ABSTRACT
Background: Incidence of cutaneous adverse drug reactions (CADRs) in developed countries is 1 to 3% and in developing countries, it is much higher i.e. 2 to 6%. 1 in 1000 hospitalized patients will develop severe cutaneous adverse reaction. Maculopapular rash represents majority of cutaneous drug reaction followed by urticaria. Most frequently elicited CADRs are associated with antimicrobials and NSAIDs. This study was designed to monitor Cutaneous adverse drug reaction profile of tertiary care teaching hospital.Methods: This is a prospective observational study of 6 months� duration to monitor cutaneous adverse drug reactions in dermatology department of tertiary care teaching hospital. CADRs were analysed with respect to demographic details, suspected drugs and type of reaction. Causality assessment is by Naranjo algorithm. Data is represented in tables and graphs. Data is analyzed in Microsoft excel 2007.Results: Total 57 cases of cutaneous adverse drug reactions were reported. Among them, 57.9% were in males and 42.1% were in females. Majority of CADRs were due to antiretroviral drugs (38.5%) followed by antibacterial (28%) and antiepileptics (14%). Maculopapular rash is most common CADR (35%). Causality of 74% CADRs were probable according to Naranjo algorithm.Conclusions: CADRs are more commonly associated with antiretroviral therapy (ART), antibacterial drugs and antiepileptic drugs. In case of ART, antiepileptic drug and drugs used in chronic illness compliance plays a major role in the success of therapy. Adverse drug reactions lead to problem of non compliance and failure of therapy. Cutaneous adverse reactions like FDE heal with hyper pigmentation leads to cosmetic problem. Stevens Johnson syndrome (SJS) is life threatening that requires prompt withdrawal of drug and intensive medical management. Many drugs are available without prescription in India leading to problem of misdiagnosis of CADRs. So, data obtained from this study helps in proper diagnosis and treatment of CADRs.
ABSTRACT
Background: In 2016, FDA recommended that 搒erious side effects associated with flouroquinolones generally outweigh the benefits for the patients with acute sinusitis, acute bronchitis and uncomplicated UTI�. Throughout India the most commonly used flouroquinolones for above conditions are Ciprofloxacin, Ofloxacin, and Levofloxacin. In this scenario, the present study was undertaken to monitor, evaluate and compare the adverse effect profile of Ciprofloxacin and Ofloxacin in acute exacerbation of chronic bronchitis patients.Methods: Prospective, observational study done in 200 patients of tertiary care teaching hospital. The patients diagnosed with, acute bronchitis treated with Ciprofloxacin 500mg BD or Ofloxacin 400mg BD for 7 days were included in the study. The study duration was 6 months. ADR causality assessment was done with Naranjo algorithm. Statistical test applied was chi- square test.Results: 63 ADR were reported in Ofloxacin group and 19 ADR in Ciprofloxacin group. Insomnia was most frequent ADR (40%) in patients treated with Ofloxacin. There is high incidence of ADRs in ofloxacin group. chi square test showed this difference is statistically significant (p<0.05). Insomnia was significantly higher in ofloxacin group (p<0.05).Conclusions: In India frequently used and misused antimicrobials are fluoroquinolones. The present study concluded that no serious ADRs but ofloxacin group of patients have shown increased incidence of ADRs associated with CNS especially Insomnia. However, further large scale, multi-centric studies are needed to confirm these results.