Scope of Injury from Therapeutic Drugs

In this issue of QuarterWatch™  we examine opposite trends in the medical use of two classes of drugs with the highest risk of dependence, addiction, and abuse: therapeutic opioids with a sharp decline in use, and prescribed amphetamine-like stimulants with a rapid increase in adults and more modest growth in use in children. In addition, we examine the continuing problem of methotrexate medication errors with harmful and fatal outcomes. We also investigate the extent of underreporting of serious adverse drug events to the U.S. Food and Drug Administration (FDA).

We examine the downward trends the therapeutic use of many opioids, including fentanyl, acetaminophen-hydrocodone,  tramadol. Increases were seen in a new abuse resistant form of hydrocodone (HYSINGLA) and little change was seen in use of oxycodone (OXYCONTIN).

In contrast, we analyze the increased use of prescribed amphetamine-like stimulants such as amphetamine-dextroamphetamine (ADDERAL XR, others), lisdexamfetamine (VYVANSE), and methylphenidate (CONCERTA, others).

Five drugs were used for case studies of how many adverse drug events that occurred were being reported to the FDA Adverse Event Reporting System (FAERS). The estimated reporting rates varied from less than 1 in 1,000 cases reported to 7.6% of cases. The drugs examined were meloxicam (MOBIC), celecoxib (CELEBREX), apixaban (ELIQUIS), adalimumab (HUMIRA), and risperidone (RISPERDAL).

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the Food and Drug Administration’s 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.