Label Changes for:

Zomig (zolmitriptan) tablets and orally disintegrating tablets

August 2010

Changes have been made to the PRECAUTIONS sections of the safety label.

  • Amerge (naratriptan) 1 and 2.5 mg tablets
  • Maxalt (rizatriptan benzoate) Rapidisk tablets
  • Maxalt (rizatriptan benzoate) tablets
  • Zomig (zolmitriptan) Orally Disintegrating tablets
  • Zomig (zolmitriptan) 2.5 and 5 mg tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010

PRECAUTIONS

  • Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome: Cases of life-threatening serotonin syndrome have been reported during combined use of SSRIs or SNRIs and triptans
  • Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of triptans and SSRIs or SNRIs.
Patient Information
  • Some people may have a reaction called serotonin syndrome when they use certain types of antidepressants, SSRIs or SNRIs, while takingtriptan. Symptoms may include confusion, hallucinations, fast heart beat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking triptan.
Hide
(web5)