March 2022 Ozempic Label Change About Risks of Gallbladder Disease is Just One Part of Legal Case Analysis
(Posted by Tom Lamb at Drug Injury Watch)
An Ozempic gallbladder disease warning was the subject of a March 2022 Ozempic drug label change by Novo Nordisk. Specifically, the following part was added to the Warnings and Precautions section of the Ozempic Prescribing Information document:
5.8 Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
As background, cholelithiasis is more commonly referred to as gallstones, and cholecystitis is inflammation of the gallbladder. A person may require gallbladder removal surgery if other treatments do not relieve the inflammation and pain from gallstones. Cholecystectomy is the medical term for gallbladder removal surgery.
While this March 2022 Ozempic gallbladder label change is a significant part of the legal analysis for a possible Ozempic gallbladder injury case, there are other important factors also. Figuring out if there might be a drug injury lawsuit to file against Novo Nordisk for your gallbladder disease is not as simple as whether your gallbladder diagnosis was made before or after that March 2022 "line-in-the-sand" date.
If you were prescribed Ozempic before April 2022 and had gallbladder removal surgery or were hospitalized for gallbladder disease, you should have an experienced drug injury lawyer review your possible Ozempic drug injury lawsuit.
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Generally, the legal basis for an Ozempic gallbladder injury case against the responsible drug company is that Novo Nordisk failed to warn doctors and patients about the risks of gallbladder diseases in a timely manner. In more detail, the contention is that, when one views the March 2022 Ozempic drug label change in the context of what they knew and when they knew it, this Ozempic gallbladder disease warning should have been added earlier.
Going from the law to medicine, Ozempic (semaglutide) is classified as a glucagon-like peptide-1 receptor agonist (GLP-1 RA). One's use of GLP-1 receptor agonists like Ozempic has been associated with an increased risk of bile duct and gallbladder diseases such as cholelithiasis.
The medical literature in support of why Novo Nordisk might of been "late" in warning about the risks of Ozempic-related gallbladder removal, for example, includes the following research:
- "Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus" (2016)
- "Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials" (2017)
- "Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials" (2020)
As pointed out in the title of this article, for the legal case analysis of an Ozempic drug injury lawsuit there are two important factors having to do with things other than when your gallbladder disease was first diagnosed or when you had gallbladder removal surgery.
First, what is the date (month/year) when your doctor prescribed Ozempic?
Second, was that Ozempic prescription for one month, a few months, or one year?
Of course, there are other considerations that we would discuss if you contact us about a possible Ozempic drug injury case involving gallbladder disease.
If we can be of assistance to you or someone you know, we encourage you to submit a Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ozempic gallbladder injury case. Either way, you will get Mr. Lamb’s impressions about your Ozempic case based on his more than 20 years of experience handling drug injury lawsuits.
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