QuarterWatch™ Reports April 2017

Depression and Suicidal Behaviors

In this issue of QuarterWatch™, we focus on depression and suicidality as adverse effects of therapeutic drugs. One part of our analysis focuses on two newer drugs with notably different medical uses. Apremilast (OTEZLA) is a drug for severe forms of psoriasis, while roflumilast (DALIRESP) is used to treat chronic obstructive pulmonary disease (COPD). But they share a risk of these psychiatric side effects though a common mechanism of action: inhibiting a widely distributed intracellular enzyme called phosphodiesterase-4 (PDE4).

Also, a new perspective on risks of suicidal thoughts and behaviors comes through examining some striking cases of suicide and suicidal thoughts after taking suvorexant (BELSOMRA) that began when patients missed a dose or stopped the drug.

Separately, we examine serious injuries reported for aspirin.


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.