BACKGROUND: To improve the public health and promote instant adverse drug reaction (ADR) reporting, a need to develop an ADR Pharmacovigilance Programme of India (PvPI) mobile app was identified by the National Coordination CentrePvPI (NCCPvPI) to serve the Pan India ADR reporting. The objective of this study was to develop an indigenous Googlebased Android mobile application known as “ADR PvPI” and to analyze the ADRrelated data reported through this mobile application on pilot basis. MATERIALS AND METHODS: The ADR PvPI mobile application was indigenously developed by NCCPvPI officials within 6 months. The study of spontaneous ADR reporting was carried out between September 2017 and September 2018. This article provides an overview of the salient features of ADR PvPI mobile application, guides on how to fillin ADRs, reporting trends of ADR, types of ADR as per System Organ Class and pharmacological classes of drugs. RESULTS: Till date, >5500 users have downloaded the app with an average rating of 4.26. In that tenure, 262 reports have been received through ADR PvPI mobile app. During the year 2017, 3.55% of reports were received through ADR PvPI mobile app and the percentage of reports received by 2018 was 96.45%. CONCLUSION: The frequency of ADR reporting has significantly increased over the past 1 year and should be promoted further through awareness and training programs.

Pharmacovigilance of vaccines is of paramount importance to promote the safe use of vaccines among their recipients. India launched the Adverse Events Following Immunization (AEFI) surveillance program in 1986 for monitoring suspected adverse events following immunization and since then, the AEFI surveillance guideline has been updated periodically, with the latest being in 2015. The successful AEFI surveillance program in India required the concerted effort of all stakeholders such as National AEFI Secretariat, National Technical Collaborating Centre, Central Drug Standard Control Organization, marketing authorization holder, and health-care professionals.

OBJECTIVE: To determine prevalence of methylenetetrahydrofolate reductase (MTHFR) mutations in apparently healthy individuals residing in Mumbai and patients with deep vein thrombosis (DVT) and coronary artery disease (CAD) and to correlate these polymorphisms with homocysteine (Hcy) levels. MATERIALS AND METHODS: This case–control study was initiated after receiving ethical approval and following the participant's written consent. One hundred and twenty unmatched healthy volunteers and 240 patients with arterial and venous thrombosis were enrolled. The prevalence of C677T and A1298C MTHFR mutations was detected using polymerase chain reaction-restriction fragment length polymorphism technique. Serum Hcy concentration and lipid levels were determined using biochemical kits. RESULTS: Allele frequency of 677T was 7%, 15%, and 14% in healthy controls, DVT, and CAD patients, respectively, while for 1298C allele, it was 31%, 33%, and 29%, respectively. The lipid markers in CAD patients were significantly low in comparison to the controls while the Hcy level in patients with thrombosis was higher in comparison with the controls. Highest Hcy levels were observed in participants with TT genotype followed by CT genotype and CC genotype in all the three groups. A higher risk of raised Hcy levels was seen in the variants (CT + TT) as compared to CC genotype in DVT (odds ratio [OR] = 3.39, 95% confidence interval [CI] = 1.39–8.2,P < 0.01) and CAD (OR = 21.67, 95%CI = 4.87–96.47,P < 0.0001). The risk observed for A1298C was 2.28 and 2.12 times higher in variants (AC + CC) of both DVT and CAD (OR = 2.28, 95%CI = 1.09–4.75 and OR = 2.12, 95%CI = 1.02–4.40, respectively). CONCLUSIONS: The prevalence of variants was more in thrombosis patients as compared to unmatched controls. Our study highlights the fact that MTHFR C677T polymorphism as compared to A1298C significantly affects Hcy levels in patients with thrombosis indicating that patients with mutant variants are at higher risk of rapid progression of their disease condition.

CONTEXT: Migraine is the second most common headache disorder. However, prophylactic therapy remains underutilized. AIMS: The objective of the study was to compare the efficacy and safety of low-dose sodium valproate and low-dose propranolol sustained release (SR) in the prophylaxis of common migraine headache. SETTINGS AND DESIGN: The study was conducted in a tertiary care teaching institute. It was a randomized, prospective, parallel, open-label, clinical study. SUBJECTS AND METHODS: The study included 60 patients with common migraine headaches (≥2 attacks/month) treated for 12 weeks. The patients were randomly divided into two treatment groups treated by sodium valproate 500 mg/day and propranolol SR 40 mg/day, respectively. The primary outcome measures were the percentage of responders (i.e., >50% decrease in mean headache frequency) at the end of 12 weeks and decrease in mean headache frequency (per 4 weeks) at the end of 12 weeks. The patients were assessed at 0, 4, 8, and 12 weeks of the study. STATISTICAL ANALYSIS USED: Intention-to-treat analysis was used for all the statistical analysis. RESULTS: Fifty-five patients completed the study. At the end of the treatment, both sodium valproate and propranolol caused a significant (P < 0.0001) reduction in frequency, severity, and duration of migraine headache. Propranolol caused significantly greater reduction in the severity of headache (P = 0.0410) than sodium valproate. The percentage of responders was 60% in sodium valproate group and 70% in propranolol group. Drowsiness was the most common adverse effect noted in both the groups. CONCLUSION: Both sodium valproate and propranolol significantly reduced frequency, severity, and duration of migraine headache, but propranolol caused significantly greater reduction in the severity of headache compared to sodium valproate. Both the medications were well tolerated and did not result in discontinuation.

INTRODUCTION: As a chronic, progressive, and lethal pulmonary disease, chronic obstructive pulmonary disease (COPD) is lacking effective treatment. Chronic inflammatory processes, including inflammatory cytokines, play an important role with in its pathogenesis. Jianpiyifei (JPYF) granule is a traditional Chinese herbal formula historically used to strengthen the spleen and tonify the lung. JPYF is used clinically to treat stable COPD. However, whether the purported anti-inflammatory effect of JPYF in COPD involves regulation of key inflammatory cytokines is not clear. MATERIALS AND METHODS: The mice model of pulmonary inflammation was induced by lipopolysaccharide (LPS) and cigarette smoke condensate (CSC). The influence of JPYF on airway inflammation in vivo was investigated. Mice were divided into three groups: control, model, and treatment groups. In the CSC + LPS model group and JPYF treatment group, intratracheal injection of CSC and LPS was used to induce airway inflammation for 5 days. JPYF group animals were also orally administered 5.5 g/kg JPYF granule for 12 days. RESULTS: The number of neutrophils and total cells in bronchoalveolar lavage fluid of the JPYF group were markedly lower than in the model group. The levels of interleukin (IL)-1 β and IL-6 were lower; tumor necrosis factor-alpha was downregulated, and IL-10 was higher in the JPYF group than the model group. In the JPYF group, histone deacetylase 2 (HDAC2) activity and protein expression were restored. CONCLUSION: The anti-inflammatory activity of JPYF involves the suppression of pro-inflammatory cytokines, enhanced IL-10 secretion, and the restoration of HDAC2 activity.

OBJECTIVES: Metabolic and endocrine adverse effects are among the most concerning unfavorable consequences of commonly used psychotropic drugs. The present research was planned to assess and determine the effects of haloperidol and clozapine on testosterone, cortisol, and corticosterone levels and also their influence on androgen-dependent organs in adult male Wistar rats. MATERIALS AND METHODS: Animals were casually distributed into three groups (n = 10 in each group). Drugs were administered intraperitoneally for 28 days. The control group received 2 mL of physiological saline, the second group received haloperidol (0.5 mg/kg), and the third group received clozapine (0.5 mg/kg). The subsequent testosterone, cortisol, and corticosterone plasma concentration levels were analyzed with chemiluminescent immunoassay. RESULTS: Clozapine and haloperidol treatments altered testosterone hormone levels. Testosterone mean values in both the clozapine (1.00–0.58) and haloperidol (0.65–0.62) groups were found to be lower than compared to controls (P = 0.003, P < 0.001). Histomorphometric analysis results also showed reduced testes size and reduced weight of androgen-dependent organs in drug-treated rats. CONCLUSION: It can be suggested that clozapine and haloperidol are effective in reducing the testosterone plasma concentration level and androgen-dependent organ sizes; therefore, clinicians should be aware of these effects when considering the use of antipsychotic drugs.

Lurasidone is a newer drug used for treating schizophrenia and depression in bipolar disorder. Although comparatively safe, some side effects can occur with its use such as akathisia, extrapyramidal reaction, metabolic syndrome, and hyperprolactinemia. Blood dyscrasia with lurasidone is rarely reported in the literature except for few case reports. We present two cases of schizophrenia, treated with lurasidone developing anemia after variable period of treatment and reverting after stopping lurasidone. These cases emphasize the timely monitoring of blood parameters for prevention or early detection of anemia in patients treated with lurasidone.

Various adverse drug reactions, including hypersensitivity skin reaction after the exposure to carmoisine colorant, have already been reported in the literature. This case report gives the details of a 5-year-old male child with a recurrent fixed drug eruption (FDE) over the neck and trunk after the use of paracetamol syrup containing carmoisine as a colorant. Patch test to the carmoisine colorant in the paracetamol syrup was positive. This case report adds an increased awareness of the probability of allergic skin reaction to carmoisine in a previously sensitized person. The report also emphasizes the necessity to consider artificial dyes in pharmaceutical products as a potential cause for FDE.