BlackBoxRX
 
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Danazol

Pregnancy Contraindication; Stroke Risks; Benign Intracranial Hypertension

  • Contraindicated in Pregnancy(see package insert for specific recommendations to ensure adherence that patient is not pregnant)
  • Thromboembolism and thrombotic events including life-threatening or fatal strokes have been reported
  • Peliosis hepatitis and benign hepatic adenoma have been observed with long term use.  Attempts should be made to determine the lowest dose to provide adequate protection.
  • Benign Intracranial Hypertension (Pseudotumor cerebri) has been reported
  • Screen for early signs of intracranial hypertension (e.g. headache, nausea, vomiting, visual disturbances).  Patients with these symptoms should be screened for papilledema and, if present, should be advised to discontinue the drug immediately and be referred to a neuorologist for further care and diagnosis.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Negative pregnancy test immediately prior to therapy
  • Nonhormonal method of contraception recommended during therapy
  • Exposure during pregnancy requires patient appraisal of potential risks.
  • Use lowest dose that will provide adequate protection
  • Screen for early signs of intracranial hypertension (e.g., headache, nausea, vomiting, visual disturbances)

Package Inserts

Danazol

Additional Information

Updated January 2018