Adverse drug reactions to antiretroviral therapy (ART): An experience of spontaneous reporting and intensive monitoring from ART centre in India

Pharmacoepidemiology and Drug Safety (Impact Factor: 2.94). 03/2010; 19(3):247 - 255. DOI: 10.1002/pds.1907


PurposeTo assess the nature, severity, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for antiretroviral ADRs.Methods
Enrolled ambulatory patients were intensively monitored for ADRs. Spontaneously reported ADRs by clinicians were also included. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for ADRs. Data from spontaneous reporting was assessed using Bayesian neural network method for possible ADR signals.ResultsMonitoring by active surveillance indentified 159 (52.82%) ADRs from 400 patients. One hundred and forty-two (47.17%) reactions were spontaneously reported. Anaemia and vomiting were the most commonly observed ADRs. The ADRs were severe in 10.9% of cases. A total of 88% ADRs were definitely/probably preventable. Use of Zidovudine+Lamivudine with Nevirapine or Efavirenz, CD4 <200 cells/µl, female gender, tuberculosis and illiteracy were observed as risk factors for ADRs by bivariate analysis. Concurrent tuberculosis was the only influential risk factor for development of ADRs identified by multivariate logistic regression.Conclusion
Prevalence of ADRs in intensively monitored patients was found to be 39.7%. Tuberculosis in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretrovirals in India, ADRs to antiretrovirals require monitoring and reporting. Copyright © 2010 John Wiley & Sons, Ltd.

1 Follower
36 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objectives: To identify the adverse drug reactions (ADRs) to antiretroviral therapy (ART) and to assess their impact on treatment compliance in patients with HIV/AIDS. Materials and methods: Two hundred and thirty-five (235) AIDS patients who received ART were monitored for ADRs over a period of 6 months. The incidence and nature of ADRs occurring with different ART regimens were recorded. We also assessed the severity, causality as well as the impact of ADRs on the patients' compliance. Results: Of 235 patients receiving ART, 90.6% patients experienced ADRs. A total of 618 ADRs involving various systems were observed. A majority were related to gastrointestinal (42.39%) and central nervous (25.57%) system. 23.1% ADRs were severe in intensity. Severe ADRs occurred in 41 out of 235 (17.4%) patients necessitating drug withdrawal. A majority of the patients (87.8%) who complained of severe ADRs received combination of stavudine, lamivudine and nevirapine. Causality assessment revealed 6.63% ADRs were probable and 93.3% ADRs were possible. Non-compliance due to ADRs was observed in 28.9% patients. Conclusions: Myriad ADRs are associated with ART which leads to poor patient compliance. With the increasing access to ART in India, it is prudent that antiretroviral drugs are used judicially with regular monitoring of ADRs.
    No preview · Article · Jun 2010 · Indian Journal of Medical Sciences
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: 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. Retrospective study. 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). 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. 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.
    Full-text · Article · Jan 2011 · The International journal of risk & safety in medicine
  • [Show abstract] [Hide abstract]
    ABSTRACT: Pharmacovigilance is concerned with the assessment of benefit and harm. Disease burden, status of healthcare delivery through government centres and practitioners, existing pharmacovigilance programmes, relevant pre-marketing studies and the likely effectiveness and risks of drugs must be considered for planning pharmacovigilance activity. The risk of a drug may be known, unknown, potential or specific to the context of the programme. The potential benefits of a public health programme aimed at reducing or eliminating a specific condition will depend on the health burden due to that condition, which is a function of the seriousness of the condition and its frequency, as well as the likely efficacy of the programme in reaching its goals. The present article has outlined an approach to pharmacovigilance for such a donor-funded programme, using pharmacovigilance in leishmaniasis as an example.
    No preview · Article · Feb 2011 · Transactions of the Royal Society of Tropical Medicine and Hygiene
Show more