Wegovy and similar weight-loss drugs may cause more side effects than currently recognized. The U.S. Food and Drug Administration is currently studying whether these next-generation obesity drugs may trigger hair loss, suicidal ideation and food cravings based on reports of adverse events associated with their use. These reports are a potential red flag and do not prove causation, but if the investigation yields results, the FDA may take further regulatory action, such as changing drug labeling.
FDA maintains a public list of potential new safety risks associated with approved drugs based on reports sent to the FDA Adverse Event Notification System (FAERS).In update freed 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 going down our airways and lungs, which can cause problems like pneumonia). For each potential concern, the FDA said it is “evaluating the need for regulatory action.”
Wegovy belongs to a class of drugs called incretins, named after a group of hormones that help regulate metabolism and hunger. Its active ingredient is semaglutide, a synthetic and longer-lasting version of the GLP-1 hormone. In 2017, Novo Nordisk’s type 2 diabetes drug Ozempic, also made from semaglutide, was approved by the FDA; in 2021, the company’s high-dose version of Wegovy was approved, expressly for the treatment of obesity. In 2022, Eli Lilly won approval for its incretin-like drug Mounjaro, made from the active ingredient tezepatide, to treat type 2 diabetes (tezepati mimics GLP-1 and another drug called GIP of incretin hormones). This fall, Eli Lilly won approval for its tilsiparatide-based obesity drug, branded Zepbound.
No matter what you call them, these drugs have a huge change occured The future of obesity treatment since their arrival. In clinical trials, they help people lose far more weight than diet and exercise alone. They work better than older weight-loss drugs, with patients losing 15 to 25 percent of their baseline weight within a year. So far, the drugs appear to be generally safe and tolerable, with the most common side effects documented in trials being gastrointestinal symptoms such as nausea, vomiting and constipation, which may diminish over time.
But after these drugs were approved, some patients and doctors reported More serious complications Probably related to their purpose. These complications include gastroparesis (paralysis of the stomach), pancreatitis, and ileus (intestinal obstruction), among others.
In September 2023, based on these reports, the FDA renew Its labels for Wegovy and Ozempic warn that these products may cause intestinal obstruction, but the agency has not confirmed the risk.Last year, health regulators in Iceland, the United Kingdom and the European Union declare They will begin investigating potential links between suicidal ideation and GLP-1 use based on case reports. Now the FDA has officially followed suit.
As the FDA is careful to point out on its website, adverse event reports should not and cannot be used to prove that a drug causes a specific problem, nor to estimate the prevalence of potential safety risks. For example, some symptoms, such as hair loss, have multiple causes, so people who lose hair while taking GLP-1 medications may experience hair loss regardless of whether they take the medication.Some experts also pointed out lack of evidence GLP-1 use has been linked to suicide risk in clinical trials involving thousands of people in total.
At the same time, adverse event data are a valuable source of information, and previously unknown drug side effects can be unearthed from these preliminary reports. Therefore, these investigations by the FDA and other health agencies will likely result in regulatory action. These actions may include further changes to product labeling for these drugs. But it’s not unprecedented for regulators to take more stringent measures, such as black box warnings or even simply removing a drug from the market.The latter may only occur if the newly discovered side effects significantly offset the known benefits of these drugs, however, this appears to be beyond Lose weight alone.
