A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Methylene Blue: Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications. According to the Food & Drug Administration FDA’s MedWatch:
FDA has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications). A list of the serotonergic psychiatric medications that can interact with methylene blue can be found in the Drug Safety Communication. Safety information about this potential drug interaction and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications.****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 include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.****Methylene blue should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with methylene blue such as when it is used in the emergency treatment of methemoglobinemia, ifosfamide-induced encephalopathy, or cyanide poisoning. Patients should not stop taking their serotonergic psychiatric medicine without first talking to a healthcare professional.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Methylene Blue: Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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