Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction
In September 2023 the Ozempic (semaglutide) drug label was updated to inform doctors and patients that adverse reaction reports concerning ileus, a gastrointestinal disorder, have been received for semaglutide during the time since Ozempic was first approved by the FDA in 2017. This September 2023 Ozempic label change can be found in part "6.3 Postmarketing Experience" of the Ozempic Full Prescribing Information document ("Revised: 9/2023" version).
Ileus is a medical condition similar to intestinal obstruction but with some distinctions. Essentially, for ileus the bowel does not work correctly, but there is no structural problem causing it; while for intestinal obstruction there is a partial or complete blockage of the bowel.
Intestinal obstruction is a blockage that keeps food or liquid from passing through your small intestine or large intestine (colon)....
Intestinal pseudo-obstruction (paralytic ileus) can cause signs and symptoms of intestinal obstruction, but it doesn't involve a physical blockage. In paralytic ileus, muscle or nerve problems disrupt the normal coordinated muscle contractions of the intestines, slowing or stopping the movement of food and fluid through the digestive system.
Getting back to the September 2023 Ozempic label change adding the ileus adverse reaction reports, this September 28, 2023, FiercePharma article, "Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder", provides some contextual information:
While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.
One came last week, when the FDA revealed that it has updated the label for Novo’s Ozempic, warning of the potential of intestinal blockage.
The condition, known as ileus, can be life threatening and is already listed as a potential side effect on the labels of Eli Lilly’s diabetes drug Mounjaro and Novo’s weight-loss therapy Wegovy, which is the same formulation as Ozempic, just in a higher dose.
On the FDA’s Adverse Events Reporting System (FAERS) public dashboard, the agency has tracked 33 reports of ileus from GLP-1 users, with two deaths....
The risk of ileus was cited earlier this year by a group of Chinese scientists. They wrote that the use of GLP-1 drugs may cause continuous increases in intestinal length, causing it to “become as inelastic and fibrotic as a loose spring.” The possibility of having an intestinal blockage peaks after a year and a half of use, the researchers said, which is longer than the duration of most of the clinical studies involving GLP-1 therapies.
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And we learn about the number of Ozempic gastrointestinal side effects, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 from this September 28, 2023 article, "FDA Adds New Warning for Ileus to Semaglutide (Ozempic) Label", published September 28, 2023, on the HCPLive® website:
According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.
Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of [Ozempic], with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.
We will watch for more significant developments concerning gastrointestinal conditions such as ileus associated with Ozempic, Rybelsus, and Wegovy, semaglutide-containing drugs from Novo Nordisk.
In the meanwhile, we continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, or Wegovy and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.