AEGiS-GMHC: TREATMENT BRIEFS: d4T Side Effects

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

TREATMENT BRIEFS: d4T Side Effects

Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 9 - October, 1993
David Gold

Bristol Myers Squibb, the New York-based drug company that manufactures d4T, reports that over 7,000 patients have participated in its expanded access program for d4T, a new anti-HIV nucleoside analog. Another 1,000 patients are participating in clinical trials of the drug. According to the company's June 1993 quarterly safety summary of all patients taking d4T, 43 cases of pancreatitis have been reported, including three pancreatitis-associated deaths. The company claims that the pancreatitis occurred in patients who received concurrent medications known to cause pancreatitis (such as IV or aerosolized pentamidine) or had a history of chronic alcohol abuse. The quarterly report advises physicians to continue to "exercise caution in the monitoring of patients on the parallel track program at high risk of pancreatitis, such as those with a prior history of the condition, or those receiving medicinal agents known to be associated with pancreatitis." In addition, in a letter to physicians, the company indicated that there were some anecdotal reports of insomnia and irritability in a number of individuals on the d4T expanded access program. However, the company points out the safety board has determined that "no safety issues were apparent that would prevent the programs from continuing." Individuals on the d4T access program are encouraged to report all side effects to their physicians. The company expects to submit a New Drug Application (NDA) for licensing approval of d4T in December 1993.

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