FDA adds intestinal blockage warning to Ozempic label

FDA adds intestinal blockage warning to Ozempic label

FDA Adds Warning on Diabetes Drug Ozempic Label in Response to Intestinal Blockage Reports

ozempic

Sept. 28, 2023 – In a recent announcement, the Food and Drug Administration (FDA) revealed that it will be modifying the label for the diabetes drug Ozempic due to reports of potential intestinal blockages. The condition, known as “ileus,” has been reported in 18 cases among individuals using Ozempic.

The FDA has received over 8,500 reports of gastrointestinal issues associated with medications similar to Ozempic, including the weight loss drug Wegovy. Out of these reports, 33 cases mention ileus, which includes two deaths. It is worth noting that the active ingredient in Ozempic, Wegovy, and another popular weight loss drug called Mounjaro is semaglutide.

Semaglutide is a medication that mimics the hormone glucagon-like peptide-1 (GLP-1), which targets the brain regions responsible for regulating appetite and food intake. While the labels for Mounjaro, Ozempic, and Wegovy already include a mention of possible delayed stomach emptying, the FDA refrained from directly linking Ozempic to intestinal blockages.

The FDA statement clarified, “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.” Nonetheless, a similar warning regarding the risk of intestinal blockages is already present on the labels for Mounjaro and Wegovy.

Interestingly, individuals who take semaglutide often experience significant weight loss, typically amounting to around 15% of their body weight. This effect is particularly valuable for those struggling with obesity and related health conditions. It is important to remember, however, that healthcare providers should monitor the potential side effects associated with the medication.

The label update for Ozempic comes amid a lawsuit filed by a woman from Louisiana. Her case alleges severe injury resulting from the use of Mounjaro and Ozempic. The lawsuit contends that the pharmaceutical companies failed to disclose the drugs’ potential risks, which include vomiting and diarrhea due to inflammation of the stomach lining, as well as the condition known as gastroparesis, or stomach paralysis.

In light of these developments, it is critical for individuals taking Ozempic, Wegovy, or Mounjaro to remain vigilant and consult their healthcare providers if they experience any unusual symptoms or side effects. The FDA’s label update serves as a reminder of the importance of monitoring and managing medication usage, ensuring both the benefits and risks are carefully weighed.

label change

Key Points:

  • The FDA is modifying the label for the diabetes drug Ozempic to include a warning about potential intestinal blockages, following reports of ileus in 18 cases.
  • Over 8,500 reports of gastrointestinal issues have been received by the FDA related to medications like Ozempic and Wegovy, with 33 mentioning ileus and two deaths.
  • Semaglutide, the active ingredient in Ozempic, Wegovy, and Mounjaro, mimics a hormone that regulates appetite and food intake.
  • Although the label update does not directly link Ozempic to intestinal blockages, warnings about this risk are present on the labels for Mounjaro and Wegovy.
  • A subsequent lawsuit alleges severe injury resulting from the use of Mounjaro and Ozempic, claiming inadequate disclosure of possible side effects.
  • Monitoring and consulting healthcare providers for any unusual symptoms or side effects is essential for individuals taking Ozempic, Wegovy, or Mounjaro.