ADVERSE REACTIONS
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
BiDil has been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received BiDil for at least 6 months, and 220 received BiDil for at least 12 months. In A-HeFT, 21% of the patients discontinued BiDil for adverse reactions compared to 12% who discontinued placebo. Overall, adverse reactions were more common in BiDil -treated than in placebo-treated patients. Table 1 lists adverse reactions reported with an incidence, after rounding, ≥ 2% higher on BiDil than on placebo in A-HeFT, regardless of causality. The most common reasons for discontinuing BiDil in the A-HeFT trial was headache (7%).
Table 1. Adverse Reactions Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with BiDil.
|
BiDil
(N=517)
% |
Placebo
(N=527)
% |
| Headache |
50 |
21 |
| Dizziness |
32 |
14 |
| Asthenia |
14 |
11 |
| Nausea |
10 |
6 |
| Hypotension |
8 |
4 |
| Sinusitis |
4 |
2 |
| Ventricular tachycardia |
4 |
2 |
| Paresthesia |
4 |
2 |
| Vomiting |
4 |
2 |
| Amblyopia |
3 |
1 |
In the V-HeFT I and II clinical studies, a total of 587 patients with heart failure were treated with the combination of isosorbide dinitrate and hydralazine hydrochloride. The type, pattern, frequency and severity of adverse reactions reported in these studies were similar to those reported in A-HeFT, described above and no unusual adverse reactions were reported.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of BiDil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Use of BiDil: The following adverse reactions have been identified with use of BiDil.
-
Cardiac Disorders: Palpitations
-
Ear and labyrinth disorders: Tinnitus, vertigo
-
Eye Disorders: Eyelid edema, vision blurred
-
Gastrointestinal Disorders: Abdominal discomfort, constipation
-
General Disorders and Administration Site Conditions: Facial pain, flushing, chest discomfort, chest pain, peripheral edema
-
Musculoskeletal and Connective Tissue Disorders: Pain in extremity, myalgia
-
Nervous Disorders: Dysgeusia, hypoaesthesia, migraine, syncope
-
Renal and Urinary Disorders: Chromaturia, pulmonary renal syndrome
-
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea
-
Reproductive System and Breast Disorders: Erectile dysfunction
-
Skin and Subcutaneous Tissue Disorders: Erythema, hyperhidrosis, pruritus, face swelling
Use of Hydralazine Hydrochloride or Isosorbide Dinitrate: The following reactions have been reported with use of either hydralazine hydrochloride or isosorbide dinitrate.
-
Blood and Lymphatic System Disorders: Blood dyscrasias, agranulocytosis, purpura, eosinophilia, splenomegaly.
-
Eye Disorders: Lacrimation, conjunctivitis.
-
Gastrointestinal Disorders: Paralytic ileus.
-
Hepatobiliary Disorders: Hepatitis.
-
Psychiatric Disorders: Psychotic reactions, disorientation.
-
Renal and Urinary Disorders: Difficulty in urination.
|
REPORTS OF SUSPECTED BIDIL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Bidil. The information is not vetted and should not be considered as verified clinical evidence.
Possible Bidil side effects / adverse reactions in 76 year old female
Reported by a consumer/non-health professional from United States on 2011-12-02
Patient: 76 year old female weighing 68.0 kg (149.7 pounds)
Reactions: Dizziness, Vision Blurred, Fall
Adverse event resulted in: hospitalization
Suspect drug(s):
Bidil
|
