The most common side effects in the three trials included dizziness, nausea, vomiting, drowsiness, and insomnia, “most of which are typical for this class of drugs,” according to the FDA statement announcing the approval. Nearly 40% of those on the patch had application site reactions-mostly mild or moderate-compared with 14% among those who received a placebo patch. The drug's label includes a warning about sulfite sensitivity, because the delivery system contains a sulfite that may cause allergic reactions.
The rotigotine patch is not approved for advanced disease, but it is being studied in this population. In a recently published placebo-controlled 24-week study of the rotigotine patch in 351 patients with advanced Parkinson's, those treated with two doses of the patch had significant reductions in the amount of daily “off” time than those on placebo (Neurology 2007;68:1262–7).