In May 2005 Scios Sent a Natrecor "Dear Doctor" Letter to Heart Doctors

Natrecor is a prescription drug approved by the FDA as a therapy for hospitalized patients or those rushed to emergency rooms in acute heart failure.  The FDA approved Natrecor, also known as nesiritide, in 2001.  Natrecor is at the center of some current controversy, however, because the Natrecor increasingly is being given to outpatients; it is these "off-label" Natrecor treatments that critics say may be dangerous to patients.

The doctors who are critics generally say Natrecor should be used with caution; significantly, they are not calling for the withdrawal of Natrecor from the market. First, the doctors point out that Natrecor can cause serious side effects in hospitalized patients.  Second, and perhaps more the reason for concern, it may prove that Natrecor side effects are even more problematic in patients who are receiving the cardiac drug on a regular, repeated schedule as an outpatient. Notably, Natrecor was not approved by the FDA to be administered to outpatients multiple times per week.

Dr. Jonathan Sackner-Bernstein, director of clinical research at North Shore University Hospital in Manhasset, and chief investigator of two key studies on the Natrecor side effect problems, has recently maintained that Natrecor is a drug that should be used "as a last resort", and not repeatedly.

Natrecor’s maker, Scios Inc., a division of Johnson & Johnson, say Natrecor is a drug that is safe and effective when used according to its label. In the first part of May 2005,  Scios sent a Natrecor "Dear Doctor" letter to health heart specialists nationwide, underlining mortality risks which have been associated with Natrecor use.

As for Natrecor’s increasing regular, repeated use in outpatient clinics, Johnson & Johnson said the Natrecor package label insert does not say that Natrecor should not be administered on a repeated, outpatient basis.  Moreover, Johnson & Johnson has asserted that it cannot control how doctors prescribe Natrecor to their patients.  The FDA takes the position that doctors are free to prescribe any approved medication "off-label."

• Read more about drug-safety issues regarding Natrecor

http://www.drug-injury.com/druginjurycom/2005/05/may_19_fda_anno.html

(Posted by: Tom Lamb)