"You know, that's not necessarily what goes on in clinical practice," she says. They would have been excluded from participating. Amy Rothberg, an endocrinologist at the University of Michigan, says patients recruited for the Ozempic clinical trials were screened for depression, anxiety and suicidal thoughts. There's another limitation to the preapproval studies: Who gets to be part of them. Previous clinical studies offer few answers Once a drug is on the market, millions of patients might take it for years. She explained that these kinds of incidents often don't happen during the drug's clinical trials because those studies include relatively small numbers of patients who are taking the drug for a limited time. "FAERS data are particularly useful for identifying new (i.e., unexpected or unlabeled), rare, serious adverse events that are temporally associated with a product for which the background rate of events is low," she wrote in an email to NPR. FDA uses what it finds in FAERS to do more research and, in some cases, make changes to the instructions for doctors and patients. And this database is actually not able to do that."ĭespite its weaknesses, the FAERS database is still a critical tool for the FDA, says the agency's Tantibanchachai. "So we need to carefully account for that. "It could also be the case that the underlying indication, for example, which is obesity, is also known to have a higher risk for mental health issues," he says. As a result, it has no denominator or comparison group to tease out whether adverse events – like suicidal thoughts – are the result of a drug or something else. The FDA database is voluntary, unverified by the agency and may have duplicates. "It's a passive surveillance system where people like you and me – patients, caregivers, medical providers – can report a safety event if they feel that that patient has suffered an adverse outcome from a drug that they had been on," says Rishi Desai, an assistant professor at Harvard Medical School who studies drug side effects. The FDA database can flag questions but isn't designed to answer them. It isn't known if Ozempic and the other drugs caused the mental health problems. In 96 of those reports, the patient had suicidal thoughts. NPR analyzed the FDA's adverse event reporting system, or FAERS, and learned that the agency has received 489 reports of patients experiencing anxiety, depression or suicidal thoughts while taking semaglutide drugs, including Ozempic, Wegovy and Rybelsus. 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. "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. For now, the agency is monitoring the situation. As of July 11, the regulator, Europe's FDA, was evaluating more than 150 reports. 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. Are the problems a coincidence or related to the drug? European regulators investigate mental health reports But that side effect isn't mentioned in Ozempic's instructions for use, or drug label. She's one of many people taking Ozempic and related drugs who describe mental health problems. I still didn't put it together, so I kept. "So my response to that was just I was just crying all the time. "I was just constantly in a state of being overwhelmed," says Kent.
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