Europe. The EMEA has recommended the suspension of the marketing authorization of a system (Ionsys) for the transdermal delivery of fentanyl, an opioid analgesic. This drug delivery system marketed by Janssen-Cilag International NV, has a defect that could lead to patients being overdosed. It has been authorized in the European Union (EU) since January 2006 and is indicated for the in-hospital management of acute, moderate to severe post-operative pain. The system is activated on demand by the patient in response to pain.
There have been no reports of serious adverse events associated with the malfunction of the device, in particular no reports related to self-activation of the system, or of overdose as a result. However, the Janssen-Cilag recalled all systems from the EU in September 2008 as a precautionary measure. As a consequence, Ionsys is unavailable and patients have been switched to alternative treatments.
EMEA, 20 November 2008 (www.emea.europa.eu).