From the September 2007 issue

Earlier this month, Shire Pharmaceuticals announced a voluntary market withdrawal of a limited portion of DAYTRANA (methylphenidate transdermal system) due to the difficulty patients and caregivers were having removing the release liner of some patches. Packages with an expiration date of March 31, 2009 or earlier as well as packages with lot numbers 2563511, 2563611, and 2570411 are impacted by this voluntary market withdrawal. In our June 2007 issue, we reported steps parents have been taking to keep the patches affixed to their children’s skin (e.g., refrigerating patches, using bandages to tape patches to the skin). Shire expects remaining Daytrana patches, which are not subject to the market withdrawal, to offer patients and caregivers improved ease of use when peeling the release liner off the patch. The more recent patches have been manufactured using an enhanced process. Please inform your patients about this withdrawal. Encourage patients to continue to report any problems they are having with Daytrana. Other than patient satisfaction surveys, Shire is relying on voluntary reports to monitor the efficacy of the enhanced manufacturing process. Unfortunately, we’ve learned that Shire has not proactively conducted usability testing with actual patients and practitioners to identify potential problems. Patients and their caregivers who have questions regarding Daytrana patches should call Shire customer service at 1-800-828-2088, option 1.