The recall decision resulted from the ongoing monitoring of marketed product, which revealed a deviation from the approved product specification. As a result, there will be an out-of-stock situation with Neupro in the US in late April 2008. In the EU and most other regions Neupro supply is sufficient.
Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease in the US and early and late stages of the disease in Europe and is distributed by Schwarz Pharma, a company of UCB Group.
Iris Loew-Friedrich, chief medical officer of UCB, said: “We have informed the FDA and agreed to actions to inform healthcare providers and patients. We advise patients in the US to contact their healthcare provider to begin the down-titration of Neupro as per the guidelines in the label. It is strongly advised that patients do not discontinue therapy abruptly.”