Dermatological adverse drug reactions in tertiary care hospital: an analysis of causality and severity

Background: Dermatological adverse drug reactions (ADRs) are easily detected by patients and that precludes further usage of drugs. So, decided to study the pattern, causative drugs, severity of adverse drug reactions and their causality in tertiary care hospital.Methods: It was prospective non inventional cross sectional study. Patients attending OPD or admitted to IPD of all age group and both gender with suspected dermatological ADRs following drug intake were included and the ADRS were recorded on CDSCO’s Pharmacovigilance form. Collected data was analyzed for assessment of causality using WHO-UMC scale, for severity by using Modified Hartwig and Siegel. Morphological pattern, drug groups, gender and age distribution was analyzed.Results: 231 dermatological ADRs were recorded and analyzed. Maximum cases were found in 21-30 years age group (74 cases). Dermatological ADRs were found in 143 females and in 88 males. Three major classes of drugs found responsible for causing dermatological ADRs were -oral Antimicrobials-41 (17.75%) and Injectable Antimicrobials-40 (17.32%), NSAID's-40 (17.32%.) and Topical Betnovate-36 (15.58%.). Regarding the type, 95 cases were of maculopapular rashes (41.12%), steroid damaged face in 42 (18.18%) andacute urticaria in 20 (8.65%). In terms of Severity assessment, authors found 23 cases (9.95%) as Mild, 176 cases (76.19%) of moderate severity and 32 cases (13.85%) of Severe category. In terms of causality assessment: 3 cases as Certain, 68 cases as Probable and 160 cases as Possible.Conclusions: From this study, it was found maximum Dermatological ADRs of moderate severity and few cases of causality category as “Certain”

Study of interaction of nifedipine with haloperidol on conditioned avoidance response and catalepsy in rats

Background: To study the interaction of calcium channel blocker (Nifedipine) with Antipsychotic drug (Haloperidol) on Conditioned avoidance Response and catalepsy in Rats.Methods: Every group consisted of 10 healthy albino rats of either sex. Different groups received Nifedipine (5, 10 & 20 mg/kg, i.p.), Haloperidol (ED50 -0.2mg/kg for CAR & 0.4mg/kg for catalepsy) alone and combined doses of both drugs. The Antipsychotic effect of drugs was measured by Conditioned avoidance response (CAR) using Cook’s Pole climbing apparatus and Adverse drug effect (Extra pyramidal syndrome) was measured by Catalepsy.Results: 5 mg/kg i.p. of Nifedipine inhibited CAR in 50 % of Rats (compared to control, p<0.001). 10mg/kg i.p. of Nifedipine inhibited CAR in 60% of Rats (p<0.001) & 20 mg/kg i.p. inhibited CAR in 70% of Rats (p<0.001). When Nifedipine (5 mg/kg i.p) was combined with Haloperidol ED50-0.2mg/kg  the CAR was inhibited in 70% of the rats (p<0.01) and after combining Nifedipine (10mg/kg) with Haloperidol ED50-0.2mg/kg the CAR was inhibited in 80% Rats (p<0.001). Nifedipine at the dose of 5 mg/kg and 10 mg/kg (i.p.) did not induce catalepsy in the rats at any testing time interval.  At 20 mg/kg i.p., it produced catalepsy in 2 rats at half hour and in 4 rats at 1 hour and 2 hour testing interval each (p<0.01). In the dose of 5, 10 and 20 mg/kg, pretreatment with Nifedipine significantly increased Haloperidol induced cataleptic scores at all testing intervals (p<0.05).Conclusions: Nifedipine blocked CAR. Its higher doses induced catalepsy and it is synergistic with haloperidol in blockade of CAR and catalepsy