Labels Updated for Diabetes Drug Ozempic to Include Intestinal Disorder
The FDA has recently updated the labels for the diabetes drug Ozempic to acknowledge the occurrence of a condition that affects the normal functioning of the intestines in some users. This label update was made on September 22.
The updated label now clearly states that a gastrointestinal disorder called ileus has been reported as an adverse reaction to the drug. Ileus is a temporary disruption of the normal muscle contractions in the intestines, which can result in improper food passage and waste movement through the body.
The updated label also includes a Disclaimer stating that due to the voluntary reporting of these reactions from an uncertain population size, it is difficult to estimate their frequency or establish a direct link to the drug.
Ileus is more likely to occur in individuals who have undergone abdominal or pelvic surgery, have infections, or have certain muscle and nerve disorders like Parkinson’s disease.
Those taking medications that affect muscles and nerves, such as antidepressants and opioids, are also at a higher risk of developing this digestive disorder.
Common symptoms of ileus include abdominal cramps, loss of appetite, constipation, vomiting, and an inability to pass bowel movements.
The anti-diabetic medication Ozempic (semaglutide) made by Danish pharmaceutical company Novo Nordisk, in Paris on Feb. 23, 2023. (Joel Sage/AFP via Getty Images)
Ozempic Popularity Soars
The label update comes at a time when Ozempic, manufactured by Novo Nordisk, has gained significant popularity as an off-label weight loss aid. This surge in demand has led to widespread shortages of the drug.
A similar diabetes drug called Mounjaro, made by Eli Lilly, suppresses appetite and reduces food intake by targeting the body’s receptors for the hormones GIP and GLP-1.
Both Ozempic and Mounjaro have been named in a lawsuit filed by a woman in Louisiana. She claims that the manufacturers failed to adequately warn users about the severe gastrointestinal problems these medications can cause, including gastroparesis, which is similar to ileus.
The lawsuit alleges that the manufacturers downplayed the severity of these gastrointestinal events and did not warn about the risk of gastroparesis or gastroenteritis.
The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)
Semaglutide Adverse Reactions
The lawsuit highlights that both Novo Nordisk and Eli Lilly acknowledge gastrointestinal events as known side effects of the GLP-1 class of drugs. However, they allegedly downplayed the severity of these events and failed to warn about the risk of gastroparesis and gastroenteritis.
Gastroparesis, which is also caused by diabetes itself, is a condition characterized by delayed stomach emptying.
The lawsuit further claims that the manufacturers did not mention the risks of severe gastrointestinal events when they received FDA approval for these drugs.
Lawyers for the woman state that hundreds of other users have reported similar health issues and are considering legal action against the companies.
According to FDA data, there have been 87 reports of adverse reactions related to semaglutide medications, including Ozempic, this year alone. Since 2018, there have been over 400 reports, with approximately 250 of them being gastrointestinal disorders like ileus.
“Although ileus and gastroparesis have some similarities, they are not the same,” said FDA spokeswoman Chanapa Tantibanchachai in a statement to CBS News.
Tantibanchachai added that while the labels for Ozempic and similar drugs already mention “delayed gastric emptying” as a possible side effect, the FDA is closely monitoring real-world reports of gastroparesis and related terms.
The FDA will take appropriate action if any new safety concerns arise after a thorough review of available data.
The Epoch Times has reached out to the FDA for further comment.
What steps can regulatory agencies like the FDA take to strengthen oversight and ensure thorough testing of drugs for potential adverse effects
And Eli Lilly failed to adequately warn users about the potential adverse reactions of their diabetes drugs. In addition to ileus and gastroparesis, other adverse reactions associated with semaglutide, the active ingredient in Ozempic, include pancreatitis, kidney damage, thyroid cancer, and severe allergic reactions.
The FDA’s label update for Ozempic is a step in the right direction towards ensuring that users are informed about the potential risks and side effects of the drug. However, it is important for both manufacturers to take responsibility and provide clear and accurate information about the risks associated with their medications.
Patients who are taking Ozempic or similar drugs should be aware of the potential symptoms of ileus and other gastrointestinal disorders. If they experience any of these symptoms, they should seek medical attention immediately. It is also crucial for healthcare providers to monitor patients taking these medications for any signs of adverse reactions and to educate them about the possible risks.
Furthermore, it is essential for regulatory agencies like the FDA to strengthen their oversight and ensure that pharmaceutical companies thoroughly test their drugs for potential adverse effects before they are approved for use. This will help to reduce the occurrence of such adverse reactions and protect the health and well-being of patients.
In conclusion, the FDA’s label update for Ozempic to include the acknowledgement of ileus as an adverse reaction is an important development in ensuring patient safety. However, it also highlights the need for better regulation and transparency in the pharmaceutical industry. Manufacturers must provide accurate and comprehensive information about the potential risks of their medications, and regulatory agencies must enforce strict guidelines to protect the health and well-being of patients.
Now loading...