Neupro Patch Recall Press Release - Parkinson Foundation of the National Capital Area

UCB Advises US-Physicians to Down-Titrate Patients on Neupro In View of Out-of-Stock Situation

PharmaLive.com - BRUSSELS, Belgium - March 20, 2008 at 7:00 am CET - UCB announced today that the company will be recalling Neupro® (rotigotine transdermal system) in the United States and certain batches in Europe. The recall decision resulted from 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 United States in late April 2008. In the European Union and most other regions Neupro® supply is sufficient.

"We have informed the FDA and agreed to actions to inform healthcare providers and patients," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, 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."

Down-titration (reduction of the dose) should be gradual and performed under medical supervision. Rapid reduction of therapy for Parkinson's disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.

PFNCA, Chapter of the NPF - 8300 Greensboro Drive, Suite 800, McLean, VA 22102
Telephone: 703.287.8729 Fax: 703.918.4847
E-Mail: pfnca@parkinsonfoundation.org WEB: www.parkinsonfoundation.org

Copyright 2000-2006 Parkinson Foundation of the National Capital Area. All rights reserved worldwide.

Disclaimer: This web site is not being used to make diagnoses, administer treatment, prescribe medications, or order tests. The information contained is provided as an educational service, which can assist you in your personal research on Parkinson's Disease. This web site is not a replacement for the relationship you have with your healthcare provider. Any information provided is not medical advice and should not be substituted for regular consultation with your healthcare provider. If you have any concerns about your health, please contact your healthcare provider's office immediately.



	Last Updated: 23-Mar-2008
Home Donate Online About Parkinson's Disease About US Newsletters Patient Programs Support Groups Useful Links Contact Us
		This information below is intended to provide general background information about Parkinson's disease. Your physician can provide you with more detail and fully address your specific questions and treatment needs.

		UCB Advises US-Physicians to Down-Titrate Patients on Neupro In View of Out-of-Stock Situation PharmaLive.com - BRUSSELS, Belgium - March 20, 2008 at 7:00 am CET - UCB announced today that the company will be recalling Neupro® (rotigotine transdermal system) in the United States and certain batches in Europe. The recall decision resulted from 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 United States in late April 2008. In the European Union and most other regions Neupro® supply is sufficient. "We have informed the FDA and agreed to actions to inform healthcare providers and patients," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, 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." Down-titration (reduction of the dose) should be gradual and performed under medical supervision. Rapid reduction of therapy for Parkinson's disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.
	PFNCA, Chapter of the NPF - 8300 Greensboro Drive, Suite 800, McLean, VA 22102 Telephone: 703.287.8729 Fax: 703.918.4847 E-Mail: pfnca@parkinsonfoundation.org WEB: www.parkinsonfoundation.org Copyright 2000-2006 Parkinson Foundation of the National Capital Area. All rights reserved worldwide. Disclaimer: This web site is not being used to make diagnoses, administer treatment, prescribe medications, or order tests. The information contained is provided as an educational service, which can assist you in your personal research on Parkinson's Disease. This web site is not a replacement for the relationship you have with your healthcare provider. Any information provided is not medical advice and should not be substituted for regular consultation with your healthcare provider. If you have any concerns about your health, please contact your healthcare provider's office immediately.