QuarterWatch™ Reports October 2016

Problems with a Patch and a Self-Injection Pen

In this QuarterWatch™ issue, we examine two signals for problems with devices that administer drugs to patients rather than the underlying risks of the drugs themselves.

The Zecuity transdermal patch delivered sumatriptan for acute migraines with a novel technology using small electrical currents to deliver the drug ions through the skin and into body circulation. The Zecuity patch was withdrawn after just nine months on the market because of burns, scarring, and other skin injury.

Also, we discovered patients were struggling to use the once-weekly self-injection pen for albiglutide (TANZEUM), a recently approved drug for type 2 diabetes.


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.  We also receive dispensed outpatient prescription data from IMS Health Inc.