Betapace AF Side Effects

Please note - some side effects for Betapace AF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Betapace AF - for the Consumer

Betapace AF

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Betapace AF:

Dizziness; drowsiness; headache; lightheadedness; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormally fast, slow, or irregular heartbeat; changes in vision; decreased appetite; excessive thirst; numbness of an arm or leg; severe or persistent nausea, vomiting, or diarrhea; severe stomach pain; sharp or crushing chest pain; sudden leg pain; sudden severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; unusual sweating.

Betapace AF Side Effects - for the Professional

Betapace AF

Adverse events that are clearly related to Betapace AF are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects. The common documented beta-blocking adverse events (bradycardia, dyspnea, and fatigue) and Class III effects (QT interval prolongation) are dose related.

In a pooled clinical trial population consisting of four placebo-controlled studies with 275 patients with AFIB/AFL treated with 160-320 mg doses of Betapace AF, the following adverse events were reported at a rate of 2% or more in the 160-240 mg treated patients and greater than the rate in placebo patients. The data are presented by incidence of events in the Betapace AF and placebo groups by body system and daily dose. No significant irreversible non-cardiac end-organ toxicity was observed.

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse events leading to discontinuation of Betapace AF were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

In clinical trials involving 1292 patients with sustained VT/VF, the common adverse events (occurring in ≥2% of patients) were similar to those described for the AFIB/AFL population.

Occasional reports of elevated serum liver enzymes have occurred with sotalol therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.

In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m2 with dosing every 8 hours for a total of 9 doses, no Torsades de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m2 daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m2 daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTc ≥525 msec were seen in 2 patients at the 210 mg/m2 daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.

Potential Adverse Effects

Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction also include rare reports of: emotional liability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with Betapace AF during investigational use and foreign marketing experience.

Side Effects by Body System

Cardiovascular

Sotalol dosages should be reduced in patients with QTc intervals of 550 msec or greater, as the incidence of torsades de pointes is approximately 10% in such patients.

Limited animal data have shown that the incidence of potentially deleterious QT prolongation and associated risk of torsades de pointes can be significantly reduced with coadministration of mexiletine.

The SWORD (Survival with Oral d-Sotalol) trial was prematurely discontinued because the overall mortality of patients with a recent acute myocardial infarction and left ventricular systolic dysfunction who received sotalol was significantly greater than in those patients who received placebo.

Sotalol may significantly depress atrial inotropic activity after electrical cardioversion of atrial fibrillation.

Limited data have suggested that sotalol demonstrates "reverse use dependence", or a decreased effect of action potential prolongation at high (200 beat/min +) heart rates. Small in vivo studies in humans have not confirmed this potential lack of efficacy, but more data are needed.

Cardiovascular arrhythmias are the most serious side effects and are usually observed within one week of therapy initiation or dosage increases. Sotalol may prolong the QT interval in 5% of patients, and may induce arrhythmias, including torsades de pointes in 1% to 5% of patients. A proarrhythmic effect is more likely in female patients, in patients who present with sustained ventricular tachycardia or fibrillation, congestive heart failure, pre-existing QT prolongation, bradycardia, or hypokalemia, or patients who receive > 320 mg/day. Sustained ventricular tachycardia or fibrillation is reported in 0.8% of patients. Sinus bradycardia is reported in up to 13% of patients and predisposes patients to torsades de pointes.

Less common cardiovascular problems include worsened or new congestive heart failure in 0.4% to 3.3%, hypotension in 2%, and sinus arrest or AV block in 1% of patients.

Nervous system

Nervous system complaints are mainly limited to general fatigue, headache, or dizziness in up to 15% of patients. One case of sotalol-related depression has been reported.

Respiratory

Respiratory problems are mainly limited to dyspnea in 1% to 7% of patients. Like other beta-blockers, sotalol may inhibit beta-mediated bronchodilatory mechanisms, inducing wheezing in some patients with reactive airways disease.

Gastrointestinal

Gastrointestinal side effects include diarrhea, nausea, and vomiting in 1% to 5% of patients.

Metabolic

Metabolic changes are mainly limited to increased total serum triglycerides. Limited data show decreased HDL cholesterol associated with sotalol therapy. It is recommended that sotalol not be used in patients with preexisting hypokalemia or hypomagnesemia since these conditions may contribute to the proarrhythmic effects of sotalol.

Dermatologic

Six cases of sclerodermatous changes associated with sotalol therapy in patients with hyperthyroidism are reported.

Dermatologic side effects are uncommon. Two to 5% of patients develop a rash during sotalol therapy.

Musculoskeletal

Musculoskeletal side effects are extremely rare. Cases of retroperitoneal fibrosis, proximal muscle weakness, and facial atrophy associated with sotalol are reported.

A 55-year-old woman who was taking sotalol for hypertension developed a fever and bilateral hydronephrosis associated with retroperitoneal fibrosis which obstructed both ureters.

A 68-year-old woman with exertional angina pectoris developed proximal extremity weakness associated with elevated skeletal muscle creatine kinase 6 months after starting sotalol 80 mg every 8 hours. The problem persisted despite substitution with propranolol, and resolved when both drugs were withheld.

A 44-year-old man who was taking sotalol for hypertension developed facial atrophy after exposure to sub-zero weather. His facial muscle atrophy and edema were thought to be due to ischemia caused by the combined vasoconstrictive effects of the cold and beta-blockade.

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