The Food and Drug Administration (FDA) has addressed concerns regarding a potential side effect of a new class of obesity drugs developed by Eli Lilly and Novo Nordisk. The agency's comprehensive review found no evidence linking the use of GLP-1 receptor agonists to suicidal thoughts or actions, although the investigation is ongoing.
In response to European Union health regulators reviewing data on the risk of suicidal thoughts associated with certain GLP-1 receptor agonists, concerns have been raised since last summer. GLP-1 receptor agonists include Eli Lilly's Zepbound, a weight loss drug, and Mounjaro, a Type 2 diabetes treatment, as well as Novo Nordisk's Wegovy, another weight-loss drug, and Ozempic, a Type 2 diabetes drug.
Due to the potential risk of suicidal thoughts in patients using weight loss pills, regulatory bodies and healthcare professionals closely monitor this aspect. A decade ago, an obesity drug called rimonabant was approved in Europe but later withdrawn from the market due to studies linking it to severe side effects, including suicide.
Now, the FDA includes warnings on the labels of all obesity drugs, including Zepbound and Wegovy, instructing healthcare providers to monitor patients for suicidal thoughts or behaviors.
In its recent statement, the FDA revealed that it has been assessing reports of suicidal thoughts or actions among patients using GLP-1 receptor agonists and has found no association between these drugs and suicidal thoughts. Both adverse event reports received through the FDA system and new scientific studies supported this finding.
However, the FDA emphasized that its investigation is ongoing. Due to the low number of observed suicidal thoughts or actions in both individuals using GLP-1 receptor agonists and the comparative control groups, the agency cannot definitively rule out the existence of a small risk. Consequently, the FDA continues to investigate this matter further.
Novo Nordisk and the FDA
Novo Nordisk, a pharmaceutical company, has acknowledged that the FDA is currently examining several potential signals related to GLP-1 receptor agonists. Novo Nordisk expresses its readiness to collaborate with the FDA during the review process. They firmly stand behind the safety and effectiveness of their GLP-1RA medicines when used as directed and under the supervision of a licensed healthcare professional.
Lilly, another pharmaceutical company, has not yet responded to the FDA's statement. As of Thursday afternoon, Lilly shares have risen by 0.9%, while Novo's American depositary receipt has declined by 1.5%.
Recent evidence suggests that concerns regarding a connection between these drugs and suicidal thoughts are likely unfounded. In fact, a retrospective study published in the scientific journal Nature Medicine, which analyzed over a million health records, found no increased risk of suicidal ideation in patients using semaglutide (sold as Wegovy and Ozempic).
In early December, a risk assessment committee at the European drug regulatory agency conducted an investigation and concluded that no definitive causal association could be established. However, they acknowledged the need for further clarification on certain issues.
While the FDA's investigation is ongoing, this announcement appears to reduce the possibility of concerns surrounding suicidal ideation negatively impacting the use of GLP-1 drugs.
The rising popularity of these medicines, coupled with the immense market potential they offer, has significantly boosted Lilly shares by over 140% in the past two years. This success has had far-reaching effects on valuations across various industries, including medical devices and snack food.
Additionally, the FDA is currently evaluating reports of potential risks of alopecia and aspiration in patients using GLP-1 receptor agonists, indicating that regulatory action may be necessary.