March 21, 2008

Neupro® patients - please consult your physician as soon as possible

Dear Patient,

Neupro® (rotigotine transdermal system) patches are being recalled in the United States and will not be available after the end of April 2008. The Neupro® patch is a transdermal delivery system worn on the skin and is used to treat early stage Parkinson's disease. It is made by Schwarz Pharma, a company of the UCB group.

You should take the following steps:
  • Do not stop taking Neupro without first talking to your doctor
  • Consult your physician as soon as possible

Your doctor will instruct you on how to gradually come off Neupro – this may take several days, depending on your current dose.

Some Neupro patches have snowflake-like patterns on them. The more snowflakes you see, the less likely it is that the patch will work properly.

Please refer to the pictures of patches below:
  • Patches with no snowflakes can be used.
  • Patches that look like picture A can be used.
  • Patches that look like picture B should not be used.

Contact your doctor if you have any questions about your medication or this letter. You may also contact UCB medical information directly at 1-800-477-7877 (option 9) if you have any questions.

Thank you for your understanding. We sincerely apologize for the inconvenience this may cause you.

Sincerely,

Kathleen Bos, MD
Vice President, U.S. Medical Affairs
UCB, Inc.

Learn How

 

A. You may use patches that have this amount of crystals, or less. The exact pattern or location of crystals on a patch may not look exactly like this.



 

B. Do not use patches that have this amount of crystals. The exact pattern or location of the crystals on a patch may not look exactly like this.

For Physicians
For Pharmacists
IMPORTANT SAFETY INFORMATION

Neupro® is indicated for the treatment of the signs and symptoms of early-stage idiopathic (meaning the cause is not known) Parkinson's disease. Some patients treated with Neupro reported falling asleep without any warning signs while engaged in activities of daily living such as driving, which sometimes resulted in accidents. Hallucinations such as seeing, hearing, or sensing things that were not real were reported in 2.0% of patients treated with Neupro compared to 0.7% of patients on placebo.

The most commonly reported side effects in clinical trials were nausea, application site reactions, somnolence (sleepiness), dizziness, headache, vomiting, and insomnia.

Neupro should be used with caution in patients, especially those at risk for heart disease, because of the potential for symptomatic hypotension (low blood pressure), syncope (feeling faint), elevated heart rate, elevated blood pressure, fluid retention, and/or weight gain. All Parkinson's disease patients are at a higher risk for melanoma (a type of skin cancer) and should be monitored regularly. Some patients who received Neupro experienced a decrease in blood hemoglobin. It is not known whether this change is readily reversible after stopping Neupro.

© Copyright 2008 UCB, Inc.

Neupro and Parkinson’s Patch are trademarks of UCB S.A. or its affiliates