Abstract

Minority patients taking prescription drugs for diabetes mellitus and hypertension are sick and vulnerable. They should not be subjected to poor quality medications that can make them worse. The purpose of this review is to present data fortifying an argument that Covid-19 will continue to disproportionally effect minorities who suffer with Type 2 Diabetes Mellitus, Hypertension, and GI ulcer disease by limiting drug safety for pharmaceuticals that are imported from oversea manufacturers even after the pandemic is over. As a foundation an overview of the Food and Drug Administration (FDA) overseas inspection process that have been validated by previously published reports will be offered to accent the procedural process. Limitations and challenges to the overseas drug inspection process as documented by congressional leadership and the FDA are offered. An accurate scientific description of N-nitrosodimethylamine (NDMA) will be presented to emphasize its danger to these patients. Five key points or initiatives recently published by the FDA to assist in food and drug safety from overseas manufacturers during the Covid-19 pandemic will be presented

Highlights

  • The effects of COVID-19 on the health of racial and ethnic minority groups is still being studied

  • The purpose of this review is to present data fortifying an argument that Covid-19 will continue to disproportionally effect minorities who suffer with Type 2 Diabetes Mellitus, Hypertension, and GI ulcer disease by limiting drug safety for pharmaceuticals that are imported from oversea manufacturers even after the pandemic is over

  • An attractive inference can be made that a clinician would utilize metformin, angiotensin II receptor blockers (ARBs), and H2 antagonists to treat these chronic conditions in a patient diagnosed with Type 2 diabetes mellitus

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Summary

Introduction

The effects of COVID-19 on the health of racial and ethnic minority groups is still being studied. [4] Ethnic minority populations in the United States are disproportionately affected by cardiovascular disease (CVD) risk factors, including hypertension, overweight/obesity, and Auctores Publishing – Volume 3(1)-008 www.auctoresonline.org diabetes.[4,5] An attractive inference can be made that a clinician would utilize metformin, angiotensin II receptor blockers (ARBs), and H2 antagonists to treat these chronic conditions in a patient diagnosed with Type 2 diabetes mellitus Given, this inference and the reality that N-nitrosodimethylamine (NDMA) has been detected in toxic levels by the Food and Drug Administration (FDA) in these pharmaceuticals allows for a concern to be voiced that these patients may be exposed to this carcinogen. Unacceptable levels of this potentially carcinogenic impurity have been identified in products manufactured by 5 different firms that the FDA is working with these manufacturers to begin recalls. [18,19] Lastly, not present in samples of the plain metformin active, elevated levels of NDMA Have been found in finished-dose tablets of the Metformin ER formulation. [18, 19]

Key points regarding Foreign Drug Inspections
Findings
Conclusions

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