FDA Downplays Contaminated ARBs Exposure

CDER director Janet Woodcock says the actual risk to patients due to contaminants in angiotensin I receptor blockers (ARBs) is likely much lower than FDA estimates that reflect a scientific assessment of the highest possible exposure. In an online statement, she says stakeholders often ask how many patients have been affected by contaminated ARBs. While FDA knows the number of patients taking ARBs, she writes, it does not know how many have been affected by the recalls.

She lists a number of reasons why it is difficult for the agency to know how many people were affected, and concludes that it believes there were likely more drugs replaced due to recalls than necessary, which means more patients were affected but not necessarily exposed to an impurity.

The post discusses how FDA is enhancing oversight of manufacturing data and how its investigation into ARB contamination is expanding.