Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India.

AIM OF STUDY: To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period. MATERIAL AND METHODS: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI). RESULTS: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin+ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR's were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention. CONCLUSION: The current study suggest that ADRs due to antimicrobials is a significant health problem.

Hepatoprotective activity of Vitex negundo leaf extract against anti-tubercular drugs induced hepatotoxicity.

Hepatoprotective (HP) activity of Vitex negundo (VN) leaf ethanolic extract was investigated against hepatotoxicity (HT) produced by administering a combination of three anti-tubercular drugs isoniazid (INH)-7.5 mg/kg, rifampin (RMP)-10 mg/kg and pyrazinamide (PZA)-35 mg/kg for 35 35 days by oral route in rats. V. negundo leaf ethanolic extract was administered in three graded doses of 100, 250 and 500 mg/kg orally, 45 min prior to anti-tubercular challenge for 35 days. HP effect of V. negundo leaf ethanolic extract was evident in the doses of 250 and 500 mg/kg as there was a significant decrease in TB, AST, ALT and ALP levels in comparison to control. Histology of the liver section of the animals treated with the V. negundo leaf ethanolic extract in the doses of 250 and 500 mg/kg further confirms the HP activity.

Comparative effects of conventional B-blockers and nebivolol on psychomotor performances in healthy volunteers: a preliminary report.

The present study was under taken to assess the comparative effects of nebivolol with propranolol and atenolol on psychomotor performances. Thirty healthy volunteers were randomized into three groups with n=10 in each group. Each subject received single dose of one of the three medications (nebivolol 5 mg, atenolol 50 mg and propranolol 40 mg) in morning (9:00 AM). Just before administering the drug, the pre-drug scores were taken, followed by post drug score obtained for consecutive six hours. Psychomotor assessment was carried out by three tests Simple Reaction Timer (SRT), Critical Flicker Fusion Frequent Threshold (CFFT) and Digit Cancellation Test (DCT). The results of present study indicate that single doses of atenolol and propranolol produced significant impairment of psychomotor performance. Nebivolol also impaired psychomotor performance tests in the similar fashion to atenolol and propranolol. Hence, the findings of the present study correlate with the lipophilic nature of the nebivolol.

Effects of tamoxifen therapy on plasma lipid profile in patients of breast cancer.

AIM: To evaluate the effects of tamoxifen therapy on plasma lipid profile in patients of breast cancer. METHOD: A total of 55 postoperative patients of breast cancer were given tablet tamoxifen 20mg orally daily for 6 months. Estimation of plasma lipid by standard method was carried out in both pre-menopausal and postmenopausal new patients of early stage breast cancer at 0 day, 3rd month and 6th months of therapy. RESULTS: Suggested that in pre-menopausal and postmenopausal patient's TC and LDL-c levels were reduced significantly, whereas, TG, VLDL-c and HDL-c were not altered. Comparison of the effects of tamoxifen in pre-menopausal and postmenopausal patients on lipid profile revealed that fall in TC and LDL-c was significantly higher at both 3 and 6 months in postmenopausal patients. CONCLUSION: The study demonstrates that tamoxifen to favorably alter the markers of cardiovascular risk in both pre-menopausal and postmenopausal patients of breast cancer.

Anhidrotic Ectodermal Dysplasia (Christ-Seimens-Touraine syndrome)--case report with a review.

Anhidrotic ectodermal dysplasia commonly transmitted as an x-linked recessive disorder is very rare. The complete syndrome occurs in males and females are carriers. Our patients comprised two sisters who had the complete syndrome. This is much rarer and is reported to be inherited as autosomal recessive disorder, there are only a few case reports of females presenting with a complete syndrome in the literature.

Studies on psychomotor performance in healthy volunteers after diazepam, propranolol and alcohol given alone or in combination.

The effects of diazepam, propranolol or alcohol alone or in combination with each other were examined in ten normal healthy volunteers on tests of psychomotor function. Results showed impaired psychomotor performance persisting upto 4-5 h when the aforementioned agents given singly were tested on simple reaction time (SRT), multiple choice reaction time (MCRT) and critical flicker fusion frequency (CFFF) tasks. Digit cancellation task (DCT) was similarly affected by diazepam and alcohol only. No summation of adverse effects on psychomotor performance was noted when a combination of diazepam and alcohol, diazepam-propranol or alcohol plus propranolol were tested on SRT and MCRT. An additive impairment of CFFF was observed with alcohol - propranolol combination only. No summation of pharmacodynamic effects on DCT were noted when different combinations were used.