Schwarz Pharma Neupro (rotigotine) transdermal patches recalled

Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease.

The problem is that rotigotine, the active ingredient, may crystallize in the patch. If that happens, less drug is available to be absorbed through the skin and so the efficacy of the products may vary. The crystallized drug may cause a patch to have snowflake-like patterns. The more snowflakes, the greater the chance that the patch won't work properly.

Because of this, new patients should not be started on Neupro. Patients already using the patch should be slowly titrated off it, and started on an alternative treatment as needed. Patients should not abruptly discontinue treatment with Neupro. The down-titration should proceed according to guidelines in the labeling, using patches that are unaffected or minimally affected by the crystallization.

Patients should be told to look at their patches and only use those that have a minimal amount of crystals. (See link below for picture.) For more information, contact the company at 1-800-477-7877 (option 9).

Additional Information:

FDA MedWatch Safety Alert. Neupro (rotigotine transdermal system). April 9, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#neupro