title: Bleeding episodes in HIV-positive patients taking HIV protease inhibitors: a case series.
abstract: In July 1996 the Food and Drug Administration (FDA) alerted healthcare providers about 15 case reports of spontaneous bleeding episodes in HIV-positive haemophiliacs taking HIV protease inhibitors. In order to characterize the bleeding associated with HIV protease inhibitor therapy, the FDA's spontaneous adverse event reporting system was searched through 28 February 1997. The bleeding episode reporting rate for persons with haemophilia was compared for HIV protease inhibitors and zidovudine, and the characteristics of haemorrhagic events were compared between individuals with and without haemophilia. There was a substantial predominance of bleeding episodes for haemophiliacs taking HIV protease inhibitors (39 of 67; 58%) as compared with zidovudine (two of 63; 3.2%). A comparison of 39 reports of bleeding in haemophiliacs with 28 in non-haemophiliacs revealed similarities in time to event and type of HIV protease inhibitor implicated, but differences were present concerning location of bleeding and outcome. A greater proportion of haemophiliacs had resolution of their bleeding following discontinuation of their HIV protease inhibitor and recurrence of bleeding following rechallenge, as compared with non-haemophiliacs. HIV-positive haemophiliacs appear to be at an elevated risk of bleeding while taking HIV protease inhibitors, but these medications may predispose all individuals to such complications.
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Racoosin
authors.forename: C M
authors.initials: CM
authors.lastname: Kessler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016208:Databases, Factual; D005260:Female; D017320:HIV Protease Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006679:HIV Seropositivity / Q000150:complications* / Q000188:drug therapy; D006467:Hemophilia A / Q000150:complications*; D006470:Hemorrhage / Q000209:etiology* / Q000517:prevention & control; D006801:Humans; D019469:Indinavir / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D019888:Nelfinavir / Q000494:pharmacology; D019258:Saquinavir / Q000494:pharmacology; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D017320:HIV Protease Inhibitors; D015215:Zidovudine; D019469:Indinavir; D019888:Nelfinavir; D019258:Saquinavir