Diabetes and Weight-Loss Drug Ozempic Getting Scrutiny From European Drug Safety Regulator EMA
The popular diabetes and weight-loss drug Ozempic (semaglutide) has been linked to gallbladder diseases which may require gallbladder removal surgery. Other Ozempic side effects being investigated by the European Medicines Agency (EMA) are thyroid cancer and suicidal thoughts.
Starting with the gallbladder disease Ozempic side effects, we previously posted this Drug Injury Watch article, "Ozempic Gallbladder Injury Case Factors: When was the Ozempic Prescribed and For How Long?", which covered the March 2022 Ozempic label change that added warnings about the risks of gallbladder diseases.
Turning next to the possible association between Ozempic and thyroid cancer, we refer you to a June 22, 2023, Reuters news report, "Novo Nordisk says EMA raised safety signal on drugs including semaglutide", which includes this information:
A thyroid cancer safety signal was raised by the EU's drugs watchdog last month over several Novo Nordisk products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs, Novo Nordisk said. Such a signal from the EMA does not mean that the medicine is the cause of any reported adverse events.
"Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters....
Both EMA and its U.S. equivalent, the FDA, mention on Wegovy's label that semaglutide causes thyroid tumours in rodents but say the effects on humans are unknown. The FDA advises against taking Wegovy if the patient has a family history of thyroid cancer.
We point out that the current Ozempic Prescribing Information document (Revised: 03/2022) also has a warning about a risk of thyroid C-cell tumors.
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Lastly, we take a look at the more recently announced EMA investigation into Ozempic and suicidal thoughts. We begin with this July 10, 2023, Reuters news report, "E.U. investigates Ozempic and weight-loss drug Saxenda after reports of suicidal thoughts", from which we get the following:
The European Medicines Agency is investigating Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm....
The EMA’s investigation centers on medicines that contain either semaglutide or liraglutide. Novo’s obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide.
The review was announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo’s products containing semaglutide.
Suicidal thoughts are not listed as a side effect in the E.U. product information for either drug.
In the United States, however, prescribing instructions for Wegovy recommend that patients are monitored for suicidal thoughts or behavior.
According to the U.S. Food and Drug Administration Adverse Event Reporting System Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers.
For additional details we point out "Updated: European regulators investigating 150 reports of self-injury, suicide risk in patients taking Novo Nordisk meds for weight loss", which includes this July 2023 reporting by Endpoints News:
The European Medicines Agency is looking into about 150 reports of “possible cases of self-injury and suicidal thoughts” for weight loss patients who used Novo Nordisk’s semaglutide or liraglutide medicines.
The first three case reports were flagged by member agency Icelandic Medicines Agency, unveiled on Monday. The EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is now investigating.
“The case reports included two cases of suicidal thoughts, one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda,” the EMA said via email to Endpoints News, before issuing an updated statement today.
The EMA said its review of Ozempic, Saxenda and Wegovy began on July 3 and has now been extended to include other GLP-1 receptor agonists. This review is expected to conclude in November 2023, the regulator said in a statement.
The EMA updated statement referenced above is "EMA statement on ongoing review of GLP-1 receptor agonists", issued July 11, 2023, and here is its introduction to this latest Ozempic drug safety issue:
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These medicines are used for weight loss and for treating type 2 diabetes.
At the present time, our law firm is reviewing Ozempic drug injury cases involving gallbladder diseases that lead to the need for gallbladder removal surgery. If we can be of assistance to you or someone you know, we encourage you to submit a Case Evaluation Form online. Or, if you prefer, call our toll-free number, (800) 426-9535,
As regards the possible Ozempic side effects of thyroid cancer and suicidal thoughts or self-injury, we will continue to monitor the two ongoing EMA investigations discussed in this article for further findings as regards these Ozempic drug safety issues.
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