Retrovir® (Zidovudine): A Unique Drug Information Challenge

On Sep 19, 1986, the first placebo-controlled clinical trial with Retrovir® (zidovudine, formerly AZT) was terminated due to significantly higher mortality among placebo-treated patients. A unique set of procedures and guidelines was established to process a high volume of information requests and also to handle unique, nontraditional drug information requests. On March 19, 1987, the US Food and Drug Administration (FDA) approved zidovudine for sale in the United States. At the time of approval, a shortage of the drug required a limited distribution program to be instituted. The distribution system also made a dramatic impact on zidovudine drug information requests. From February 1987 through January 1988 a total of 31,775 telephone inquiries were processed and 4,294 pieces of written information were distributed to the medical and lay communities. The unique procedures established to process these information requests are outlined.