Reflections of the Angiotensin Receptor Blocker Recall by the FDA and Repercussions on Healthcare

• Published in: Cardiovascular drugs and therapy 2020-08, Vol.34 (4), p.579-584
• Main Authors: Gillette, Michael, Taylor, Addison, Butulija, Djenita, Kadiyala, Himabindu, Jneid, Hani
• Format: Article
• Language: English
• Subjects: Angiotensin; Angiotensin II Type 1 Receptor Blockers - adverse effects; Angiotensin II Type 1 Receptor Blockers - analysis; Carcinogens - analysis; Cardiology; Contaminants; Drug Approval; Drug Contamination; Drug Industry - standards; Drug Recalls; Editorial; Health care; Humans; Industrial safety; Inspection; Manufacturing; Manufacturing industry; Medicine; Medicine & Public Health; Outsourcing; Patient Safety; Pharmaceutical industry; Product recalls; Quality Control; Receptors; Risk Assessment; Risk Factors; United States; United States Food and Drug Administration - standards; Websites
• ISSN: 0920-3206; 1573-7241
• DOI: 10.1007/s10557-020-06976-0

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.