Nearly three months into taking Ozempic for diabetes, Jenny Kent had already lost 12 pounds, and her blood sugar numbers were looking better than they had in a while.
Ozempic, the injectable drug approved for Type 2 diabetes, has taken the world by storm.
But for Kent something else changed after she started taking Ozempic.
"I was just constantly in a state of being overwhelmed," says Kent. "So my response to that was just I was just crying all the time. Sobbing, crying ... I still didn't put it together, so I kept ... taking my injections."
She's one of many people taking Ozempic and related drugs who describe mental health problems. But that side effect isn't mentioned in Ozempic's instructions for use, or drug label.
In July, the European Medicines Agency said that it was looking into the risk of thoughts of self-harm and suicidal thoughts with the use of Ozempic and similar drugs. As of July 11, the regulator, Europe's FDA, was evaluating more than 150 reports.
The FDA hasn't taken that step. For now, the agency is monitoring the situation. "We continue to conclude that the benefits of these medications outweigh their risks when they are used according to the FDA approved labeling," spokesperson Chanapa Tantibanchachai said in an email to NPR. She noted that weight-loss drug Wegovy, which contains the same active ingredient as Ozempic, semaglutide, includes a warning about suicidal thoughts on its label.
Even though the link between these drugs and mental health concerns isn't definitive, it's important that patients talk with doctors if they experience something unusual, says Dr. Jonathan Alpert, who chairs the Department of Psychiatry and Behavioral Sciences at Montefiore Medical Center and Albert Einstein College of Medicine.
"I always think it makes sense to take side effects like that seriously, particularly in drugs that are relatively new and that we're still learning about," he says.
I believe Wegovy is a higher dose than Ozempic, it's possible that the high dose can cause psychological concerns in a subset of people, and some smaller subset have issues even with the smaller dose. If the smaller subset is sufficiently smaller such that it doesn't warrant a warning, maybe it's correct that the warning is on one and not the other.
150 reports is likely not the entire amount of impact, but it's also a miniscule number compared to the 60,000 new prescriptions per week in the USA. There has to be a bar where an impact is not worth noting.