Obladi oblada-Life goes on

Thursday, June 23, 2005

Pharm students might find this interesting or maybe not :-)

WASHINGTON (AP) -- The heart failure drug BiDil was approved Thursday by government regulators for use by blacks. It will be the first medication marketed for a specific racial group.

The Food and Drug Administration called the approval a step toward "the promise of personalized medicine."

Studies showed that blacks benefited from the drug while the general population did not.

The drug is marketed by NitroMed Inc. of Lexington, Massachusetts.

"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, the agency's associate director of medical policy. "In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil."

A study indicated that the drug led to a 43 percent reduction in deaths from heart failure among the blacks who took it. Research was stopped early after scientists realized the benefits of the drug so the data could be presented for the drug's approval.

BiDil is a combination of two older drugs, hydralazine and isosorbide dinitrate, neither approved for heart failure. Some common side effects with the drug are headache and dizziness.


I can't believe I actually understand why this drug causes headache and dizziness. I wonder if they have found any drug-induced lupus in the trials.

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