Current Status of Angiotensin Receptor Blocker Recalls.

Area of Science:

• Pharmaceutical Science
• Drug Safety
• Regulatory Science

Background:

• Losartan was a top-prescribed drug in 2016, with many Angiotensin-II Receptor Blockers (ARBs) widely used.
• Since July 2018, numerous ARB products were recalled due to carcinogenic nitrosamine impurities.
• Drug recalls in the U.S. have been voluntary.

Purpose of the Study:

• To categorize marketed Angiotensin-II Receptor Blocker (ARB) products based on nitrosamine impurity presence.
• To provide clarity for clinicians regarding ARB product safety amidst ongoing recalls.

Main Methods:

• Data categorization by the Food and Drug Administration (FDA) in April 2019.
• Classification of ARB products into three groups: not present, to be determined (TBD), and to be determined with prior lot removals (TBD*).
• Analysis of complex data structured into hundreds of product rows.

Main Results:

• Despite recalls initiated in 2018, understanding ARB product impurity status remained challenging for clinicians over a year later.
• The FDA's categorization aimed to simplify the assessment of ARB products concerning nitrosamine contamination.
• Complexity in data presentation hindered immediate comprehension of which ARB products were safe.

Conclusions:

• Clinicians face ongoing difficulties in identifying impurity-free Angiotensin-II Receptor Blocker (ARB) products.
• Clearer, more accessible data presentation is needed to support informed clinical decisions regarding ARB use.
• Ensuring patient safety requires a streamlined understanding of drug purity following recalls.