New Drugs for Flu, Migraines

In this issue of QuarterWatch™, we examine the emerging safety profiles of four newly approved drugs that address major medical needs: a new antiviral treatment for influenza symptoms and three biological products intended to reduce the number of monthly migraine headaches with an entirely new mechanism of action. Postmarket surveillance is most important when drugs are new, and many questions are still unanswered. We also look at manufacturer performance in reporting adverse effects of these four new drug launches in 2018-2019.

We examine the emerging safety profile of these drugs: baloxavir (XOFLUZA), the first new antiviral treatment for influenza in nearly 20 years and three new biological products for migraines: Erenumab-aooe (AIMOVIG), Fremanezumab-vfrm (AJOVY), and Galcanezumab-gnlm (EMGALITY).

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.