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Recalled Transdermal PD Patch Should be Down-Titrated

Neurologists should down-titrate the Parkinson disease skin patch that contains rotigotine (Neupro) because of a recall that will cause supplies of the drug to run out soon, according to the drug's maker.

The FDA approved the rotigotine skin patch in May 2007 to treat symptoms of early Parkinson disease; it works by delivering rotigotine continuously through the skin using a silicone-based patch that is replaced every 24 hours. Rotigotine activates dopamine receptors in the body to compensate for the loss of dopamine-producing brain cells in PD.

Figure

Patches that have this pattern — or similar — of crystallization should be down-titrated.

The recall was prompted by a manufacturing problem that caused some patches to have lower doses of the medication and thus became less effective.

“The issue has been caused by the formation of alternative crystalline structures,” said Eric Miller, director of US Communications & Public Relations for UCB Group, the maker of rotigotine. “These structures have a reduced solubility that causes them to remain in the patch and decreases the amount of the active ingredient available for release from the patch.”

Figure

Patches that have this amount of crystals or less are usable.

Miller said UCB sent letters on March 21 to advise physicians and pharmacists of the recall.

The FDA approved the drug based on three parallel group studies funded by the patch manufacturer, Schwarz, of 1,154 patients with early-stage PD who were not taking other PD therapies. One January 2007 study in Neurology reported the drug significantly improved Parkinson symptoms — as measured by the Unified Parkinson's Disease Rating Scale —compared to the placebo group.

That study also reported that the patch caused a high incidence of skin reactions (44 percent in the rotigotine group versus 12 percent in the placebo group). However, the authors of an April 2007 paper in Neurology stated that a benefit of the patch is that it improves daily “off” time in patients with more advanced PD. “Many patients with PD experience immobility and other early morning discomforts before their first oral dose of medication takes effect,” they wrote. “This study demonstrated that rotigotine-treated subjects were more than twice as likely to be ‘on’ when waking compared to the placebo group.”

Anna DePold Hohler, MD, assistant professor of neurology at Boston University and a member of the AAN Patient Safety Committee, said that she and her staff are using an electronic medical records system to search for patients who are currently taking rotigotine to let them know that they will be tapered off the patch and transitioned to a similar dopamine agonist. These include ropinerole, pramipexole, and bromocriptine.

Gradually titrating patients off rotigotine, which is widely prescribed, will ensure patients won't experience a significant worsening in symptoms, Dr. Hohler said.

For more information call 1-800-477-7877 (option 9) or visit neupro.com.

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REFERENCES

Watts RL, Jankovic J, Rao J, et al. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007;68:272–276.
LeWitt PA, Lyons KE, Pahway R, et al., for SP 650 Study Group. Advanced Parkinson disease treated with rotigotine transdermal system: PREFER study. Neurology 2007;68:1262–1267.