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Pharmaceutical industry

Johnson & Johnson Updates Label for Heart-Failure Treatment Natrecor Amid Safety Concerns

Strategic Insights

— 1 min read

Natrecor, Johnson & Johnson's treatment for heart failure, has been revised to include data on deaths in its package insert. This change comes after studies published in medical journals raised concerns about an increased risk of fatal kidney problems in patients treated with the drug. The updated label reports that 5.3% of patients treated with Natrecor died, compared to 4.3% in control groups, but notes that the data may not be statistically significant due to small patient numbers. Despite its growing popularity, with expected sales reaching over $600 million this year, some doctors have questioned the use of Natrecor in outpatient clinics for patients with severe heart failure.

Key Takeaways:

  • Natrecor's label has been updated to include data on deaths, showing a 5.3% mortality rate in patients treated with the drug compared to 4.3% in control groups.
  • The updated label notes that the data may not be statistically significant due to small patient numbers.
  • Natrecor has been used in over 600,000 patients in the last four years and is growing in popularity, with expected sales reaching over $600 million this year.
  • Some doctors have questioned the use of Natrecor in outpatient clinics for patients with severe heart failure, citing its approved use for "acute" heart-failure patients.
  • Dr. Steven E. Nissen, a Cleveland Clinic cardiologist, has expressed concerns about the use of Natrecor in ambulatory settings, calling it "inappropriate and cannot be recommended".
  • Johnson & Johnson has hired Dr. Eugene Braunwald as an independent adviser on the drug to review all data on its safety.

Statistics:

  • 5.3% of patients treated with Natrecor died in clinical trials, compared to 4.3% in control groups.
  • 12.4% of patients treated with Natrecor (56 out of 1,059) died in the first 30 days, compared to 4.2% of control patients (28 out of 658).
  • 7.2% risk of death in 30 days was found in a study linking Natrecor to a higher risk of fatal kidney problems.
  • Natrecor has been used in over 600,000 patients in the last four years.
  • Expected sales of Natrecor may reach over $600 million this year.

Sources:

  • The New York Times: "Johnson & Johnson Adds Warnings to Its Heart Failure Drug"
  • Pink Sheet: "Natrecor Label Updated with Death Risk Information"
  • The Journal of the American Medical Association: "Cardiac hormone treatment for heart failure"
  • Circulation: "Natrecor and kidney impairment"

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