close :

:

Forgotten your password?
 
Pharma Industry News
Printable Version   Email to a friend

FDA MedWatch-Neupro (rotigotine transdermal system)- Product Recalled Due To The Formation Of Rotigotine Crystals In The Patches

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ROCKVILLE, Md, April 10 2008-Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson's disease. The product is being recalled because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA's Drug Shortage Information Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#neupro

Latest Pharma Industry News...

Pharma Industry News Archive

2008: Jan | Feb | Mar | Apr | May | Jun | Jul
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec

More News Resources


Most Popular Internet Searches
Latest FDA Drug Alerts
July 24, 2008
Audience: Infectious disease and medical genetics healthcare professionals[Posted 07/24/2008] FDA informed healthcare...
July 17, 2008
Audience: Radiological healthcare professionals, cardiologists, hospital risk managers [Posted 07/17/2008] FDA is updating...
July 16, 2008
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals [Posted 07/16/2008] FDA informed...
July 16, 2008
Audience: Pharmacists, hospital risk managers, other healthcare professionals[Posted 07/16/2008] Roxane Laboratories, Inc....
More...
Latest Drug Information Updates

Eovist
Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Evolence
Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

Kinrix
Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.

Durezol
Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

PrandiMet
PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.

Pentacel
Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

Trivaris
Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Entereg
Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

OraVerse
OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.

Aplenzin
Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.

Cimzia
Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults.

Relistor
subcutaneous injection for the treatment of opioid-induced constipation

Treximet
Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines, and an anti-inflammatory pain reliever in a single tablet.

Patanase
Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.

Lexiscan
Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.

More...