Pattern of central nervous system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India

Abstract

Background: Anti-retroviral therapy is associated with myriads of side-effects. Central nervous system related side effects are troublesome and mostly self limiting. Working knowledge of these side effects can improve the prescription habits of physicians. The study aimed pattern of central system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India. Materials and methods: A prospective observational study was conducted and all HIV positive patients, previously registered and new; attending OPD who encountered ADRs were enrolled in our study irrespective of their age and sex. Data was collected using ADR reporting form issued by Indian Pharmacopoeia Commission. Causality assessment was done by using Naranjo’s Probability Scale. Modified Hartwig severity scale was used to evaluate severity, WHO criteria for seriousness and guidelines of council for international organizations of medical sciences to decide the predictability of ADRs. Results: A total of 250 patients encountered various types of ADRs during the study period. Total number of ADRs recorded was 452. Out of total ADRs (n=452) recorded, 20.35% (n=92) were central system related ADRs. Most common central nervous system related ADR was dizziness. Most central nervous system related ADRs were of moderate type and possible in nature on causality assessment. Conclusion: Relatively overweight, older age and baseline CD4 absolute count below 250 cells/mm3, were predictors for central nervous system related side effects due to anti-retroviral therapy in HIV patients. We suggest that more stringent evaluation and monitoring should be carefully done in all HIV/AIDS patients who will receive and on efavirenz based anti-retroviral therapy, especially if they have the above predictors.

Keywords

• central nervous system
• adrs
• hiv
• anti-retroviral therapy
• efavirenz
• cd4 count