Perspectives In This Issue
In this issue of QuarterWatch™ we analyze severe gastrointestinal toxicity and hypersensitivity reactions reported for the new oral drug for multiple sclerosis (MS), dimethyl fumarate (TECFIDERA).
The risks of serious psychiatric side effects are highlighted in a new analysis of varenicline (CHANTIX), an aid to smoking cessation.
We also examine the frequent and broad spectrum of serious adverse effects on the brain of sodium oxybate (XYREM), an orphan drug for narcolepsy.
Cardiac, ocular, infection, and pregnancy risks are reviewed for a second newer MS drug, fingolimod (GILENYA).
QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US 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.