NatrECOR - WARNING OF UNAPPROVED USE

May 17 , 2005: The New York Times reported that Natrecor was being agressively marketed for outpatient settings as a "tune-up" - uses not approved by the FDA. Reports have indicated that patients receiving Natrecor on a regular basis may experience adverse effects such as low blood pressure, kidney damage and death.

What you should know:

Natrecor, also known as Nesiritide, was approved by the FDA in 2001 for a type of acute congestive heart failure accompanied by shortness of breath. The manufacturer of the drug is a Fremont biotechnology firm Scios Inc., a unit of Johnson & Johnson. Natrecor's use was restricted to only be given in emergency settings and only to the sickest patients. Natrecor costs approximately $500 per dose, in comparison to the $10 per dose for similar drugs such as nitroglycerin or nitroprusside. In recent years, some physicians have given Natrecor on a regular basis to heart failure patients who weren't suffering from serious breathing problems.

In the July 14 edition of the New England Journal of Medicine, Dr. Eric Topol of the Cleveland Clinic alleged that Scios was aggressively marketing Natrecor for outpatient settings. Scios showed doctors how to bill Medicare for the off-label treatments, including a published 46-page billing guide and even providing an 800 number for billing help. Physicians can legally prescribe off-label use, but FDA regulations forbid drug companies from promoting such uses.

What can I do?

If you purchased Natrecor (on an out patient basis) you may have a right to a refund for the funds you paid. Additionally, if you have experienced any adverse effects from your use of Natrecor, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact our firm directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective pharmaceutical drug cases and we welcome any questions you may have.