Signals for Acetaminophen, Dronedarone and Botulinum Toxin Products
In this issue of QuarterWatch™ we identified four signals of potential drug safety problems. These included safety signals for products containing acetaminophen, potential safety concerns about a new heart drug dronedarone (MULTAQ), and increased reports of complications for botulinum toxin products (BOTOX, BOTOX Cosmetic, DYSPORT).
QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.