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FDA warns methylene blue, linezolid may cause serotonin syndrome when co-administered with certain psychiatric medications
Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.
Key Points
Two Drug Safety Communications providing updated warnings regarding potentially serious interactions (some fatal) when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications [selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant, monoamine oxidase inhibitor (MAOI), or other psychiatric medication with serotonergic effects], were released by FDA on October 20, 2011.
Methylene blue is commonly used to help visualization in diagnostic procedures and to treat methemoglobinemia, vasoplegic syndrome, ifosfamide-induced encephalopathy, and cyanide poisoning. Linezolid is an antibiotic used to treat infections caused by a resistant bacterium. Both agents have MAOI properties, which mean they can inhibit the action of an enzyme responsible for breaking down serotonin in the brain. Overly elevated serotonin levels can result in serotonin syndrome, symptoms of which include mental status changes, muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.
FDA is releasing these updated warnings after a detailed review of adverse reports from the AERS database and the published medical literature. Upon review of cases, FDA noted the above-mentioned adverse events typically occurred when patients were receiving intravenous methylene blue during parathyroid surgery at doses between 1 mg/kg and 8 mg/kg. Moreover, a majority of the methylene blue cases occurred with concomitant SSRI, SNRI, or clomipramine administration. Not dissimilarly, linezolid cases were also associated with SSRI or SNRI co-administration, and of note, occurred even after the discontinuation of serotonergic psychiatric medications with long half-lives. FDA is therefore recommending these agents generally not be given to patients taking serotonergic drugs unless they are being used to treat urgent or life-threatening conditions.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
