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AUDIO: Dr. Underwood: FDA Reviews Heart Research on Minorities & Some Drugs Not Effective on Minorities

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EmpowHer Asks: If heart disease effects ethnicities differently, does the FDA -- the Food and Drug Administration -- encourage drug companies to present data across all of the demographic groups?

 


 

Dr. Paul Underwood: Yes, the FDA is strongly considering or encouraging drug companies to present data as it relates to different genders, men and women, ethnicities and age as well. And so there is a strong push by the FDA to make sure that the studies that are done can be generalized over wide population ranges. So that if medicine is approved than it may be useful for Asians as well, so we have to know the effectiveness of the agent in that group as well as any potential side effects because sometimes side effects are more common in certain groups than other groups. An example is with the angiotensin-converting enzyme inhibitors, which are remarkable medications, which protect the kidneys, protect the blood vessels, protect the heart and can actually reduce stroke.

So they are very useful medications and we use them where we like to use them on people because they do such good things. Yet some groups have higher side effects particularly cough, which is a major side effect of it.

And so perhaps Asians and African-Americans seem to have higher incidence of cough on using these agents even though they are very effective, they are just a higher risk of side effect. And we have to be aware of that when we are using these medicines because if we identify patients who have that side effect we need to make adjustments in the therapy.

Paul L. Underwood Jr., M.D., is an interventional cardiologist in Phoenix, was the 10th president of the Atlanta-based Association of Black Cardiologists 2004-2006 (ABC), Inc.