Label Changes for:

Zomig (zolmitriptan) Nasal Spray

October 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Peripheral Vascular Disease (added)

WARNINGS AND PRECAUTIONS

  • Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events
    • Cardiac Events and Fatalities with 5-HT1 Agonists
  • Cerebrovascular Events
  • Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia
  • Serotonin Syndrome

ADVERSE REACTIONS

  • Postmarketing Experience with Zomig Tablets
    • Digestive
      • Splenic infarction (added)
    • General
      • Serotonin syndrome (added)

DRUG INTERACTIONS

  • Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

USE IN SPECIFIC POPULATIONS

  • Pegnancy
  • Pediatric Use
  • Hepatic Impairment

NONCLINICAL TOXICOLOGY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • Carcinogenesis
    • Mutagenesis

PATIENT COUNSELING INFORMATION (new)

  • Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-related Event, and Cerebrovascular Events
  • Serotonin Syndrome
  • Device Use
  • Pregnancy

PATIENT PACKAGE INSERT

  • Who should not take Zomig Nasal Spray?
    • sumatriptan/naproxen (Treximet) [added]
    • Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake
      inhibitors (SNRIs)...
  • What are the possible side effects of Zomig Nasal Spray?
    • Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use Zomig...

CONTRAINDICATIONS

Peripheral Vascular Disease:

Zomig should not be given to patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions (5.4)]

WARNINGS AND PRECAUTIONS

Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events - Cardiac Events and Fatalities with 5-HT1 Agonists:

...Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to Prinzmetal’s variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur...

Cerebrovascular Events:

...As with other acute migraine therapies, before treating
headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions...

Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia:

Very rare reports of transient and permanent blindness and significant partial vision loss have been reported...

Serotonin Syndrome:

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including Zomig treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with Zomig and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) [See Drug Interactions (7.5)].

Label approved 10/14/2008 is not available on this site

Hide
(web3)