the majority of GI side effects are mild to moderate in severity and of short duration.”
Although ileus or intestinal blockages weren’t mentioned in that suit, these label updates could serve to protect Novo Nordisk and Eli Lilly, the maker of Moujnaro, from legal action—and, hopefully, will be taken into account by patients when weighing whether to take the increasingly-popular injections.
Research contact: @futurism