Heart drug for blacks has hazard

Compound in BiDil can lead to lupus, FDA and doctors say

July 02, 2005|By LOS ANGELES TIMES

WASHINGTON - An active ingredient in a new heart failure drug tailored for African-Americans can increase the risk of developing a form of lupus, a debilitating disease that strikes black women in disproportionately high numbers.

BiDil was officially launched yesterday by Massachusetts-based NitroMed, Inc. as the first drug intended for use by patients in a particular ethnic group. The Food and Drug Administration approved it June 23.

But one of its two key ingredients, a generic compound known as hydralazine hydrochloride, has long been known to cause lupus in some patients, according to FDA documents and interviews with doctors.

One in every 250 African American women has lupus, a painful immune system disorder. Black women are three times more likely to get lupus than white women. African-Americans are also more likely than whites to develop congestive heart failure, a weakening of the heart that impairs its ability to pump blood. Heart failure death rates for black women are nearly twice as high as for white women.

Several cardiologists and lupus specialists said that the benefits of BiDil appear to clearly outweigh its risks because heart failure is much more serious than lupus. But some of them questioned why FDA-approved prescribing information for BiDil fails to recommend that patients taking the drug get routine blood tests for lupus.

Such tests are recommended for patients taking the generic form of the ingredient in BiDil, hydralazine when it is prescribed separately.

"I would have rather the product [literature] say that people should have testing every six months," said Dr. Jonathan Sackner-Bernstein, a member of the FDA advisory panel that voted unanimously to recommend BiDil's approval.

An FDA spokeswoman said the agency stands by its decision. She suggested that decisions about testing are best left to individual doctors.

The Los Angeles Times is a Tribune Publishing newspaper.

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