Just one pill can cause horrific birth defects. Only doctors and pharmacists trained in thalidomide's dangers by manufacturer Celgene Corp. will be allowed to prescribe or dispense it.
Women can receive thalidomide only after a negative pregnancy test.
For the first month of thalidomide therapy, women must undergo repeat pregnancy tests every week. Thereafter, women are tested monthly before every refill, or every two weeks if they have irregular menstrual cycles. Before prescribing, doctors must reveal thalidomide's dangers and instruct patients to use effective birth control. Men are told to use condoms, because thalidomide might be carried in semen. Women are told to use two forms of birth control, a hormonal method like the pill plus a barrier method such as condoms, and are to be prescribed contraception as necessary.