New Safety Perspectives - January 2016

This issue of QuarterWatch™ features a broader scope of review to include more data and to adapt to changing reporting patterns. Previous issues focused primarily on the subset of domestic cases with a serious outcome.

In this issue we examine safety questions about drugs used in three of the largest patient populations in medicine: BELSOMRA, a new drug for chronic insomnia, a problem which affects 10-30% of all adults; changes in the use of opioid medications for moderate to severe pain, a near universal issue in most lives at some point; and a new family of drugs for Type 2 diabetes, a disorder for which 21% of those age 65 years or older are currently being treated.

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.