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Home >> World
UPDATED: 15:34, June 24, 2005
FDA approves controversial heart failure drug for black patients
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The US Food and Drug Administration (FDA) on Thursday approved heart failure drug BiDil (bye-DILL) for the use by black people, a step it said "toward the promise of personalized medicine."

The drug is the first medication the FDA approved to target a specific racial group.

The approval was based in part on a study that showed black patients benefited from BiDil while the general population did not.

The study, which involved 1,050 black patients with severe heart failure, found the drug can reduce deaths among the patients by 43 percent, and reduce hospitalization for heart failure by 39 percent.

"The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition," said Dr. Robert Temple, FDA associate director of medical policy.

Heart failure is a condition in which the heart is weakened and unable to pump enough blood. It can be caused by a variety of damage to the heart, including heart attacks, high blood pressure, and infections.

BiDil is marketed by NitroMed Inc. of Lexington, Massachusetts. It is a combination of two older drugs, hydralazine and isosorbide dinitrate, neither approved for treating heart failure. Some common side effects with the drug are headache and dizziness.

Source: Xinhua


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