FDA Advises Against Use of Weight Loss Drugs Wegovy and Ozempic During Pregnancy
As weight loss medications like Wegovy and Ozempic rise in popularity across the United States, concerns are emerging about their safety, particularly for women who are pregnant or trying to conceive. The U.S. Food & Drug Administration (FDA) and Denmark-based pharmaceutical company Novo Nordisk have issued warnings to this effect. Here’s what you need to know about the potential risks.
What Are Wegovy and Ozempic?
Wegovy and Ozempic are medications containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. These drugs mimic the effects of the GLP-1 hormone, which is naturally produced in the digestive system and signals feelings of fullness to the brain. While Ozempic was originally developed to manage diabetes, Wegovy received FDA approval as a weight loss medication in 2021.
FDA Warnings and Pregnancy Concerns
According to the FDA, semaglutide medicines like Wegovy and Ozempic could result in a range of pregnancy complications, including birth defects, low birth weight, and even miscarriages. These findings are based on animal studies, though they are still considered limited. As a result, the medications come with warning labels advising against their use during pregnancy.
Novo Nordisk’s Position
Novo Nordisk, the manufacturer of Wegovy and Ozempic, recommends that women discontinue semaglutide medication if they find out they are pregnant. The company also advises both female and male partners to cease taking the medication at least two months before planning a pregnancy due to the drug’s long half-life.
Case Study and Registry
In a New Drug Application study for Wegovy, a 17-year-old participant from Russia became pregnant and ceased medication intake at approximately seven weeks of gestation. Despite delivering a full-term baby without congenital anomalies, health issues emerged within the infant’s first month, including intrauterine growth retardation and drug exposure in utero. To monitor the outcomes more closely, Novo Nordisk has initiated a pregnancy exposure registry.
Other Risks and Side Effects
Aside from the risks to pregnant women and their unborn children, semaglutide medications also carry other potential health risks. These include gastroparesis (stomach paralysis) and cyclical vomiting, which are uncommon but associated side effects. In light of these adverse effects, legal actions against Novo Nordisk have commenced.
Post-approval, the FDA continues to monitor the safety of drugs like Wegovy and Ozempic. At present, they are under review for a serious risk of intestinal obstruction and gallbladder-related disorders.
While the weight loss benefits of drugs like Wegovy and Ozempic have appealed to many, they are not without risks, especially for pregnant women and those trying to conceive. It’s crucial to consult healthcare professionals for personalized medical advice, particularly when pregnancy is involved.
How to File a Lawsuit for Harm Caused by Wegovy or Ozempic
If you’ve experienced adverse health effects after taking the medications Wegovy or Ozempic, you may be contemplating legal action. Knowing how to navigate the legal system can feel overwhelming, especially when you’re already dealing with health concerns. This section provides a step-by-step outline to help you understand how to file a lawsuit for harm caused by these medications. While it’s crucial to consult legal and medical professionals for personalized advice.
Steps to File a Lawsuit
- Document Your Case – Gather all medical records, prescriptions, purchase receipts, and any correspondence with healthcare providers that pertain to your use of Wegovy or Ozempic. This documentation will serve as essential evidence to support your claims.
- Seek Medical Expertise – Consult medical professionals to diagnose and document any health issues you may have experienced as a result of taking the medication. Secure written statements that explicitly link your condition to the medication in question.
- Consult Our Legal Experts – Speak to one of our lawyers who handle product liability or pharmaceutical lawsuits. We will assess your case’s validity and guide you through the legal process. We offer this consultation at no cost or obligation to you.
- File the Initial Complaint – Your lawyer will draft a complaint outlining the basis of your lawsuit, which will be filed in the appropriate court. This document will specify the injuries you suffered, how the drug manufacturer is liable, and the type of damages you are seeking.
- Legal Procedures – After the complaint is filed, both parties will enter the discovery phase, exchanging documents and taking depositions to build their respective cases. Your lawyer may also file additional motions or engage in negotiations for a settlement.
- Trial or Settlement – If both parties fail to reach a settlement, the case will go to trial. Here, both sides will present their evidence, and a jury will decide the outcome. If the jury finds in your favor, you may be entitled to compensatory damages, and in some cases, punitive damages.
- Appeal – Either party has the right to appeal the court’s decision. An appeal can prolong the case but may result in a different outcome.
Types of Damages
If your case succeeds, you may be eligible for various types of damages:
- Compensatory Damages: These cover the direct costs incurred due to your injuries, including medical bills, lost wages, and future earnings.
- Non-Economic Damages: These are for pain and suffering, emotional distress, and loss of life quality.
- Punitive Damages: These are additional damages intended to punish the defendant for their negligence and deter them from similar conduct in the future.
Filing a lawsuit for harm caused by medications like Wegovy or Ozempic can be a complex and lengthy process, but taking the correct steps can greatly enhance your chances of a favorable outcome. Consulting experienced medical and legal professionals is crucial to navigate the intricate landscape of pharmaceutical lawsuits successfully.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective product. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation