The Food and Drug Administration is investigating possible side effects of GLP-1 drugs, including suicidal thoughts, hair loss, and aspiration. Jaap Arrians/NurPhoto via Getty Images As the GLP-1 drug grows in popularity, researchers continue to investigate its potential side effects. The FDA is investigating reports of side effects from GLP-1 receptor agonists, including suicidal thoughts and hair loss. A large new study has found no link between semaglutide, the active ingredient in GLP-1 drugs such as Ozempic and Wigovy, and suicidal ideation.
GLP-1 drugs such as semaglutide, liraglutide, and tirzepatide are type 2 diabetes drugs that have become popular in the last year for weight loss purposes.
It is estimated that approximately 24 million people, or 7% of the population, will be taking GLP-1 drugs in the United States by 2035.
Wegovy, Saxenda, and Zepbound are GLP-1 drugs currently approved by the FDA as weight loss drugs. Ozempic, Munjaro, etc. may be prescribed off-label for weight loss purposes.
As demand for these drugs increases, researchers and health experts are taking a closer look at the potential side effects of GLP-1 receptor agonists.
The Food and Drug Administration (FDA) investigates reports of adverse events, such as hair loss, suicidal ideation, and aspiration, received by the FDA Adverse Event Reporting System (FAERS).
However, a new study shows that there is no link between semaglutide, the active ingredient in certain GLP-1 drugs such as Ozempic and Wigovy, and suicidal ideation.
Despite the potential for side effects, GLP-1 drugs are considered safe. Medical News Today spoke to three obesity experts to find out more.
The FDA study is not the first time a link between suicidal ideation and GLP-1 medications has been examined.
However, a recent study funded by the National Institutes of Health (NIH) concluded that there is no evidence that GLP-1 drugs, including semaglutide, cause suicidal thoughts.
Researchers examined medical record data from more than 1.8 million patients and found that semaglutide had a lower risk of suicidal ideation than other drugs prescribed for obesity and type 2 diabetes.
Researchers followed patients for six months after they were prescribed the drug and found that patients who took semaglutide for weight loss had a 0.1% risk of first-time suicidal thoughts. In subjects with a history of self-harm, the risk of recurrent suicidal ideation increased to 7%.
However, not all GLP-1 drugs, such as Mounjaro and Zepound, contain semaglutide. This means that, especially in patients with a history of mental health conditions, suicidal thoughts may occur as a side effect and may require further evaluation.
As a precautionary measure, Dr. Seth Kipnis, medical director of bariatric and robotic surgery at Jersey Shore University Medical Center, Hackensack Meridian Medical Group in New Jersey, told MNT that patients should not be prescribed GLP before being prescribed GLP. He said he may want to be screened for mental illness. -1 medicine.
The FDA is also investigating hair loss, medically known as alopecia, as a side effect of GLP-1 drugs.
Mir Ali, M.D., a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, Calif., says even after hearing that hair loss may be a side effect of GLP-1 drugs, He told MNT that he was not surprised.
“I’m not surprised because patients experience hair loss no matter how much weight they lose, whether it’s due to medication, dieting on their own, or surgery,” Dr. Ali explains. did. “It typically occurs in women and is caused by hormonal changes associated with weight loss, and is not necessarily due to the direct effects of medications.”
Dr. Lydia C. Alexander, chief medical officer at Enara Health and president-elect of the Obesity Medicine Association, agreed, saying that the most common causes of hair loss during obesity treatment are rapid weight loss and low levels of trace minerals and vitamins. He said that it is a lack of.
“In some studies, up to 57% of patients undergoing surgery for metabolic bariatric surgery experienced hair loss, which typically starts at three months and lasts up to a year,” Dr. Alexander continued.
“The most common vitamin and mineral deficiencies seen in patients with hair loss following bariatric surgery or weight loss are zinc, iron, folic acid, and vitamin B12. Protein deficiencies can also contribute to hair thinning. Excessive intake of vitamin A has also been reported to increase hair loss.
“GLP-1 drugs cause more rapid weight loss, similar to restrictive very low-calorie diets, so it is not surprising to hear of case reports and increased incidence of hair loss. Our experience Hair will regrow in 3-6 months after weight stabilization with supplementation and dietary monitoring/nutritional counseling.
— Dr. Lydia C. Alexander, Obesity Expert
Aspiration occurs when a liquid, food, or other object accidentally enters a person’s airway and reaches the lungs. This occurs when a person swallows something (colloquially known as a “misdirection”) or when food or liquid comes regurgitating from the stomach.
Dr. Ali said that aspiration as a side effect of GLP-1 drugs makes sense because one of the effects of these drugs is to slow stomach emptying.
“Some of the more sensitive patients may have a full stomach for a longer period of time, instead of emptying as normal,” he explained. “Therefore, if you go to bed with a full stomach, some of the contents may spill out and be aspirated.”
“Patients scheduled for surgery are cautioned to stop these medications at least a week before surgery to give the stomach a chance to return to normal,” added Dr. Ali. “It’s important not to eat too soon before bed. Especially if you’re planning to have surgery, you’ll need to continue taking your medication before surgery.”
“Overeating and ignoring the effects of medicines can lead to nausea, vomiting, and even aspiration,” Dr. Kipnis added. “For these drugs to be effective, people need to follow proper diet and portion size guidelines.”
MNT told an FDA spokesperson what prompted the agency to investigate potential side effects of GLP-1 drugs and what specific recommendations or further research into causal relationships may merit labeling changes. I asked him if he had any plans.
A spokesperson told MNT that the FDA monitors safety throughout a drug’s lifecycle, including after approval.
“Additionally, the FDA maintains a system of postmarket surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process. If new safety indicators are identified. “The FDA will determine what action is appropriate after a thorough review of the available data,” an FDA spokesperson said.
Dr. Alexander said the FDA’s current assessment of these potential side effects is to aggregate drug-related side effects, report them, and further investigate them to identify previously unseen or unidentified drug-related side effects. He said this is the right way to understand if there are any additional mild to severe side effects. Important during clinical trials.
“Assess all medicines for potential signs of serious risk and, where significant signs are found, update prescribers and the public with new safety information on identified medicines.” It’s the FDA’s job to make it public,” Dr. Alexander said.
When asked what needs to be done to establish a direct link between taking GLP-1 drugs and side effects such as hair loss, suicidal thoughts, and aspiration, Dr. Kipnis said, He said more research is needed to find out what happens when people stop using drugs.
“In the short term, these drugs produce significant weight loss with minimal side effects, but what are the long-term side effects?” Dr. Kipnis asked. “How long can a person continue to take these drugs? “Obesity is a long-term problem. Are these drugs just a short-term solution?”
For those who may be taking or considering GLP-1 receptor agonists, it is helpful to have a doctor who will continue to monitor you and keep you up-to-date on any side effects you may experience. All experts agree that getting medical attention is important.
“It’s important to thoroughly discuss side effects with your health care provider,” says Dr. Alexander.
“Physicians board-certified in obesity medicine and advanced practitioners with NP/PA certification in obesity medicine discuss the risks and benefits of GLP-1 drugs and discuss potentially serious We are well-equipped to monitor and identify side effects of these drugs.”
“These new drugs require an in-person examination by a doctor, including a physical exam and weight measurements, before being prescribed,” Dr. Kipnis said.
“Patients should also see a registered dietitian while taking these medications. Regular follow-up by the prescribing physician is required to avoid complications and monitor patient compliance.” .”
“Patients taking these drugs must meet current FDA guidelines. Many of these are not done nationally. These drugs are recommended for cosmetic reasons in non-obese patients. They are often used, prescribed exclusively through telemedicine, or by health care providers who have no previous experience managing obesity and are not qualified to prescribe.”
— Dr. Seth Kipnis, Bariatric Surgeon
