The Food and Drug Administration (FDA) has issued the following safety alerts:
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction
The FDA is informing patients, caregivers, and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems. The FDA has not approved or cleared any ADM products for use in implant-based breast reconstruction. The FDA has completed an analysis of patient-level data from real-world use of ADMs for implant-based breast reconstruction which suggests that two ADMs—FlexHD and Allomax—may have a higher risk profile than others. More Information.
An FDA review of study findings showed a potential increased risk of cardiac arrhythmias in patients with heart disease who are taking lamotrigine (brand name Lamictal). Lamotrigine is FDA approved for the treatment of epilepsy and bipolar disorder. Laboratory testing performed at therapeutically relevant concentrations has shown that lamotrigine can increase the risk of serious arrhythmias, which can be life-threatening, in patients with clinically important structural or functional heart disorders. Clinically important structural and functional heart disorders include heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, cardiac channelopathies such as Brugada syndrome, clinically important ischemic heart disease, or multiple risk factors for coronary artery disease. The risk of arrhythmias may increase further if used in combination with other medicines that block sodium channels in the heart. Other sodium channel blockers approved for epilepsy, bipolar disorder, and other indications should not be considered safer alternatives to lamotrigine in the absence of additional information. More Information.