J Postgrad Med
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Review
Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?
Biosimilars are being marketed in India since 2000. Like biologics, biosimilars have a large size, complex structure, and complicated manufacturing process, and they are produced in a living organism. It requires specialized delivery devices for administration and needs tighter temperature control to prevent degradation. ⋯ However, biologics require tighter monitoring to ensure their safety and efficacy. This review article discusses the importance of pharmacovigilance for biosimilars, how it is different from generics, and provides recommendations to sensitize clinicians and researchers about the requirement of a different approach to improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is as important as it is for innovator biologics and more important than that for generics.
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Globally, around half of all under-5 deaths are attributable to undernutrition. The magnitude of child undernutrition in India is one of the highest in the world. Responsive feeding that has the potential to optimize nutrition and development depends on a "healthy mother". ⋯ Burden of maternal depression is high among mothers of infants who attended immunization clinic in a rural medical college in central India and is significantly associated with nonresponsive feeding practices.
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Dipeptidyl peptidase-4 inhibitors (DPP-4i) are one of the mainstay drugs in the management of type 2 diabetes mellitus. It has been well-documented that these class of drugs cause allergic reactions. ⋯ Here, we report a case of probable DPP-4i-induced BP in an elderly man, which resolved on discontinuation of the drug. Although this adverse drug reaction has been documented in Western world and Japanese ethnicity, this seems to be the first case report of such occurrence in Indian ethnicity.
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Gastroesophageal reflux disease (GERD) is one of the common gastrointestinal disorders worldwide. Recent epidemiologic studies have suggested that use of statins may lower the risk of GERD although the results from different studies were inconsistent. This systematic review and meta-analysis were conducted with the aim to summarize all available data. ⋯ The current meta-analysis found that the risk of GERD was numerically lower among statin users although the pooled result did not reach statistical significance. Therefore, more studies are still needed to further clarify this potential benefit of statins.