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U.S. Department of Health and Human Services

Safety

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Amerge (naratriptan) Tablets

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

 

October 2013

Summary View

CONTRAINDICATIONS

  • Hypersensitivity to Amerge (angioedema and anaphylaxis seen).

WARNINGS AND PRECAUTIONS

Increase in Blood Pressure
  • Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Amerge. Amerge is contraindicated in patients with uncontrolled hypertension.
Anaphylactic/Anaphylactoid Reactions
  • There have been reports of anaphylaxis and anaphylactoid and hypersensitivity reactions, including angioedema, in patients receiving Amerge. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Amerge is contraindicated in patients with a history of hypersensitivity reaction to Amerge. 

 

March 2012

Summary View

PRECAUTIONS

  • Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. Migraine patients should be informed about the risks of medication overuse and encouraged to record headache frequency and drug use.