Side Effects and Off Label Use of Ozempic
Doctors have been concerned about off-label use of Ozempic due to the risks of suffering gallbladder disease in connection with the drug. If you suffered harm to your gallbladder or other injuries and suspect they are the result of taking Ozempic, you should call the experienced Chicago-based product liability lawyers of Moll Law Group. Billions have been recovered in dangerous drug lawsuits with which we’ve been involved across the state.
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The prescription drug Ozempic is a liquid inside pre-filled disposable pens that is used to control the blood sugar of adult type 2 diabetes patients. Semaglutide is the active ingredient of Ozempic. There is no generic form provided of the drug.
Ozempic is injected beneath the skin. Generally, adults have been advised to combine Ozempic with lifestyle improvements. The drug also lowers the chance of suffering stroke or heart attack. However, the drug is not recommended for type 1 diabetics, those with diabetic ketoacidosis, or those who have had pancreatitis. And Ozempic’s connection to gallbladder trouble may make it risky to use.
Unfortunately, by December 31, 2021, consumers had reported more than 10,000 adverse events to the FDA in connection with this drug. The FDA Adverse Reporting System (FAERS) codes all reported diagnoses of gallstones believed to arise from the drug as severe adverse events. Gallstones were reported in 1.5% and 0.4% of 0.5 mg and 1 mg semaglutide-treated patients, respectively.
Treatment was discontinued because of 4 acute gallbladder events. These events involved hydrocholecystitis, cholelithiasis, and jaundice with semaglutide 0.5 mg, along with 1 bile duct stone in a case involving a placebo. In Ozempic clinical trials, around 90% of patients reported cholelithiasis, which was coded as serious, since it demands removal of the gallbladder. Ozempic could increase patients’ chances of developing gallstones or other acute gallbladder disease.
Ozempic has an FDA boxed warning because the drug has been demonstrated to trigger thyroid tumors and thyroid cancer in animals. It is unknown whether Ozempic could produce either tumors or cancers in humans, but generally, those with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 shouldn’t take the drug.
Manufacturers can be held accountable for harm to patients or consumers in a product liability lawsuit when the drugs they make or distribute are defective in terms of their design, manufacturing, or marketing. Generally, marketing defects involve failures to warn of dangerous side effects.
In many cases, the learned intermediary doctrine applies to dangerous drug cases. Under this doctrine, a drug manufacturer fulfills its duty of care when it gives all needed information about side effects and hazards to a “learned intermediary,” such as a doctor who prescribes the medication. For that reason, it is crucial to fully investigate the circumstances and hold doctors accountable for harm when appropriate, as well.
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If you or your child was injured by Ozempic, you should contact the seasoned dangerous drug lawyers of Moll Law Group about whether you have a claim. We represent plaintiffs across the country. Please complete our online form or give us a call at 312.462.1700.