Originally published July 18 2005
Heart failure drug designed for blacks may cause lupus in black women
by Mike Adams, the Health Ranger, NaturalNews Editor
A new heart-failure drug specifically designed for use in black patients contains an ingredient that can increase black women's risk of developing lupus, an immune system disorder that already disproportionately affects black females.
BiDil was officially launched yesterday by NitroMed of Lexington, Mass., 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, long has been known to cause lupus in some patients, according to FDA documents and interviews with doctors.
Heart-failure death rates for black women are nearly twice as high as for white women.
Several cardiologists and lupus specialists agree that the benefits of BiDil appear to clearly outweigh its risks, since heart failure is much more serious than lupus.
But some question 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.
Dr. Daniel Wallace, a lupus specialist at Cedars-Sinai Medical Center in Los Angeles, said it could backfire on patients who conscientiously take the BiDil but tend to shrug off joint pains, fever and other flulike symptoms that could indicate lupus.
A blood test for lupus antibodies costs about $30, he said.
Doctors should tell patients in advance of the lupus risk, said Wallace, adding, "it's probably good medicine to be tested twice a year."
Indeed, regular testing is recommended in FDA-approved prescribing information for the generic form of hydralazine.
It says patients taking the generic should be tested for lupus antibodies before starting on the drug, and "periodically" thereafter.
The prescribing information, also known as the drug "label," guides doctors on how to use a medication and prevent unwanted side effects.
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