Natrecor Dear Doctor Letters

Letters from Scios May 2005 and July 2005

On May 6, 2005, Scios and the FDA notified health care professionals of revisions to the Adverse Reactions/Effect on Mortality section of the prescribing information for Natrecor in an April Dear Doctor letter, which also provided information from Scios on several published reports that raise the question of whether Natrecor may have adverse effects on survival and kidney function.

Natrecor, or nesiritide, is used for patients who have severe congestive heart failure that has recently become worse. Natrecor is for patients who are short of breath while at rest or with minimal activity, a condition known as dyspnea, and it is typically administered to inpatients while the hospital.

On July 13, 2005, a second Dear Doctor letter was issued to advise health care professionals that the use of Natrecor should be strictly limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest. This July Dear Doctor letter stated expressly that Natrecor was not intended for off-label uses such as:

• Intermittent outpatient infusion
• Scheduled repetitive use
• To improve renal function
• To enhance diuresis

The FDA also compelled Scios to undertake a pro-active educational program to inform physicians regarding the conditions and circumstances in which Natrecor should and should not be used, and to ensure that current and future marketing and sales activities related to Natrecor are consistent with this educational program.

More commentary and analysis on Tom Lamb's Drug-Injury web log

• Read more about Natrecor label revision in April 2005
• Read more about July 2005 Dear Doctor Letter
• Read more on our Natrecor Information Page >>