FDA Investigating Whether Wegovy and Similar Drugs Can Cause Hair Loss, Suicidal Thoughts

Wegovy and similar weight loss drugs may cause more side effects than currently recognized. The Food and Drug Administration is now looking into whether these new generation obesity drugs can trigger hair loss, suicide ideation, and food aspiration, based on adverse event reports linked to their use. These reports are only intended to be a potential warning signal and do not prove causation, but the FDA could take further regulatory action should their investigation bear fruit, such as modifying the drugs’ labeling.

The FDA maintains a public list of potential new safety risks associated with approved drugs, based on reports sent to the FDA Adverse Event Reporting System (FAERS). In an update released Tuesday, covering July to September 2023, the agency is currently flagging a potential link between GLP-1 drugs and suicide ideation, alopecia (hair loss), and aspiration (the risk of food or water going down our airways and lungs, which can cause problems like pneumonia). For each of these potential concerns, the FDA states that it is “evaluating the need for regulatory action.”

Wegovy belongs to a class of drug known as incretins, named after a group of hormones that help regulate our metabolism and hunger. Its active ingredient is semaglutide, a synthetic and longer-lasting version of the hormone GLP-1. In 2017, Novo Nordisk received FDA approval for its Type 2 diabetes drug Ozempic, also made with semaglutide; in 2021, the company won approval for a higher-dose version under the name Wegovy, explicitly intended to treat obesity. In 2022, Eli Lilly won approval for its similar incretin drug, Mounjaro, made with the active ingredient tirzepatide, to treat type 2 diabetes (tirzepatide mimics GLP-1 and another incretin hormone called GIP). And this fall, Eli Lilly received approval for a tirzepatide-based obesity drug sold under the brand name Zepbound.

Whatever you call them, these drugs have dramatically changed the landscape of obesity treatment since their arrival. In clinical trials, they’ve helped people lose substantially more weight than diet and exercise alone. They outperform older obesity drugs, with patients losing from 15% to 25% of their baseline weight over a year’s time. So far, the drugs appear to be generally safe and tolerable, with the most common side effects documented in trials being gastrointestinal symptoms like nausea, vomiting, and constipation, which may wane over time.

But after the approval of these drugs, some patients and doctors have reported more serious complications possibly tied to their use. These complications have included gastroparesis (stomach paralysis), pancreatitis, and ileus (intestinal blockage), among others.

In September 2023, based on these reports, the FDA updated its labeling of Wegovy and Ozempic, warning that the products could potentially cause ileus, though the agency didn’t confirm it as an established risk. Last year, health regulators in Iceland, the UK, and eventually the European Union announced that they would begin to investigate a potential link between suicide ideation and GLP-1 use following case reports. And now the FDA has formally followed suit.

As the FDA is careful to note on its website, adverse event reports shouldn’t be and can’t be used to prove that a drug causes a particular problem, nor can they be used to estimate how common a potential safety risk might be. As an example, some symptoms, like hair loss, have many causes, so a person who loses their hair while taking a GLP-1 drug may have done so whether they were taking the medication or not. Some experts have also noted a lack of evidence tying GLP-1 use to suicide risk in clinical trials, which have collectively involved thousands of people.

At the same time, adverse event data is a valuable source of information, and previously unknown side effects of drugs have been unearthed from these initial reports. So these investigations by the FDA and other health agencies could very well lead to regulatory action. These actions would likely include further changes to the product labeling of these drugs. But it’s not unprecedented for regulators to enact stricter measures, such as black box warnings or even outright pulling a drug from the market. The latter would likely only happen if any newly found side effects clearly offset the known benefits of these drugs, though, which seem to extend beyond weight loss alone.

Wegovy and similar weight loss drugs may cause more side effects than currently recognized. The Food and Drug Administration is now looking into whether these new generation obesity drugs can trigger hair loss, suicide ideation, and food aspiration, based on adverse event reports linked to their use. These reports are only intended to be a potential warning signal and do not prove causation, but the FDA could take further regulatory action should their investigation bear fruit, such as modifying the drugs’ labeling.

The FDA maintains a public list of potential new safety risks associated with approved drugs, based on reports sent to the FDA Adverse Event Reporting System (FAERS). In an update released Tuesday, covering July to September 2023, the agency is currently flagging a potential link between GLP-1 drugs and suicide ideation, alopecia (hair loss), and aspiration (the risk of food or water going down our airways and lungs, which can cause problems like pneumonia). For each of these potential concerns, the FDA states that it is “evaluating the need for regulatory action.”

Wegovy belongs to a class of drug known as incretins, named after a group of hormones that help regulate our metabolism and hunger. Its active ingredient is semaglutide, a synthetic and longer-lasting version of the hormone GLP-1. In 2017, Novo Nordisk received FDA approval for its Type 2 diabetes drug Ozempic, also made with semaglutide; in 2021, the company won approval for a higher-dose version under the name Wegovy, explicitly intended to treat obesity. In 2022, Eli Lilly won approval for its similar incretin drug, Mounjaro, made with the active ingredient tirzepatide, to treat type 2 diabetes (tirzepatide mimics GLP-1 and another incretin hormone called GIP). And this fall, Eli Lilly received approval for a tirzepatide-based obesity drug sold under the brand name Zepbound.

Whatever you call them, these drugs have dramatically changed the landscape of obesity treatment since their arrival. In clinical trials, they’ve helped people lose substantially more weight than diet and exercise alone. They outperform older obesity drugs, with patients losing from 15% to 25% of their baseline weight over a year’s time. So far, the drugs appear to be generally safe and tolerable, with the most common side effects documented in trials being gastrointestinal symptoms like nausea, vomiting, and constipation, which may wane over time.

But after the approval of these drugs, some patients and doctors have reported more serious complications possibly tied to their use. These complications have included gastroparesis (stomach paralysis), pancreatitis, and ileus (intestinal blockage), among others.

In September 2023, based on these reports, the FDA updated its labeling of Wegovy and Ozempic, warning that the products could potentially cause ileus, though the agency didn’t confirm it as an established risk. Last year, health regulators in Iceland, the UK, and eventually the European Union announced that they would begin to investigate a potential link between suicide ideation and GLP-1 use following case reports. And now the FDA has formally followed suit.

As the FDA is careful to note on its website, adverse event reports shouldn’t be and can’t be used to prove that a drug causes a particular problem, nor can they be used to estimate how common a potential safety risk might be. As an example, some symptoms, like hair loss, have many causes, so a person who loses their hair while taking a GLP-1 drug may have done so whether they were taking the medication or not. Some experts have also noted a lack of evidence tying GLP-1 use to suicide risk in clinical trials, which have collectively involved thousands of people.

At the same time, adverse event data is a valuable source of information, and previously unknown side effects of drugs have been unearthed from these initial reports. So these investigations by the FDA and other health agencies could very well lead to regulatory action. These actions would likely include further changes to the product labeling of these drugs. But it’s not unprecedented for regulators to enact stricter measures, such as black box warnings or even outright pulling a drug from the market. The latter would likely only happen if any newly found side effects clearly offset the known benefits of these drugs, though, which seem to extend beyond weight loss alone.