FDA Safety Notices on Drug-Drug Interactions Involving Methylene Blue or Linezolid and Certain Psychiatric Medications

FDA has issued two safety communications regarding adverse drug reactions in patients taking certain psychiatric medications, and also given methylene blue or linezolid (Zyvox®). Specifically, FDA has received reports of serious central nervous system reactions in patients taking serotonergic psychiatric medications who are also given methylene blue, a product commonly used in diagnostic procedures. FDA explains that “[a]lthough the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A – an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.” FDA has published a list of the serotonergic psychiatric medications that can interact with methylene blue and advises that “Methylene blue should generally not be given to patients taking serotonergic drugs.” Exceptions and more information for health care providers and patients are available in an FDA Drug Safety Communication.

Similar reports of interactions between certain serotonergic psychiatric medications and the antibacterial drug, linezolid (Zyvox) have also been reported to FDA. FDA has published a list of the serotonergic psychiatric medications that can interact with linezolid and advises that “Linezolid should generally not be given to patients taking serotonergic drugs.” Exceptions and more information about the linezolid interaction for health care providers and for patients are available in an FDA Drug Safety Communication.