System for Thalidomide Education and Prescribing Safety

To prevent severe birth defects and possible death of the newborn child, when thalidomide is used in women of child-bearing age or in sexually active men (due to levels of thalidomide in semen) adherence to strict guidelines adopted by the FDA is required. The specific guidelines fall under the term S.T.E.RS. program or System for Thalidomide Education and Prescribing Safety . All prescribers (physicians) and distributors (pharmacists, etc.) must register and adhere to these guidelines. Other toxicides include headache, dizziness, rash, pruritis, drowsiness, somnolence, peripheral neuropathy, leucopenia, and venous thrombosis. 

STEPS—System FOR Thalidomide Education and Prescribing Safety... 

Drugs that are clearly contraindicated in pregnant women are isotretinoin and thalidomide as indicated hy the nse of these products with distribution programs such as iPLEDGE (a computer-based risk management program) and STEPS (System for Thalidomide Education and Prescribing Safety). 

Recently, thalidomide has gained approval for use in the United States as an immunomodulatory agent in the treatment of HIV-associated diseases, arthritis, myeloma, and diabetic retinopathy. The FDA has instituted the System of Thalidomide Education and Prescribing Safety (STEPS) to prevent accidental exposures during pregnancy. 

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