Belgian pharmaceutical company UCB has recalled Parkinson's disease patch treatment Neupro in the US after finding a reduced clinical performance in some.
Certain batches of the patch will also be recalled in Europe, the company said. As a result of the recall decision, Neupro will be out of stock until April 2008.
"We have informed the Food and Drug Administration (FDA) and agreed to actions to inform healthcare providers and patients," said Iris Loew-Friedrich, chief medical officer for UCB.
"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.
"I also want to emphasize that the issue is not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches."
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.
The full effect of the recall on UCB's business is not yet known, the company said. Therefore, UCB's 2008 financial outlook is under review and will be updated as soon as possible.
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