Ozempic Suicide Risks Result in Investigation by European Medicines Agency
European drug regulators have opened an investigation into potential Ozempic suicide risks, following reports of patients in Iceland experiencing suicidal ideations after taking the diabetes drug, as well as a similar weight loss medication known as Saxenda.
According to a Reuter’s report, the European Medicines Agency has now launched a safety probe into the two Novo Nordisk drugs, which both use the same active ingredient. The investigation comes as Ozempic’s popularity has been on the rise in the United States, especially for off-label use as a weight loss medication.
Ozempic (semaglutide) was originally approved for the treatment of people with Type 2 diabetes. However, in recent months Ozempic has been increasingly prescribed for weight loss. Saxenda is already approved for weight loss treatment.
The EMA investigation comes after the Icelandic Medicines Agency reported two incidents where Ozempic patients reported having suicidal thoughts. A third patient reported similar thoughts of self-injury after using Saxenda, Icelandic regulators reported.
Novo Nordisk claims there are no known causal connections between Ozempic and suicide, and the two drugs do not carry label warnings in the EU alerting patients to potential suicidal thoughts risks. However, the drug Wegovy, which is also a weight loss medication sold in the U.S. using semaglutide, does carry such a warning, calling for patients taking the drug to be monitored for suicidal thoughts and behaviors.
In the U.S., semaglutide-based drugs have been linked to at least 60 reports of suicide ideation since 2018, the Reuters report indicates.
Suicide risks and ideations have long been linked to weight loss drugs, such as Contrave and Qsymia, making it difficult for them to gain approved in the U.S.
Ozempic Thyroid Cancer Concerns
This is the second investigation into this class of diabetes and weight loss drugs launched by European regulators in recent weeks. In May, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) issued warnings that Ozempic, Wegovy and other glucagon like peptide-1 receptor agonists (GLP-1) may carry an increased risk of thyroid cancer.
The active ingredient in the two drugs, semaglutide, was specifically called out by European regulators as being tied to thyroid cancer signals. However, the data does not establish a causal link.
Sales of the two drugs are estimated to reach combined sales of $15.3 billion this year alone.
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In its recommendations, PRAC called for manufacturers of GLP-1 drugs, including Novo Nordisk, Eli Lilly and others, to provide the committee with supplementary information on the drugs by July 26, and is calling for regulatory action from the EMA to address the risks. In addition, the committee is calling for updates to the safety labels of those drugs in the European Union.
Eli Lilly has previously acknowledged there appears to be a link between the class and thyroid cancer side effects, and is in the process of conducting a pair of studies to more thoroughly explore the potential link.
Ozempic Hair Loss Concerns
The investigation also comes amid increasing reports that Ozempic side effects have been linked to hair loss when using the diabetes drug as a weight loss treatment.
Some doctors have claimed hair loss after Ozempic use is a natural result of rapid weight loss. This effect is known as telogen effluvium. However, Ozempic may also cause hormonal shifts which can also trigger early onset pattern hair loss in men and women, known as androgenic alopecia, which is progressive and continues to worsen over time. This can lead to permanent hair loss, some health experts warn.
In March, the founder of The American Hair Loss Association (AHLA) and The International Alliance of Hair Restoration Surgeons, warned against misuse of Ozempic for weight loss in an editorial in Dermatology Times, indicating that the hair loss experts do not recommend the off-label use of the diabetes drug.
August 2023 Ozempic Lawsuit Update
The first of what could be thousands of Ozempic lawsuits to come was filed by a Louisiana woman on August 2, 2023, claiming she experienced severe gastroparesis and stomach problems after using Ozempic for more than a year before switching to the similar diabetes drug Mounjaro.
The lawsuit claims both Novo Nordisk, the manufacturer of Ozempic, and Eli Lilly, the manufacturer of Mounjaro, both knew, or should have known, that the drugs increase the risk of gastroparesis and gastroenteritis that can lead to severe side effects such as nausea, vomiting undigested food, abdominal pain, abdominal bloating, severe dehydration, feeling full after only a few bites, undigested food hardening in the stomach, acid reflux, fluctuating blood sugar levels, lack of appetite, weight loss, malnutrition and decreased quality of life.
The lawsuit notes that despite a number of case studies and clinical reports warning that the drugs could cause, or exacerbate, gastroparesis in particular, neither manufacturer has updated the label warnings.
Similar problems stated in the lawsuit were outlined in a CNN report published on July 25, detailing several incidents of stomach paralysis, also known as gastroparesis, as well as previous research that has linked these types of diabetes drugs to similar risks in the past.
As a result of the growing number of Ozempic side effects reported, it is expected that thousands of individuals who have suffered similar injuries will begin filing claims raising similar allegations that the manufacturers failed to adequately research and warn the medical community about potential side effects.
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