The agency says that nearly 400 prescription opioid analgesics, opioid-containing cough products, and benzodiazepine products will be required to have boxed warnings—the agency’s strongest kind—and guides that provide “information about the serious risks associated with using these medications at the same time.”

Outcomes of mixing the medications at the same time “include extreme sleepiness, respiratory depression, coma and death.”

The FDA decided to make this change after data showed that the “number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014.”

The agency also saw that from “2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths…involving both drug classes nearly tripling during that period.”