Focus on Newly Approved Drugs

In this issue of QuarterWatch™, we focus on key findings from the adverse drug event reports from 97 drugs and biological products first approved by the U.S. Food and Drug Administration (FDA) from 2015 to 2017. We examine the emerging safety profile of a new generation of cholesterol-lowering drugs, called PCSK9 inhibitors, that reduce low-density lipoprotein (LDL) by 45%-60%. Signals are examined for the two newest treatments for psoriasis that target forms of interleukin-17A, a component of the complex immune response. Another immunosuppressant–targeting a different form of interleukin­–was approved to treat atopic dermatitis but is linked to conjunctivitis and other eye disorders.

The biological products and target disorders are:

Serious cardiovascular disease

• Evolocumab (Repatha)
• Alirocumab (Praluent)

Moderate-to-severe psoriasis

• Secukinumab (Cosentyx)
• Ixekizumab (Taltz)

Atopic dermatitis in adults not controlled with topicals

• Dupilumab (Dupixent)

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.