FDA Updates Ozempic Label to Include Intestinal Blockage Warning
In response to increasing concerns, the US Food and Drug Administration (FDA) has taken the step to amplify warnings concerning the diabetes medication Ozempic. The agency, on September 28, 2023, introduced a new warning on Ozempic’s label about the risk of intestinal blockages or “ileus”. This move follows 18 reported cases of ileus in patients consuming the drug.
The overall landscape of medications containing the active ingredient semaglutide, such as Ozempic, Wegovy (used for weight loss), and another prominent weight-loss drug Mounjaro, has seen over 8,500 gastrointestinal complication reports. Out of these, 33 cases have highlighted the presence of ileus, resulting in two unfortunate fatalities.
Semaglutide’s action mechanism is intriguing; it emulates a hormone known as glucagon-like peptide-1 (GLP-1) that influences areas of the brain responsible for appetite and food consumption. As a result, significant weight reduction, often equating to around 15% of body weight, has been noticed in those consuming semaglutide-infused drugs. Notably, Mounjaro, Ozempic, and Wegovy’s existing labels already indicate the potential of delayed stomach emptying.
However, the FDA, exercising caution, has not conclusively confirmed a direct correlation between Ozempic and the risk of intestinal blockages. The agency remarked that since these adverse effects are communicated on a voluntary basis from a variable population size, it’s challenging to conclusively gauge their occurrence rate or affirm a direct relationship with the drug. Interestingly, the alert for the possibility of intestinal blockages had already been a part of the labels for Mounjaro and Wegovy.
This renewed attention was precipitated by a lawsuit in August, wherein a Louisiana woman alleged she experienced severe side effects after consuming Mounjaro and Ozempic. She contended that the drug manufacturers didn’t adequately inform users about potential risks, such as stomach inflammation leading to vomiting and diarrhea, and the possibility of gastroparesis or stomach paralysis.
Filing a Lawsuit to Recover Potential Damages
The growing concerns regarding drugs such as Ozempic open up possible legal options for those who believe they have been harmed by them. Those believing they’ve been adversely affected due to undisclosed or insufficient warnings on drug labels can contemplate filing a product liability lawsuit. In such legal scenarios, plaintiffs might be entitled to recover damages not just for medical bills, but also for pain, suffering, loss of income, and in grave situations, wrongful death.
It’s essential to recognize that pharmaceutical manufacturers bear a profound responsibility to ensure that their products are safe for consumption and come with comprehensive warnings about potential side effects. If a company falls short in this duty, they can be held accountable for any resultant harm.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
If you or a loved one has encountered complications after taking medications like Ozempic, you mustn’t remain silent. Parker Waichman LLP, a distinguished national product injury law firm, is here to guide you. They offer a complimentary consultation, ensuring that victims understand their rights and the possible legal course of action. Make your voice heard and potentially safeguard others from similar predicaments. Contact Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) for a thorough evaluation of your case.
.svg){kind=small}
.avif)
.avif)