Bedaquiline: A Novel Diarylquinoline for Multidrug-Resistant Pulmonary Tuberculosis.

A new drug Bedaquiline, a diarylquinoline agent has been approved by the Food and Drug Administration for the treatment of pulmonary multidrug-resistant tuberculosis. It has been given approval for use along with the basic regimen with only conditional access through the National Program for tuberculosis in India. The major problem with existing antitubercular drugs used for the treatment of multi-drug resistant tuberculosis is antimicrobial resistance, less efficacy, and poor side effect profile. Bedaquiline might be a solution to these issues. Bedaquiline is a first of its class drug with a unique and specific mechanism of action. It inhibits mycobacterial adenosine triphosphate (ATP) synthase's proton pump. There are many randomized clinical trials and cohort studies that reported a higher culture conversion rate with bedaquiline treatment as compared to the control group. Many meta-analyses and systematic reviews have reported higher culture conversion rate, higher cure rate, and lower mortality rate in patients with drug-resistant tuberculosis treated with a bedaquiline-containing regimen. Here is a detailed drug profile of bedaquiline to help health care workers treat tuberculosis patients. Keywords.

Critical Appraisal of Drug Promotional Literature in Accordance With WHO Guidelines.

Background Drug promotional literature (DPL) is used as a marketing tactic to publicize the introduction of new medications. As drug companies are promoting the literature for their brand products, bias is possible. Various studies have demonstrated that printed DPLs disseminated by pharmaceutical companies are typically skewed. Material and method A prospective, observational study was carried out in the outpatient departments of a tertiary care hospital to analyze the DPL of different pharmaceutical companies using WHO criteria for "Ethical criteria for medicinal drug promotion, 1988". Results Out of 192 DPLs analyzed, information regarding the generic name, brand name, amount of active ingredient, and manufacturer name was found in all the DPLs (100%). Though therapeutic uses were mentioned in 91% of DPLs, dosage schedule (regimen) was mentioned only in 60%. Drug safety information such as the side effects and significant adverse drug reactions, precautions and warnings, contraindications, and major drug interactions were present in 24%, 36%, and 20%, respectively. Address of the manufacturer and reference to scientific literature were present only in 63% and 53% of DPLs, respectively. References mainly were from journals, present in 71% of DPLs. Most of the claims made in DPLs were regarding efficacy (73%), followed by safety (34%).  Conclusion In our study, not a single DPL fulfilled all the nine WHO criteria. A doctor should rigorously evaluate study findings before prescribing because misleading and incorrect information is now frequently found in this literature.