ADVERSE REACTIONS
Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions.
Adverse Reactions Which Were Volunteered or Elicited(and at least possibly drug related) Body System/
Adverse Reactions | Visken ®
(pindolol)
(N=322)
% | Active
Controls*
(N=188)
% | Placebo
(N=78)
% |
|
|
|
|
| Central Nervous System |
|
|
|
| Bizarre or Many Dreams | 5 | 0 | 6 |
| Dizziness | 9 | 11 | 1 |
| Fatigue | 8 | 4 | 4 |
| Hallucinations | <1 | 0 | 0 |
| Insomnia | 10 | 3 | 10 |
| Nervousness | 7 | 3 | 5 |
| Weakness | 4 | 2 | 1 |
| Autonomic Nervous System |
|
|
|
| Paresthesia | 3 | 1 | 6 |
| Cardiovascular |
|
|
|
| Dyspnea | 5 | 4 | 6 |
| Edema | 6 | 3 | 1 |
| Heart Failure | <1 | <1 | 0 |
| Palpitations | <1 | 1 | 0 |
| Musculoskeletal |
|
|
|
| Chest Pain | 3 | 1 | 3 |
| Joint Pain | 7 | 4 | 4 |
| Muscle Cramps | 3 | 1 | 0 |
| Muscle Pain | 10 | 9 | 8 |
| Gastrointestinal |
|
|
|
| Abdominal Discomfort | 4 | 4 | 5 |
| Nausea | 5 | 2 | 1 |
| Skin |
|
|
|
| Pruritus | 1 | <1 | 0 |
| Rash | <1 | <1 | 1 |
*Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.
POTENTIAL ADVERSE EFFECTS
In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Visken® (pindolol).
Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS)
Allergic: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.
Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.
Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.
Miscellaneous: Reversible alopecia; Peyronie’s disease.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Visken® (pindolol) during investigational use and extensive foreign experience amounting to over 4 million patient-years.
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