The Food and Drug Administration has required a Risk Evaluation and Mitigation Strategy (REMS) for MULTAQ. A REMS is a strategy to manage known or potential serious risk(s) associated with a drug product, and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.
The MULTAQ REMS program, also referred to as MPACT, is designed to inform health care professionals, including cardiologists, electrophysiologists, hospitalists, internal medicine, family practice physicians, and hospital, clinical, and retail pharmacists about the risks with MULTAQ. Additionally, nurse practitioners and physician assistants who work in offices of the above-mentioned physicians will also be targeted.
To learn more about the serious risks of MULTAQ, CLICK HERE for full Prescribing Information, including boxed WARNING.
The goals of the MULTAQ REMS are:
Materials for Healthcare Providers:
To read the FDA Drug Safety Communication: Severe liver injury associated with the
use of dronedarone (marketed as MULTAQ),
please CLICK HERE.
To read the FDA Drug Safety Communication: Review update of MULTAQ (dronedarone) and increased risk of death and severe cardiovascular adverse events, please CLICK HERE.