STORY FROM: Drugs & Medical Devices
FDA Mandates Addition of New Warnings to Labels of Opioid Pain Drugs
March 22, 2016
WASHINGTON, D.C. — The Food and Drug Administration has ordered the makers of opioid pain drugs to add warnings to their labels regarding the risks of potentially harmful interactions with other medications, problems with the adrenal glands, and decreased sex hormone levels.
According to the agency’s March 22 Safety Communication, “opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity.” In addition, “taking opiods may lead to a rare, but serious condition in which the ...