BiDil safety and tolerability

The most common adverse events with an incidence ≥2% higher with BiDil than placebo in the African American Heart Failure Trial (A-HeFT) were1

Headache

  • 50% of patients taking BiDil reported headaches compared with 21% taking placebo
  • 7% of the active drug arm stopped study medication because of headaches
  • Patients should be told that headaches often accompany treatment with BiDil, especially during initiation of treatment
    • Headaches tend to subside with continued dosing

Dizziness

  • 32% of patients taking BiDil reported dizziness compared with 14% taking placebo

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.

Adverse events occuring in the A-HeFT study in ≥2% of patients treated with BiDil1

BiDil
(N=517)
Placebo
(N=527)
Headache50%21%
Dizziness32%14%
Asthenia14%11%
Nausea10%6%
Hypotension8%4%
Sinusitis4%2%
Ventricular
Tachycardia
4%2%
Paresthesia4%2%
Vomiting4%2%
Amblyopia3%1%

In A-HeFT, 21% of patients discontinued BiDil due to adverse reactions compared with 12% of patients who discontinued placebo.1


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.

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IMPORTANT SAFETY INFORMATION

BiDil is contraindicated in patients who are allergic to organic nitrates, or who take a phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.

INDICATIONS AND USAGE

BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

IMPORTANT SAFETY INFORMATION

BiDil is contraindicated in patients who are allergic to organic nitrates, or who take a phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.

WARNINGS AND PRECAUTIONS

Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome. Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.

Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. Hypotension is most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of BiDil. Hydralazine hydrochloride can cause tachycardia and hypotension potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy.

Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop.

ADVERSE REACTIONS

Most common adverse reactions (> 5% more on BiDil than on placebo) were headache and dizziness.

The full Prescribing Information for BiDil is available here.

Reference: 1. BiDil [package insert]. Atlanta, GA: Arbor Pharmaceuticals, Inc; 2015.