"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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)
| Active Controls*
|Central Nervous System|
|Bizarre or Many Dreams||5||0||6|
|Autonomic Nervous System|
|*Active Controls: Patients received either propranolol, a-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)
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.
Read the Visken (pindolol) Side Effects Center for a complete guide to possible side effects
Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients receiving Visken ® (pindolol) plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.
Visken ® (pindolol) has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.
Visken ® (pindolol) has been shown to increase serum thioridazine levels when both drugs are co-administered. Visken® (pindolol) levels may also be increased with this combination.
Risk of Anaphylactic Reaction
While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Read the Visken Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/13/2008
This monograph has been modified to include the generic and brand name in many instances.
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