Heart failure steals precious moments away.

BiDil is the first heart failure (HF) treatment specifically for African Americans

BiDil has been approved by the US Food and Drug Administration (FDA) for use by self-identified African American patients in addition to routine HF medicines.

In a large clinical study called the African American Heart Failure Trial (A-HeFT), a group of African American patients with HF took BiDil along with their usual HF medicines. A similar group of patients took only their usual medicines. The study found that BiDil users had a 43% better survival rate during the course of the study and were 39% less likely to need hospitalization for HF. The BiDil group also reported a significant improvement in their day-to-day functioning. Results from the trial were so compelling that the trial was stopped early due to the significant survival benefit seen with BiDil. The FDA based the approval of BiDil primarily on the results from A-HeFT.1

A-HeFT was the first clinical trial to specifically study African American men and women with HF. Most patients in the clinical study of BiDil received routine HF medicines.1

Once you know about BiDil, you can talk with your doctor to see if BiDil may be right for you.

Please click here to see full Prescribing Information for BiDil.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

Information for Patients about BiDil® (isosorbide dinitrate/hydralazine HCl)

BiDil is approved for use with other heart medicines to treat heart failure in black patients to improve survival, improve heart failure symptoms, and help patients stay out of the hospital longer. There is little experience in patients with heart failure who experience significant symptoms while at rest. Most patients in the clinical study of BiDil also received other heart failure medicines.

IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

WARNINGS AND PRECAUTIONS

Also tell your doctor if you are taking any medication to decrease blood pressure because when taken with BiDil, blood pressure may become too low.

It is possible you'll get headaches, especially at first, but they often lessen over time. Keep your doctor posted on your headache progress; he or she may want to adjust your dosage.

If you experience dizziness, call your doctor. Please make sure to tell your doctor about any of the signs or symptoms mentioned below or about any unusual events that worry you.

Drinking less fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.

Lightheadedness may occur when standing, especially after sitting or lying down.

If you experience any achy and/or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night's sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.

You may also experience rapid heartbeat that could lead to chest pain or aggravate chest pain, or numbness or tingling in the hands or feet.

COMMON SIDE EFFECTS

Headache and dizziness were the most frequent side effects experienced in studies with BiDil.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here to see full Prescribing Information for BiDil. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Ask your doctor if BiDil may be right for you.

Reference: 1. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351(20):2049-2057.