Natrecor recall averted for the time being

Natrecor has been mired in controversy and the first step for a possible recall was taken yesterday at the Cleveland Clinic. As is well known, the Cleveland Clinic is among the top hospitals in the world and its cardiology department is among the best. It also has the unique distinction of having Dr. Eric Topol on its team, who is not only the best in his field, he has also contributed enormously towards ensuring drug safety in America by actively arguing for research and testing. He was instrumental in forcing a recall of Vioxx when he was pointing out the risks of Vioxx at a time that Merck was aggressively promoting the drug.

While a majority of the doctors at Cleveland Clinic want to ban Natrecor, the ad hoc committee of the Pharmacy and Therapeutics Committee took a slightly different view regarding the use of Natrecor for patients with congestive heart failure. The committee consists of a multi-disciplinary team of experts from pharmacy, pharmacology, cardiovascular medicine, critical care medicine, and drug information.

The meeting resulted in 8 recommendations including:

1. Natrecor will remain on the formulary at The Cleveland Clinic.
2. Natrecor will be used for decompensated congestive heart failure patients only.
3. Natrecor will be used in the FDA approved dose.
4. It should be used in accordance with the current FDA package insert.
5. Natrecor will be prescribed by the cardiovascular or critical care physicians.
6. Consistent with current policy, inpatients should be treated on appropriate inpatient floors within the hospital with training and education of support staff, including nurses.
7. The committee is aware that there will be an independent review and assessment of data associated with Natrecor chaired by Eugene Braunwald, M.D. of Harvard Medical School, in the near future and are awaiting their findings with interest.
8. The Cleveland Clinic will continue to gather and analyze data on the use of Natrecor.

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