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The Debate Over BiDil: Does Race-Based Marketing Have a Place in Modern Medicine?

Zuri C. Hawkins-Jarrett, PharmD, MPH, BCPSKarla Robinson, MD
Updated on May 19, 2023

Key takeaways:

  • BiDil (isosorbide dinitrate/hydralazine) is the first FDA-approved medication for a single racial group — Black adults with heart failure. As of 2022, a lower-cost generic option is also now available. 

  • BiDil’s approval started a conversation about considering race in treatment decisions. Other examples of race-based applications in medicine include heart failure risk scores, kidney function tests, and certain pregnancy-related tools.

  • BiDil is still recommended for Black adults with advanced heart failure. But it’s usually added if you’re still experiencing symptoms with first-choice treatments.

02:12
Featuring Pilar Stevens-Haynes, MD, Marrick Kukin, MD
Reviewed by Sarah Gupta, MD | February 5, 2025

Over the last few decades, advancements in genetic research and personalized medicine have led to targeted treatments for various health conditions. However, the use of race in determining medical treatments has stirred controversy and ethical debates.

The first medication approved for a specific race was BiDil — a combination pill marketed for Black people with heart failure. And while BiDil may have a proven benefit in this population, only a small percentage of eligible people are taking it.

With hospitalization and death from heart failure still on the rise in Black adults, where does BiDil fit into the picture? Below we explore BiDil and other race-based strategies in medicine, and how they may influence care.

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What is BiDil?

BiDil is an oral medication that’s a combination of two generic drugs — isosorbide dinitrate and hydralazine. These drugs have been used separately for many years to treat high blood pressure and chest pain. But they had never been in the same pill together for heart failure until BiDil was approved.

Isosorbide dinitrate acts on both your arteries and veins by causing your body to release nitric oxide, which is key for relaxing your blood vessels. Hydralazine primarily works on your arteries but also helps keep nitric oxide around in your body longer.

BiDil and its generic are currently available as a tablet containing 20 mg of isosorbide dinitrate with 37.5 mg of hydralazine. You’ll typically take 1 to 2 tablets 3 times daily.

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History of BiDil’s approval

BiDil’s approval in 2005 sparked controversy about drugs approved for specific populations. But this wasn’t originally the intention.

BiDil was first submitted for approval in 1997, but it was rejected. The FDA didn't feel the evidence from clinical trials supported its use as a treatment for heart failure. Participants in these clinical trials were over 70% white.

However, researchers re-examined the data on advice from the FDA. They found that Black participants with advanced heart failure appeared to benefit from BiDil. These results led to the African-American Heart Failure trial.

A-HeFT (African-American Heart Failure Trial)

In the A-HeFT trial, participants who self-identified as Black or African American were divided into two groups. One group got the placebo (a dummy pill) and the other got a fixed-dose combination of isosorbide dinitrate and hydralazine (BiDil).

The results showed that BiDil, when taken with other heart failure medications, could lower death by over 40%. Hospitalizations for heart failure were also significantly less in the BiDil group. This was compared to a placebo group that did not receive the medication. In fact, researchers stopped the trial early after seeing a higher death rate in the placebo group.

This is why BiDil was ultimately approved, but only for self-identified Black adults with heart failure. However, there were many critics of the FDA’s decision to approve a medication for a specific racial group — especially since there’s no biological basis for race. There’s also incredible genetic diversity among people who identify as Black.

Even so, the FDA still says that the positive effects of BiDil in self-identified Black people are too great to be ignored. And, the medication doesn’t appear to help other people in the same way.

Other cases of race-based medicine

After BiDil’s approval, questions on race-based prescribing practices emerged. And many healthcare providers can’t agree on whether race plays a major role in deciding on appropriate treatment options.

Since a person’s race can be subjective, this doesn’t always lead to a similar genetic profile for any one race. What’s more, some argue that treatment plans based on race may affect health outcomes. Below are a few examples:

Specialty

Assessment tool

Description of tool 

Cardiology 

Heart failure (HF) risk score 

This score predicts a person’s risk of death due to a HF hospitalization. Being “Nonblack” gives someone higher point values, increasing the likelihood they would be referred to a specialist for a higher level of care.

Nephrology

Estimated glomerular filtration rate (eGFR) or rate of kidney function

An equation used to calculate a person’s level of kidney function. Higher eGFR rates are equated with better kidney function. Black patients’ scores are often higher due to a correction factor used. This possibly delays a referral to a specialist or the need for a transplant.

Obstetrics 

Vaginal Birth after Cesarean (VBAC) algorithm

This algorithm estimates a woman’s risk of having a child vaginally after a C-section. Black and Hispanic women often receive low chances of success and may not be offered the option to have a VBAC. Women who have successful VBACs typically have better health outcomes. Race has since been removed from the calculation.

Urology

STONE score or likelihood of having a kidney stone

This scoring system is often used in the emergency room to figure out a person’s chance of having a kidney stone. A higher point value is given to those considered “Nonblack.” Higher scores could mean further evaluation for a stone and more intense care.

In each of these examples, lower scores or risk based on a person’s race could delay care. Often, the evidence backing these assessment tools couldn't explain how race affected scoring. This highlights why recognizing factors besides race is important in determining treatment options.

Does BiDil still have a place in therapy?

Despite initial evidence for using BiDil in Black adults with heart failure, studies show it’s not used very often.

Heart failure treatment guidelines still recommend BiDil for Black adults with advanced disease. But, it’s typically considered if you’re still experiencing symptoms after optimizing first-choice medications.

Prior to 2022, BiDil was only available as a brand-name medication. This may have created an additional barrier to accessing the medication. Today, you can save over 70% off the average retail price of generic BiDil with a free GoodRx discount.

The bottom line

The conversations around race-based treatment decisions sparked by BiDil continue today. Healthcare providers agree individualizing patient care is essential. However, basing it solely on race can prove detrimental. Speak with your healthcare provider if you have concerns about your treatment options and how your race may affect those decisions.

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Why trust our experts?

Zuri C. Hawkins-Jarrett, PharmD, MPH, BCPS
Zuri Hawkins-Jarrett graduated with her doctorate in pharmacy from The University of Georgia College of Pharmacy. She completed her residency training with Piedmont Columbus Regional in ambulatory care.
Alyssa Billingsley, PharmD
Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.
Karla Robinson, MD
Reviewed by:
Karla Robinson, MD
Karla Robinson, MD, is a medical editor for GoodRx. She is a licensed, board-certified family physician with almost 20 years of experience in health through varied clinical, administrative, and educational roles.

References

Cohn, J. N., et al. (1991). A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. The New England Journal of Medicine. 

Cole, R. T., et al. (2011). Hydralazine and isosorbide dinitrate in heart failure. Circulation. 

View All References (12)

Duello, T. M., et al. (2021). Race and genetics versus ‘race’ in genetics. Evolution, Medicine, & Public Health. 

Heidenreich, P. A., et al. (2022). 2022 AHA/ACC/HFSA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 

Jørgensen, J. T. (2019). Twenty years with personalized medicine: Past, present, and future of individualized pharmacotherapy. The Oncologist. 

Krimsky, S. (2012). The short life of a race drug. The Lancet. 

Lewsey, S. C., et al. (2021). Racial and ethnic disparities in heart failure: Current state and future directions. Current Opinion in Cardiology. 

Maglo, K N., et al. (2015). BiDil in the clinic: An interdisciplinary investigation of physicians’ prescription patterns of a race-based therapy. American Journal of Empirical Bioethics. 

National Kidney Foundation. (n.d.). Understanding African American and non-African American eGFR laboratory results

RICONPHARMA LLC. (2022). ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE [package insert]

Rubashkin, N. (2022). Why equitable access to vaginal birth requires abolition of race-based medicine. AMA Journal of Ethics. 

Taylor, A. L., et al. (2004). Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. The New England Journal of Medicine. 

Temple, R., et al. (2007). BiDil for heart failure in Black patients: The U.S. Food and Drug Administration perspective. Annals of Internal Medicine. 

Vyas, D. A., et al. (2020). Hidden in plain sight– Reconsidering the use of race correction in clinical algorithms. The New England Journal of Medicine. 

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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