Reviewing drug package inserts available in United Arab Emirates for USFDA recommended pharmacogenomic information

Abstract

Anoop Kumar Agarwal, Mukesh Kumar and Shehnaz Syed Illyas

Pharmacogenomics aims to characterize the contribution of genetic polymorphisms to variability in therapeutic response and toxicity. The USFDA has issued a list of drugs which exhibit polymorphism and relevant sections in the package inserts for providing pharmacogenomic information and their biomarkers to reduce the risk of drug toxicity. A total of 67 Package inserts of 41 drugs in 5 therapeutic areas, available in UAE under various brand names, were thoroughly reviewed for direct and indirect pharmacogenomic information and compared with FDA recommendations. It was observed that only 26 package inserts of 17 drugs (41%) prescribed provided direct genetic evidence and information on the type of polymorphism influencing drug efficacy and toxicity. Indirect indicators describing genetic variation in metabolizing enzyme activity was present in 20 inserts (30%)., It was concluded that incorporating the necessary pharmacogenomic information, as recommended by the USFDA, in the package inserts of drugs available in UAE will help in enhancing drug efficacy, safety and awareness among the physicians, pharmacists and patients.

PDF