FDA Safety Changes: Pexeva, Vfend, Suprane

The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for serotonin syndrome in patients receiving concomitant treatment with paroxetine mesylate and triptans, drug interactions between voriconazole and efavirenz requiring dose adjustments for both drugs when used concomitantly, and the risk for respiratory adverse events associated with use of desflurane in certain pediatric settings.
Concomitant Use of Paroxetine Mesylate (Pexeva) and Triptans Linked to Risk for Serotonin Syndrome On December 9, 2006, the FDA approved safety labeling revisions for paroxetine mesylate (Pexeva tablets, made by Synthon Pharmaceuticals, Ltd) to advise of the potential increased risk for serotonin syndrome in patients receiving concomitant treatment with other serotonergic drugs (including 5-hydroxytryptamine-receptor agonists [triptans]) or drugs that impair serotonin metabolism (including monoamine oxidase inhibitors [MAOIs]).

Concurrent treatment with paroxetine and MAOIs is therefore contraindicated. Concomitant use of other selective serotonin reuptake inhibitors (SSRIs), serotonin/norepinephrine reuptake inhibitors (SNRIs), or the serotonin precursor tryptophan is not recommended. Caution is advised when using paroxetine in combination with other drugs or agents that can affect serotonergic neurotransmitter systems, such as the antibiotic linezolid (a reversible nonselective MAOI), lithium, tramadol, St. John's Wort, and triptans.

According to the FDA, rare postmarketing cases of serotonin syndrome have been reported with use of SSRIs and triptans. Associated symptoms may include changes in mental status (eg, agitation, hallucinations, and coma), autonomic instability (eg, tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (eg, hyperreflexia and incoordination), and/or gastrointestinal tract symptoms, such as nausea, vomiting, and diarrhea.

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