title: Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.
abstract: OBJECTIVE
  Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009.
  
  
  METHODS
  A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7 person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be "ruled out."
  
  
  RESULTS
  It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were "hyperlipidemia," "nausea," "increased γ-glutamyltransferase level," "increased blood triglycerides," "abnormal hepatic function," and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion).
  
  
  CONCLUSIONS
  During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance.
authors.affiliation: ViiV Healthcare K. K., Tokyo, 151-8566, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Kurita
authors.forename: Tomomi
authors.initials: T
authors.lastname: Kitaichi
authors.forename: Takako
authors.initials: T
authors.lastname: Nagao
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Miura
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Kitazono
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015224:Dideoxynucleosides / Q000009:adverse effects* / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D018894:Reverse Transcriptase Inhibitors; D000099227:Abacavir
keywords: Japanese; abacavir; adverse drug reactions; human immunodeficiency virus; hypersensitivity; myocardial infarction; pharmacoepidimiology