The European Medicines Agency initiates investigation into Novo Nordisk’s diabetes treatment Ozempic and weight-loss drug Saxenda, following concerns of suicidal thoughts raised by Iceland’s health authority
In response to three reported instances of patients contemplating suicide or self-harm, the European Medicines Agency (EMA) has initiated an investigation into Novo Nordisk’s diabetes treatment Ozempic and Saxenda, a weight-loss medication. The cases were initially highlighted by Iceland’s health authority.
The Icelandic Medicines Agency’s report of adverse effects has led an EMA safety committee to scrutinize Ozempic, which has the active ingredient semaglutide, and Saxenda, in relation to two instances of suicidal thoughts. Additionally, a patient using Saxenda, a former and less potent weight-loss medication by Novo that contains liraglutide, reported contemplations of self-harm, according to the agency.
The EMA’s investigation primarily focuses on medicines containing semaglutide or liraglutide. Novo’s weight loss medication Wegovy, which has seen a surge in demand in the United States, contains semaglutide. The announcement of this review followed the regulator’s identification of a potential thyroid cancer safety risk associated with several Novo products containing semaglutide. Neither of the drugs list suicidal thoughts as a side effect in their EU product information.
However, the prescribing instructions for Wegovy in the United States recommend monitoring patients for suicidal ideation or behavior.
According to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard, since 2018 there have been at least 60 reports of suicidal ideation associated with semaglutide use by patients or their healthcare providers. Additionally, the FAERS has recorded at least 70 such reports since 2010 from users of liraglutide or their healthcare providers. The FDA notes that these reports are unverified and the presence of a report doesn’t inherently establish causality.
Continual monitoring of drug safety throughout their lifecycle is undertaken by the FDA. While Wegovy’s trials didn’t suggest an increased risk of suicidal behavior, the drug’s label does carry a warning for such behavior and ideation due to risks identified with other weight management medications, as stated by the regulator.
While only three cases have been reported by Iceland’s regulator, the issue of suicidal ideation associated with weight-loss drugs is delicate and has previously hindered the pharmaceutical industry’s development of profitable weight-loss medications.
In clinical trials for Ozempic and Saxenda, Novo specifically excluded individuals with a history of psychiatric disorders or recent suicidal behavior.
Sanofi’s Acomplia, which failed to secure U.S. approval, was withdrawn from the European market in 2008 after being associated with suicidal ideation.
Acomplia functioned by altering portions of the nervous system regulating appetite. Conversely, new weight-loss medications like Wegovy regulate appetite by mimicking a gut hormone, avoiding direct interference with brain chemistry.
Orexigen Therapeutics’ Contrave and Vivus Inc’s Qsymia, weight-loss pills approved in the U.S. in 2014 and 2012 respectively, carry warnings on their labels regarding increased risk of suicidal thoughts.
On Monday, the EMA announced that it would consider expanding the review to encompass other drugs from the same class, known as GLP-1 receptor agonists. The ongoing thyroid cancer investigation by the EMA encompasses all GLP-1s.
Penny Ward, a pharmaceutical medicine visiting professor at Kings College in London and an expert on EU drug safety monitoring, speculated that the investigation’s most probable outcome would be a modification to the drug’s EU label to include a warning of the potential side effect of suicidal thoughts.
Considering Legal Action Following a Suicide Attempt or Loss While on Prescription Medications
The adverse effects of prescription drugs can sometimes lead to severe consequences, such as attempted suicides or even the loss of a loved one. If you or someone close to you has been affected by such incidents while taking Ozempic, Saxenda, or other similar medications, it’s crucial to understand your legal options. There are principally two kinds of lawsuits that can be considered in such situations: product liability and wrongful death suits.
Product Liability Lawsuits
A product liability lawsuit claims that a product is defective and has caused harm to a consumer. In the context of prescription medications, these defects could stem from inadequate warnings or instructions, design defects, or manufacturing defects. If a drug is found to have inadequate warnings about potential side effects like suicidal thoughts, a manufacturer could be held liable for any harm that ensues. This is particularly relevant when the patient or their family was not fully informed about the risks.
Wrongful Death Lawsuits
If a loved one has tragically passed away due to suicide while taking these medications, a wrongful death lawsuit may be pursued. These lawsuits seek compensation for the survivors’ loss, including lost wages from the deceased, lost companionship, and funeral expenses.
Why You Need a Lawyer
The legal landscape surrounding prescription medication lawsuits is complex and requires a thorough understanding of both medical and legal intricacies. An experienced Ozempic lawsuit attorney from our national product liability law firm can help you navigate this complex process, evaluate the strength of your case, and advocate for your rights in court.
Why Choose Parker Waichman LLP?
Parker Waichman LLP is a highly respected law firm that focuses its practice to product liability lawsuits, serving clients across all 50 states. They have a proven track record in handling cases involving defective drugs and medical devices, having secured over $2 billion in settlements for their clients.
Their team of dedicated legal professionals thoroughly investigate each case, ensuring every client receives personalized attention and high-quality legal representation. They understand the pain and hardship that adverse drug effects can inflict and are committed to holding negligent manufacturers accountable.
If you or a loved one have suffered from suicidal thoughts or actions while taking prescription medication like Ozempic or Saxenda, consider reaching out to Parker Waichman LLP for a free, confidential consultation. Their compassionate and experienced legal team can provide you with the guidance and support you need during this challenging time.
You’re Not Alone – We’re Here to Help
At Parker Waichman LLP, we understand the immense pain and distress that losing a loved one or enduring a suicide attempt due to a prescription medication can cause. Our hearts go out to you during this incredibly challenging time, and we want you to know that we’re here to fight for the justice you deserve.
Reach out to us today by calling our toll-free number 1-800-YOUR-LAWYER for a free, confidential consultation. You’ll have the opportunity to share your experience with our empathetic legal team and learn about the best steps forward for your situation.
Remember, you won’t pay a cent unless we win your case. We firmly believe in holding negligent pharmaceutical companies accountable, and our no win, no fee structure underlines this commitment.
In your darkest hour, let us provide the legal support you need. Call 1-800-YOUR-LAWYER (1-800-968-7529) today, or visit our website to fill out a free case evaluation form. Allow us the privilege of standing up for you and your loved ones – because you deserve nothing less than justice and peace of mind.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous medications such as Ozempic. For your free consultation, contact our national Ozempic Lawsuit Law Firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
