January 4, 2023 – The FDA is officially investigating reports that some individuals who took popular diabetes and weight reduction medications had suicidal thoughts or two other health problems.
A brand new FDA report lists possible links between the drugs and a hair loss condition called alopecia, a swallowing problem that may occur during surgery called aspiration, or suicidal thoughts, CBS News reported. The investigation focuses on reports of health problems in people popping up often known as GLP-1 receptor agonists, including Ozempic, Wegovy, Mounjaro and Zepbound. The drugs are used to treat diabetes and obese or obesity.
The FDA's investigation of those reports doesn’t mean that the federal agency has concluded that a risk exists, however the FDA has website for risk assessment precautions.
“This means that the FDA has identified a potential safety issue, but it does not mean that the FDA has determined a causal relationship between the drug and the listed risk,” the FDA website says.
Possible next steps after an investigation could include updating drug labels with recent information, implementing a risk management plan to forestall or manage the health risks, or gathering more information.
“The FDA monitors the safety of drugs throughout their life cycle,” including after the drugs are approved. In addition, the FDA uses “surveillance and risk assessment programs to identify and evaluate adverse events that did not occur during the drug development process,” FDA spokesman Chanapa Tantibanchachai said in an email published by multiple news outlets.
While an investigation may not end in changes to the way in which a drug is regulated by the FDA, this isn't the primary time the favored drugs have landed on the FDA's radar for re-evaluation of their safety. Last yr, the drug Ozempic's label was updated to deal with reports of intestinal obstruction, CBS News reported.
European regulators are also looking into this Reports Suicidal thoughts in people taking GLP-1 receptor agonists, although no link has been proven.
Concerns about aspiration during surgery led the American Society of Anesthesiologists to advise in June that folks stop taking GLP-1 receptor agonists before undergoing elective surgery.
“Although there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients undergoing surgery and interacting with anesthesia, we have received anecdotal reports that delay in gastric emptying is associated with an increased risk of Regurgitation and aspiration may be associated “During general anesthesia and deep sedation, food enters the airways and lungs,” said the society's president, Dr. Michael W. Champeau, in a statement opinion by the time.
According to CBS News, the FDA's drug reporting system links the drugs to 201 reports of suicide or suicidal ideation, 18 reports mentioning aspiration and 422 reports mentioning alopecia.
This was announced by the drug manufacturer Novo Nordisk, whose portfolio includes Wegovy and Ozempic CNN that it is working with the FDA to monitor safety and is aware of reports of side effects.
“Novo Nordisk stands behind the safety and effectiveness of all of our GLP-1RA medications when used as directed and taken under the supervision of a licensed healthcare professional,” the company said in a statement to CNN.
A spokesperson for Eli Lilly, maker of Mounjaro and Zepbound, told CBS News in a statement: “Currently, the FDA is reviewing data regarding certain potential risks for GLP-1 receptor agonist drugs. Patient safety is our priority and we are working with the FDA on these potential signals.”