The Rise And Fall Of Natrecor For Congestive Heart Failure: Implications For Drug Policy

From Health Affairs.

By Jerry Avorn, MD.

SUMMARY: This Health Affairs article by Dr. Avorn uses the case of nesiritide (Natrecor) — a drug approved for acute decompensated heart failure that was rapidly adopted into widespread practice before post-market studies raised serious concerns about its safety and efficacy — to illuminate broader problems in the US drug approval and post-market surveillance system. The Natrecor story illustrates the risks of rapid clinical adoption of drugs approved on the basis of surrogate endpoints or short-term studies, without adequate evidence of long-term outcomes or comparative effectiveness. (Note: Full text paywalled; summary based on publicly available title, description, and field context.)

BACKGROUND: Nesiritide (Natrecor) was approved by the FDA for acute decompensated congestive heart failure and rapidly adopted by hospitals. Subsequent post-market research raised concerns about both its safety and its clinical benefit.

KEY FINDINGS: Not fully retrievable from publicly available text; article is paywalled. The piece examines how Natrecor's clinical rise and fall illustrates systemic weaknesses in drug approval and post-market surveillance.

IMPLICATIONS: The Natrecor case illustrates the risks of rapid widespread adoption of drugs approved on limited evidence, reinforcing the need for robust post-market safety and effectiveness studies and comparative effectiveness data.