FDA Calls For Removal of Suicide Warnings
By Rebeca Funes
Originally, GLP-1 agonist drugs contained warnings of suicide ideation and behavior but as of recent the U.S. Food and Drug Administration (FDA) has removed these warnings. The FDA is a U.S. Federal agency within the Department of Health and Human Services that protects the public health by ensuring the safety and effectiveness of human and animal drugs, vaccines, food, etc.
GLP-1 receptor agonist (RAs) drugs are a class of injectable medicines, such as Ozempic, that mimic the natural hormone GLP-1 that helps regulate blood sugar by stimulating insulin release and slowing digestion. They were originally used to treat diabetes, but some use them for cosmetic purposes.
These warnings were put into place for various factors like post-marketing reports, the relationship between obesity and depression, and the precedent with other weight-loss drugs. The FDA received reports of suicidal ideation and behaviors from patients taking GLP-1 drugs and enacted the warning requirement.
Furthermore, obesity and depression have a bidirectional relationship, meaning that they influence each other reciprocally. This makes it so it’s difficult to differentiate drug effects from underlying conditions. This risk is extremely important to monitor and manage to prevent drug safety crises, as seen in past experiences with Rimonabant, an anti-obesity drug.
Medicines such as Rimonabant reduced appetite and improved metabolic risk factors such as cholesterol, but were withdrawn from the market as it caused major psychiatric side effects. This included depression, anxiety, and suicide ideation.
“Although I don’t see anything wrong with taking GLP-1 drugs, I feel no need to take them, even without any side effects. However, if these drugs had such consequences, I probably would be against taking them and would no longer be neutral regarding them,” Katherine Melendez, a senior at Barbara Goleman.
Through these past experiences and post-marketing reports, it was clear that GLP-1 drugs needed to be monitored. These warnings hold significant weight and can influence whether a person would want to take these medications. This makes it extremely important to ensure the warnings imposed are factual, prompting the FDA to conduct further research.
“If I were taking GLP-1 drugs and there were those types of warnings on them, I would consider whether the pros outweigh the cons. If I was on the drug for a serious condition like diabetes, I would stay on them, albeit close monitoring. However, if it was not essential for me to continue these drugs, I’d rather switch to a safer alternative,” said Ella Hermannsson, a sophomore at Barbara Goleman.
Through the FDA’s investigation, it was found that GLP-1 drugs do not show a causal link to suicidal thoughts or actions. They were able to find this through a meta-analysis, meaning a composite of multiple studies with the same topic and clinical trials.
According to Reuters who did a preliminary review, there were 91 placebo-controlled clinical studies that were reviewed by the FDA. This involved 107,910 patients, with 60,338 who received the GLP-1 drug and 47,572 who received a placebo. It is important to note that the GLP-1 drugs affected are specifically Semaglutide (Wegovy), Tirzepatide (Zepbound), and Liraglutide (Saxenda).
However, due to the small number of suicidal thoughts or actions observed in people using GLP-1 agonist drugs, they cannot conclude that there is not at least a small risk involved. The FDA is continuing its efforts to thoroughly investigate any risks involved with these drugs.
The FDA urges patients taking GLP-1 drugs to not stop taking their medications without consulting their health care professionals and for professionals to monitor and advise their patients to report any worsening conditions of depression, suicidal thoughts, and any changes in their mood or behaviors. As of now, the FDA states that GLP-1 RAs do not show any causation of suicidal ideation or behavior.
