FDA adds ‘Blocked Intestines’ as potential side effect to Ozempic and other drug warning labels.
Ozempic Diabetes Treatment Now Lists Clogged Intestines as Side Effect
OAN’s Brooke Mallory
3:33 PM – Thursday, September 28, 2023
The diabetic treatment Ozempic, which has gained popularity for not only diabetes but weight loss too, now acknowledges clogged intestines as a potential side effect on its label.
The modification follows the approval of several product revisions by the Food and Drug Administration (FDA) from pharmaceutical company Novo Nordisk.
Ozempic now joins other medicines in the popular family of drugs known as GLP-1 agonists in acknowledging an increase in complaints of clogged intestines, also known as ileus.
Wegovy, a Novo Nordisk semaglutide injectable used for weight reduction, as well as Mounjaro, an Eli Lilly diabetic treatment, also acknowledge reports of ileus on their labels.
However, the FDA has not directly attributed the medicines to the potentially fatal disease.
“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,” the label reads.
According to statistics provided by the government until June 30th, the FDA has received 8,571 reports of gastrointestinal problems following the use of semaglutide drugs, which include Ozempic and Wegovy.
The FDA’s dashboard documents 33 cases of semaglutide users, including two fatalities, with ileus identified as a side effect.
A lawsuit has been filed against Novo Nordisk and Eli Lilly alleging that the drugs can cause gastroparesis, or stomach paralysis, which obstructs food from entering the small intestine.
“Although there is some overlap in the terms, ileus and gastroparesis, they are not synonymous,” FDA spokesperson Chanapa Tantibanchachai said in a statement.
Tantibanchachai pointed out that the labels of drugs like Ozempic already mention that they cause “delay of gastric emptying.” However, the FDA is monitoring reports of gastroparesis and related terms in medication usage.
“If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data,” Tantibanchachai said.
Novo Nordisk has stated that they will acknowledge the update to Ozempic’s label and are working closely with the FDA to monitor the safety of their medicines.
“Novo Nordisk stands behind the safety and efficacy of Ozempic and all of our medicines when used consistent with the product labeling and the approved indications. For Ozempic, the most commonly reported side effects include: nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation,” the company said in its statement.
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What actions should patients take if they notice any unusual symptoms or side effects while taking Ozempic or any other GLP-1 agonist medication
Ng, diarrhea, abdominal pain, and constipation,” the company said in a statement.
Patients who are currently taking Ozempic or any other GLP-1 agonist medication are advised to discuss any concerns or symptoms with their healthcare provider.
It is important to note that while clogged intestines, or ileus, is listed as a potential side effect, it does not mean that every patient will experience this condition. As with any medication, the benefits and risks should be carefully considered by both the prescribing healthcare professional and the patient.
Furthermore, it is crucial for patients to be aware of any changes in their health and to report any unusual symptoms or side effects to their healthcare provider immediately.
The FDA continues to monitor the safety of GLP-1 agonists and other medications through post-marketing surveillance and encourages healthcare professionals and patients to report any adverse events.
As the use of Ozempic and similar medications continues to grow, it is essential for pharmaceutical companies and regulatory agencies to prioritize patient safety and ensure that necessary precautions and warnings are in place.
Ultimately, the responsibility lies with healthcare professionals and patients to weigh the potential benefits and risks of medication and make informed decisions. Open communication and regular monitoring of patients’ health are vital in ensuring the best possible outcomes.
The recent update to Ozempic’s label regarding clogged intestines as a potential side effect serves as a reminder of the importance of continuous evaluation and reporting of medication safety. It also underscores the need for further research and awareness surrounding the risks and benefits of GLP-1 agonists and other diabetes treatments.
With ongoing efforts in monitoring and regulation, it is hoped that the medical community can provide safe and effective treatments for diabetes, while minimizing the occurrence of adverse events and promoting patient well-being.
" Conservative News Daily does not always share or support the views and opinions expressed here; they are just those of the writer."
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