ABSTRACT
Cigarette smoking is a major public health issue in India and leads to significant morbidity and mortality. Addressing the issue of smoking is a major challenge to public health, as the addiction is hard to break. Counseling smokers regarding smoking cessation is the first step to achieving cessation, but the quit rates remain low. Several pharmacological interventions have been developed over the years. Nicotine replacement therapy is available in a variety of formulations, each with different advantages, drawbacks, acceptability among smokers and quit rates. In addition, a range of novel nicotine and tobacco products, including Heated Tobacco Products (HTPs), have been developed which leverage nicotine to aid in smoking cessation. A group of medical experts convened to review the evidence on the burden of smoking, the concept of Tobacco Harm Reduction (THR), novel nicotine and tobacco products for THR, and the potential of HTPs to aid in smoking cessation. This paper outlines the findings and recommendations regarding THR in the Indian context. The panel opined that tobacco cessation centers and counseling remain the foundation of tobacco cessation in India. At the same time, there appears to be potential for the application of THR products in India. The relevant authorities must review the potential of THR products, and make these available, to provide the best possible cessation strategy for the Indian population that is currently at risk of mortality and severe morbidity.
ABSTRACT
Aim : Currently no data is available on the safety profile of COVID-19 Vaccines like Covaxin and Sputnik V from Eastern India. Our aim was to evaluate the safety profiles of Covaxin and Sputnik V Vaccine in Eastern India. Methods : 0.5 ml of Covaxin and Sputnik V given to 701 adults in a two-dose regimen at a private tertiary care Hospital, Kolkata, with the doses separated by 4-7 weeks in Covaxin and 3 weeks in Sputnik V. Data regarding local and systemic Adverse Event Following Immunizations (AEFIs) was collected 30 minutes after vaccination and also on the first- and seventh-day following vaccination after each dosage. Results : Incidence of AEFI was 65% and 59% following the first dose of vaccination in Covaxin and Sputnik V groups, respectively. Incidence of AEFI was 83% and 70% after the second dose in Covaxin and Sputnik V groups. Pain in the injection site was the most common adverse effect. Body-ache, fever and tiredness were other systemic side effects. Adverse effects were noticeably more after the second dose. Over half of the reactions were mild in nature. Covaxin had a higher number of moderate adverse reactions after both doses. Adults with age >40 years, Comorbidities, Hypertension and Diabetes had a smaller number of side effects following the first dose of vaccination. People with previous COVID-19 infections had noticeably fewer adverse effects after the second dose. Allergic adults were associated with more systemic side effects, whereas Hypertensive adults had less total AEFI. Conclusion : Both Covaxin and Sputnik V had favorable safety profiles. Sputnik V vaccine had significantly fewer AEFIs compared to Covaxin. Age, co-morbidities, specifically hypertension, Diabetes, Allergy and previous history of COVID-19 infection, were important variables observed in the prevalence of side effects.
ABSTRACT
Background: To the best of our understanding, very few studies focusing on the adverse drug reaction (ADR) profile of non-ionic contrast medium (NICM) has been carried out until date among the Indian population. Hence, this study was planned. We sincerely believe that the knowledge gathered from this study can improve safer usage of these agents among the patients of Indian origin. The objective was to evaluate the incidence and severity of ADRs of non-ionic radio contrast media (CM) used in tertiary care hospital in Eastern India. Methods: For the duration of 1-year from July 2011 to July 2012, we prospectively recorded all the ADRs associated with the administration of NICM (iohexol and ioversol) in 3708 patients of Indian origin undergoing computed tomography scan at the hospital. The average median age, weight, dose used; types of ADRs, concomitant medication, final diagnosis, reasons for use were recorded and analyzed with appropriate statistical tools. Causality assessment was performed using Naranjo scale. Results: Eleven of 3708 patients who received either ioversol or iohexol developed ADRs (i.e. 0.3% of patients). The most common ADR was rigor. The incidences of mild, moderate and severe reactions were 55%, 36% and 9%, respectively. Average median age, weight, and dose used were 35 years, 66 kg and 70 ml, respectively. All the ADRs were early (occurred within 1 hr of CM administration). Due to logical constraints, the follow-up of these patients was not possible and hence late ADRs were not captured. The common concomitant medication used was pantoprazole (63.63% of patients). The difference in the incidence of ADRs by age distribution (Group 1 - Iohexol, Group 2 - Ioversol) and weight distribution was not statistically significant (p=0.75 and p=0.18, respectively). Causality analysis revealed that all the ADRs were possible (Score of 4). Interestingly, the incidence of reactions was noted to be higher in patients with a history of gastro intestinal disorders (45.45%). Conclusions: This pilot study reveals that adverse reactions to NICM are rare and severe reactions are less common among the patients of Indian origin. However, a larger multicentric study across the country should be carried out to understand the safety profile of these CM better among the Indian population.
ABSTRACT
Chronic myeloid leukemia (CML), the most common myeloproliferative disorder, occurring due to balanced reciprocal translocation between chromosome 9 and 22 and resulting in a chimeric oncogene called breakpoint cluster region-abelson (BCR-ABL) whose protein product has tyrosine kinase activity, causes uncontrolled proliferation of the myeloid cells. Although, imatinib, the first-generation tyrosine kinase inhibitor (TKI) achieved an extremely high response rate, some patients developed resistance to it. Thus, second-generation TKIs such as nilotinib, dasatinib, bosutinib were developed which proved very useful, till the emergence of T315I point mutation which occurs in the BCR-ABL gene and renders CML resistant to previous TKIs. Ponatinib, a third generation TKI approved by the United States Food and Drug Administration (FDA), showed great promise as it was effective even against T315I point mutation. However, a recent increase in the incidence of blood clots observed in patients taking ponatinib has resulted in FDA temporarily suspending all trials, marketing and distribution of the drug. Hence, whether ponatinib evolves as a miracle or disaster for the patients of CML is yet to be answered.
ABSTRACT
he study assessed 54 advertisements of 145 different drugs, published over one year (from December 2011 to November 2012) in an Indian medical journal, circulated widely mainly among general practitioners (GPs). The ethical guidelines of the World Health Organization (WHO) and Organisation of Pharmaceutical Producers of India (OPPI) for medicinal drug promotion were applied. The brand name was mentioned in all advertisements (100% compliance both with the WHO and OPPI criteria) and the names of the active ingredients were also mentioned in 128 (90.14%) advertisements. However, major adverse drug reactions were mentioned in only two advertisements (1.37%); precautions, contraindications and warnings in only two (1.37%); and major interactions in only one (0.68%). Only three advertisements (2.06%) were well substantiated with references. To ensure the ethical promotionof drugs among GPs, journals must introduce compulsory review and appraisal of promotional advertisements by a dedicated review board, including at least one member trained in pharmacology and one representative from the medical division of a pharmaceutical company.