Author(s): Danturulu Muralidhar Varma , Radhakrishnan Rajesh *, Poornima Pulagam , Sudha Vidyasagar , Vasudeva Guddattu
In India, HIV patients are at a high risk of developing hematological and
dermatological adverse drug reactions (ADRs) leading to financial burden.
Materials and Methods:
A prospective observational study was conducted on hemato-
logical and dermatological ADRs in a South Indian teaching hospital from October
2011 to October 2012. The definition of ADRs established by the World Health Organi-
zation (WHO) was used to assess the causality. Predictability of ADRs was assessed by
Micromedex database. Preventability of ADRs was assessed using the Schumock and
Thornton criteria.
Results:
A total of 174 HIV patients were enrolled [133 (76.4%)
males and 41 (23.6%) females], who reported 99 ADRs to HAART. Of the total ADRs,
70 (70.7%) were reported in males and 29 (29.3%) in females, indicating significantly
higher reporting of ADRs in males. 67 of the 99 ADRs were hematological, while the
remaining 32 were dermatological. A high number of hematological [40 (59.6%)] and
dermatological [15 (46.8%)] ADRs were reported for zidovudine + lamivudine +
nevirapine-based HAART regimen. In most of the reported ADRs, the suspected drug
was withdrawn. The reported hematological ADRs were as follows: 1) anemia with
zidovudine [35 (52.2%)]; 2) pancytopenia with zidovudine [20 (29.9%)]; 3) neutrope-
nia with lamivudine; and 4) leucopenia, bicytopenia, and eosinophilia with zidovudine.
Dermatological ADRs were maculopapular rash [7 (21.8%)] with nevirapine-, tenofo-
vir + emtricitabine + efavirenz