Affiliations: C. U. Shah College of Pharmacy, SNDT Women's University, Mumbai, India | Department of Medicine, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India | National Chair Clinical Pharmacology, Indian Council of Medical Research, Dean, ESI-PGIMSR, Govt. of India, MGM Hospital, Parel, Mumbai, India
Note: [] Address for correspondence: Dr. N.A. Kshirsagar, National Chair Clinical Pharmacology, Indian Council of Medical Research, Dean, ESI-PGIMSR, Govt. of India, MGM Hospital, Parel, Mumbai-400012, India. Tel.: 9821036616; Fax: 022-24142101; E-mail: [email protected]
Abstract: Objective: To collect data on suspected adverse drug reactions of HAART therapy; analyze the data; and find out frequency of preventable adverse drug reactions in order to minimize the harm to the patients. Design: Retrospective study. Methods: ADR data associated with the use of HAART from November 2005 to December 2007 was collected retrospectively from records of patients using the ART treatment from NACO at a tertiary referral centre under the National Pharmacovigilance Programme. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale) and preventability (Schumock and Thornton scale). Results: Data of 1844 patients (1198-Male & 645-Female) enrolled from November 2005 to December 2007 was collected. 222 patients developed about 228 ADRs with prevalence of 12.36%. Peripheral neuropathy and anemia were highly prevalent ADRs. Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART. 96.49% ADRs were found to be possible and 3.50% probable by WHO probability scale. 20 (8.77%) were mild, 176 (77.19%) were moderate and 32 (14.02%) were severe in nature. 183 (80.26%) ADRs were found to be non-serious whereas 45 (19.74%) were serious. Only 2.63% ADRs were found to be preventable which included vomiting and rash. Odds ratio with 95% CI was calculated. Conclusion: It has been observed that antiretroviral therapy has many serious and life threatening adverse drug reactions that may affect a variety of organ systems. Zidovudine use was observed as a risk factor for anemia. Stavudine for peripheral neuropathy, where as nevirapine use was identified as a risk factor for skin reactions. Active pharmacovigilance programme should be implemented and awareness should be created among physicians about reporting any suspected adverse drug reaction so that unreported ADRs and unknown risk factors could be identified.
Keywords: Pharmacovigilance, antiretroviral therapy, adverse drug reactions
