Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

SOTALOL HYDROCHLORIDE (NDA-022306)

(SOTALOL HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/23/2025 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Proarrhythmia

Additions and/or revisions underlined:

Sotalol can cause serious and potentially fatal ventricular arrhythmias , primarily Torsade de Pointes (TdP), a polymorphic ventricular tachycardia associated with QTc prolongation. QTc prolongation is directly related to the concentration of sotalol. Factors such as reduced renal function, female sex, higher dose, bradycardia, history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), atrial fibrillation with sinus node dysfunction, and heart failure increase the risk of TdP. The risk of TdP can be reduced by adjustment of the sotalol dose according to renal function and by monitoring the ECG for excessive increases in QTc.

. . .

Proarrhythmic events should be anticipated upon initiating therapy and with every up-titration of sotalol.

. . .

5.2 Bradycardia/Atrioventricular (AV) Block

Subsection title revised

Additions and/or revisions underlined:

Sotalol can cause bradycardia, sinus pauses or sinus arrest. Sotalol-induced bradycardia increases the risk of Torsade de Pointes, particularly following cardioversion. Monitor the ECG in patients receiving concomitant negative chronotropes [see Drug Interactions (7.2, 7.3, 7.4)].

7 Drug Interactions

7.1 Antiarrhythmic and Other QT Prolonging Drugs

Newly added subsection

Withdraw other Class I or Class III antiarrhythmic agents prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy, because of their potential for additive QTc prolongation [see Warnings and Precautions (5.1)].

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Sotalol is indicated for:

The treatment of documented, life-threatening VT in pediatric patients.

The maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in pediatric patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.

The Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in pediatric patients between 3 days and 12 years of age [see Clinical Pharmacology (12.3)].

Side effects from use of other sotalol-containing drug products in pediatric patients are those typical of a beta blocking agent, and led to discontinuation of the drug in 3 to 6% of patients. As in adults, the Class III antiarrhythmic action of sotalol in pediatric patients is associated with a significant proarrhythmic potential. In pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; and the smallest pediatric patients tended to exhibit greater QTc-prolongation [see Clinical Pharmacology (12.2)] ].

Proarrhythmic effects of sotalol in pediatric patients included increased ventricular ectopy and exacerbation of bradycardia, the latter predominantly in patients with sinus node dysfunction following surgery for congenital cardiac defects. Bradycardia may require emergency pacemaker implantation.

Close inpatient monitoring is recommended until steady state drug levels are achieved [see Dosage and Administration (2.1, 2.3)].

8.6 Renal Impairment

Newly added subsection:

Sotalol is eliminated predominantly via the kidney [see Clinical Pharmacology (12.3)]. Sotalol exposure increases with decrease in renal function. Sotalol dose should be reduced and interval between doses should be increased based on the patient’s renal function [see Dosage and Administration (2.2, 2.3)].

09/21/2023 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Hypoglycemia

Subsection title revised

Additions and/or revisions underlined:

Beta-blockade may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or vomiting). Monitor blood glucose as appropriate.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added section:

Risk of hypoglycemia

Inform parents or caregivers that there is a risk of hypoglycemia when sotalol is given to patients who are fasting or who are vomiting. Inform patients to notify their healthcare provider if they experience symptoms of hypoglycemia. [See Warnings and Precautions (5.7)].

03/06/2020 (SUPPL-5)

Approved Drug Label (PDF)

Boxed Warning

(Extensive changes; please refer to label)

4 Contraindications

(Additions and/or revisions underlined)

Sotalol hydrochloride is contraindicated in patients with:

· Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemaker

· Congenital or acquired long QT syndromes, QT interval >450 ms

· Cardiogenic shock, decompensated heart failure

5 Warnings and Precautions

Bradycardia/Heart Block

(Extensive changes; please refer to label)

Bronchospasm

(Newly added subsection)

Heart Failure

(Extensive changes; please refer to label)

Hypotension

(Additions and/or revisions underlined)

Sotalol produces significant reductions in both systolic and diastolic blood pressures. Monitor hemodynamics during administration.

Masked Signs of Hypoglycemia in Diabetics

(Newly added subsection)

Proarrhythmia

(Extensive changes; please refer to label)

Thyroid Abnormalities

(Newly added subsection)

6 Adverse Reactions

(Extensive changes; please refer to label)

7 Drug Interactions

(Extensive changes; please refer to label)

8 Use in Specific Populations

Lactation

(PLLR conversion. Please refer to label for complete information.)

Pregnancy

(PLLR conversion. Please refer to label for complete information.)