Drug Warnings Archive

FDA Drug Warnings - June 2021




The FDA has published a Drug Safety Communication to advise patients and health care providers of a potential for increased risk of serious or life-threatening arrhythmias in patients with heart disease who are taking lamotrigine.

The FDA advises using the drug cautiously in patients with structural and functional heart disorders, including heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, cardiac channelopathies, ischemic heart disease, or multiple risk factors for coronary artery disease, especially when used in combination with sodium channel-blocking drugs, such as carbamazepine, phenytoin, and topiramate. Health care providers should assess whether the potential benefits of lamotrigine use outweigh the risk of arrhythmia for each patient.

Patients should be educated to seek immediate medical attention for abnormal heart rate or irregular rhythm, or symptoms such as a racing heartbeat, skipped or slow heartbeat, shortness of breath, dizziness, or fainting.

Adverse effects from the use of lamotrigine should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: June 2021

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