Neupro Supplies Expected to Run Out Following Recall of Parkinson's Disease PatchMar 21, 2008 | Parker Waichman LLP
Neupro, a medicated patch used in the treatment of Parkinson's Disease, has been recalled by its manufacturer, UCB SA in the United States and Europe. Because of the Neupro recall, supplies of this medication in the United States are expected to run out soon, and doctors are being advised to take steps to wean their patients from Neupro.
Neupro, approved by the Food & Drug Administration (FDA) in 2007, was the first transdermal patch used for the treatment of early-stage Parkinson's Diseases. Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Neupro delivers the medication rotigotine, a member of the dopamine agonist class of drugs, continuously through the skin using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine.
According to a UCB press release, the company is recalling all Neupro patches in the United States, as well as some lots of the medication in Europe, after uncovering a “deviation from the approved product specification”. The company was not specific about the nature of the Neupro defects, but said they were “not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches”. UCB did say that because of the recall, it expects supplies of Neupro to run out in the United States within the next few months.
Because of the anticipated Neupro shortage, UCB is strongly advising healthcare professionals and patients not to abruptly stop their therapy. Rather, dosing should be gradually reduced instead under medical supervision to avoid certain complications. Rapid reduction of therapy for Parkinson's disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.
The Neupro problems are just the latest bad news UCB has had to endure. Earlier this month, the company announced it was revising the labeling of its prescription cough suppressant Tussionex Pennkinetic Extended-Release Suspension, to warn of its association with fatal overdoses. Tussionex is one of eight prescription cough medicines that contain the narcotic pain reliever hydrocodone. Hydrocodone is habit-forming, and can lead to physical and psychological addiction. A hydrocodone overdose is possible when too much of the drug is used. Five deaths have been reported among children under 6 who took the Tussionex since its approval in 1987, despite the fact that Tussionex has only been approved for adults and children over 6.
UAB said that it is too early to tell how the Neupro recall will affect its bottom line, however, the company said it is reviewing and may have to restate its 2008 financial outlook.