FDA warns of potential side effects from diabetes drug Ozempic, updates labels.

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.

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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.

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.

Ozempic works by stimulating insulin production and ‌reducing ⁤glucose production in the liver, effectively lowering blood‌ sugar levels.

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.

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.