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FDA Safety Changes: Cymbalta

 

Concomitant Use of Duloxetine HCl (Cymbalta) With Triptans Linked to Risk for Serotonin Syndrome On September 20, 2006, the FDA approved safety labeling revisions for duloxetine HCl delayed-release capsules (Cymbalta, made by Eli Lilly and Co, Inc) 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]). Duloxetine is classified as a serotonin/norepinephrine reuptake inhibitor (SNRI).

Potential symptoms of serotonin syndrome 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.

Concomitant use of duloxetine with MAOIs for the treatment of depression is therefore contraindicated, and use of serotonin precursors (eg, tryptophan) is not recommended.

Caution is advised when using duloxetine 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. Patients for whom concurrent use of an SNRI and a triptan is clinically warranted should be carefully monitored, particularly during treatment initiation and dose increases.

Triptans are a class of drug used to treat migraines and include naratriptan HCl (Amerge, made by GlaxoSmithKline), almotriptan malate (Axert, made by Ortho-McNeil Pharmaceutical, Inc), frovatriptan succinate (Frova, made by Endo Pharmaceuticals), sumatriptan/sumatriptan succinate (Imitrex, made by GlaxoSmithKline), rizatriptan benzoate (Maxalt and Maxalt-MLT, made by Merck and Co, Inc), eletriptan HBr (Relpax, made by Pfizer, Inc), and zolmitriptan (Zomig and Zomig ZMT, made by AstraZeneca Pharmaceuticals LP).

Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder and the management of pain associated with diabetic peripheral neuropathy.

Posted 10-24-07