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isotretinoin Images

Generic Name: isotretinoin

Brand Names: Sotret, Claravis, Amnesteem, Accutane

There is an FDA Alert for this drug. Click here to view it.

  • Known human teratogen; extremely high risk of severe birth defects if administered during pregnancy; may be life-threatening. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
  • iPLEDGE restricted distribution program is in effect to help ensure that fetal exposure does not occur. The iPLEDGE program specifies monthly requirements for the prescribing clinician, patient, and pharmacist. (See Restricted Distribution under Dosage and Administration.)
  • Contraindicated in female patients who are or may become pregnant and in female patients of childbearing potential, unless they comply with all the special conditions required by the iPLEDGE restricted distribution program.
  • Pregnancy must be excluded by monthly negative serum or urine pregnancy test results and prevented by simultaneous use of 2 forms of reliable contraception. (See Advice to Patients.)
  • If pregnancy occurs, immediately discontinue drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. (See Pregnancy under Cautions.)

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