The drug thalidomide has a long FDA history. It was approved in Europe in 1957, but was rejected for approval in the United States because of concerns about neuropathy associated with use of the drug. While the Agency was awaiting answers to these concerns, the link between thalidomide use and an epidemic of congenital malformations was recognized and the drug was then withdrawn form marketing.

Because of the toxicity of this drug and in an effort to make the chance of fetal exposure to thalomid as negligible as possible, it will be approved for marketing only under a special restricted distribution program approved by the FDA. This program is called the "Steps for Thalidomide education and Prescribing Safety" or STEPS. Under this restricted distribution program, ONLY prescribers and pharmacists registered with the program are allowed to prescribe and dispense the product.

The side effects associated with Thalomid include:
birth defects, drowsiness and somnolence, peripheral neuropathy, dizziness and orthostatic hypotension, neutropenia, increased HIV-Viral load, hypersensitivity and Bradycardia. It has also been reported to enhance the sedative activity of barbituates, alcohol, chlorpromazine and reserpine.