Publication Date
8-1-2020
Journal
Cardiovascular Drugs and Therapy
DOI
10.1007/s10557-020-06976-0
PMID
32318933
PMCID
PMC7171054
PubMedCentral® Posted Date
4-21-2020
PubMedCentral® Full Text Version
Post-Print
Published Open-Access
yes
Keywords
Angiotensin II Type 1 Receptor Blockers, Carcinogens, Drug Approval, Drug Contamination, Drug Industry, Drug Recalls, Humans, Patient Safety, Quality Control, Risk Assessment, Risk Factors, United States, United States Food and Drug Administration
Abstract
PURPOSE: Beginning in July of 2018, the FDA issued a voluntary recall regarding the presence of a contaminant found in the manufacturing of valsartan. What would ensue has become a largely unprecedented sequence of alarming events since the FDA began reporting public recalls, withdrawals and safety alerts on their website in 2016. Since then, the United States has been significantly impacted by drug recalls affecting angiotensin receptor blockers. This report arms clinicians with additional guidance and provides a framework for responding appropriately to future similar incidents and includes an overview of the angiotensin receptor blockers, and their effects and safety profiles.
METHODS: This report includes a review of data from all pertinent clinical and scientific sources including information from the FDA's inspection documents and recall website. Additional information is provided on the specific bottles including all lot numbers, expiration dates, etc. RESULTS: The recalls/withdrawals are attributable to the presence of cancer-causing contaminants identified during the manufacturing process from drug manufacturers abroad. The root causes behind the recalls and subsequent shortage appear multifactorial, and stem to a certain extent from the outsourcing of medication manufacturing overseas and lack of quality checks and appropriate oversight.
CONCLUSIONS: This inherent issue is not likely to resolve soon and has eroded the public trust of/in the healthcare system and the pharmaceutical industry. Patients and healthcare providers are significantly affected and should have a full understanding of the matter in order to guide appropriate response and actions.
Comments
Associated Data