BiDil, called heart-drug for blacks, approved by FDA

The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a drug for the treatment of heart failure in self-identified black patients. FDA called it “a step toward the promise of personalized medicine.” It is the first medication on the market for a specific racial group.

Some medical experts see a downside to approving medicine for specific races, notices AP.

Dr. David Magnus, director of the Stanford Medical Center for biomedical ethics, told AP, that "there are many, many who claim these use of (racial) categories may not have any biological meaning, only social meaning, and basing medical decisions on them may be problematic."

“The more we know genetically, the more we know these social categories don't correspond to genetic groups," Magnus said. In the case of BiDil, officials at the Food and Drug Administration said a study of 1,050 black patients with severe heart failure was convincing. The study showed a 43 percent reduction in deaths and a 39 percent decrease in hospitalizations compared with a placebo.

Dr. Robert Temple, the FDA's associate director of medical policy, "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".

The National Medical Association (NMA), an organization that promotes the interests of black physicians and patients in eliminating health disparities, praised the FDA's decision.

According to U.S. Newswire, Dr. Winston Price, president of the NMA commended the FDA for approving BiDil as a new drug for reducing the burden of heart disease in America.

"The FDA has given recognition to a life-saving drug to help stem the unacceptable tide of African Americans continuing to die from heart disease at the alarming rate of about 78,000 every year," Dr. Price stated.

In fact, writes Palm Beach Post, BiDil did not start out as "a drug for blacks." Neither does BiDil give blacks a license to overindulge in high-salt diets, fried and fatty foods, smoking or other behaviors — even those born out of poverty — that, if avoided, could help prevent heart disease in the first place.

According to FDA official information, BiDil is a combination of two older drugs, neither approved for heart failure - hydralazine and isosorbide dinitrate.

As an anti-hypertensive agent, hydralazine relaxes the arteries, and decreases the work of the heart. The anti-anginal agent, isosorbide dinitrate, relaxes the veins as well as the arteries. Isosorbide seems to work by releasing nitric oxide at the blood vessel wall, but its effect usually wears off after half a day. Hydralazine may prevent this loss of effect. But how the two drugs work together is not fully known.

Some common side effects with the use of BiDil are headache and dizziness.

The American Heart Association ranked BiDil second among last year's top 10 major gains in heart disease and stroke research. The president of the International Society of Hypertension in Blacks called it "the most important advance in the treatment of black people" that he has seen in his lifetime. An FDA advisory panel last week unanimously recommended approval in what the chairman called a "precedent-setting" case, reports Palm Beach Post.

BiDil is marketed by NitroMed, Inc. of Lexington, MA.

More on treating heart disease you can read here.