The 2017 lawsuit stated that Akorn Pharmaceuticals failed to note in its prescription warning labeling that its drug methylene blue would react adversely with antidepressant Effexor UR, which the woman was already taking when she was given methylene blue during a surgery. The adverse drug interaction caused her to go into a coma and suffer permanent brain damage.
FDA Drug Labeling Requirements
In 2006, the Federal Drug Administration (FDA) issued a prescription drug product labeling guidance for industry Drug makers, requiring them to list any adverse reactions that occur with a drug and with drugs in the same pharmacologically active and chemically related class. This is to ensure that information about adverse reactions are readily accessible for health care practitioners, to make correct prescribing decisions.
Drug makers and distributors are required to submit documentation about their products to the FDA. Product documentation must contain a summary of essential scientific information needed for the safe and effective use of the drug. The FDA then returns data from drug maker submissions to use for product labeling, including when to use the product and adverse reactions to it when used alone or with drugs in the same pharmacologically active and chemically related class.
Reported Adverse Events Trigger Methylene Blue Warning
Following adverse event reports from the FDA Adverse Event Reporting System (AERS) of serious central nervous system (CNS) reactions in patients administered methylene blue who were also taking serotonergic psychiatric medications, in 2011 the Federal Drug Administration (FDA) warned that “methylene blue should generally not be given to patients taking serotonergic drugs (antidepressants).” Reported adverse events were lethargy, confusion, delirium, agitation, aggression, and coma. They were frequently accompanied by the following neurological symptoms: muscle spasms, loss of ability to communicate, seizures, fever, and high blood pressure.
The FDA reports indicated that methylene blue could adversely react with serotonin-norepinephrine reuptake inhibitors (SNRIs) and other monoamine oxidase inhibitors (MAOIs) and psychiatric drugs, including Paxil, Zoloft, Prozac, Lexapro, Cymbalta, Celexa, Effexor, Wellbutrin, and Zyban.
Methylene Blue with Antidepressants Causes Serotonin Syndrome
Methylene blue inhibits the action of monoamine oxidase-A, an enzyme that breaks down serotonin, a naturally-occurring chemical in the brain that acts as an antidepressant. The FDA concluded that methylene blue administered along with antidepressants causes high levels of serotonin to build up in the brain, creating what is known as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, and memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.
In its warning, the FDA said that serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment, and Prozac, which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance.
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