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U.S. Department of Health and Human Services

Safety

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Adenoscan (adenosine) Injection

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

 

August 2014

Summary View

(note: change to PLR format)

WARNINGS AND PRECAUTIONS

  • Cerebrovascular Accident Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenoscan including hypotension or hypertension can be associated with these adverse reactions.
Seizures
  • New-onset or recurrence of convulsive seizures has occurred following Adenoscan. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenoscan. Methylxanthine use is not recommended in patients who experience seizures in association with Adenoscan administration
Hypersensitivity
  • Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Symptomatic treatment may be required. Have personnel and appropriate treatment available. Resuscitative measures may be necessary if symptoms progress.

ADVERSE REACTIONS

  • Cerebrovascular Accident
  • Seizures
  • Hypersensitivity
Postmarketing Experience
  • *Some headers renamed*
  • Cardiac disorders: ….atrial fibrillation, cardiac failure…tachycardia..
  • General Disorders and Administration Site Conditions: chest pain, … infusion site pain
  • Immune system disorders- hypersensitivity
  • Respiratory, Thoracic and Mediastinal Disorders: bronchospasm….

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • It is not known whether Adenoscan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Adenoscan in nursing infants, the decision to interrupt nursing after administration of Adenoscan or not to administer Adenoscan, should take into account the importance of the drug to the mother.

PATIENT COUNSELING INFORMATION

  • *Patient Counseling section added*

 

February 2011

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • throat tightness