2 December 2009
Dear Prescriber,
Advance Notice - Stock Shortage
SINEMET CR
® Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ, USA
We write to inform you that Australia will experience a significant shortage in the supply of SINEMET CR for approximately one year - starting in early 2010 and continuing into 2011.
Supplies of the immediate release formulation of SINEMET - SINEMET 100/25 mg and SINEMET 250/25 mg tablets - are not expected to be affected by the shortage of SINEMET CR.
The shortage in SINEMET CR is not related to any product quality or safety issue.
This temporary global shortage of SINEMET CR is related to a change in the source of supply and the necessary time needed to obtain regulatory approval for the change. This means that SINEMET CR will not be available for allcurrent patients.
At this time, it is estimated that initially only 20-50%* of patients will be able to receive uninterrupted supply of SINEMET CR in 2010. We seek your assistance in helping to ensure that the limited supplies of SINEMET CR will be available for those patients with the greatest need - those for whom there are no suitable alternatives. In order to support the patients with the greatest need it is hoped that, where medically appropriate, 50-80%* of patients on SINEMET CR may be switched to
alternative treatments.
We kindly ask that you review all patients in your care on SINEMET CR as soon as possible to determine the appropriateness of alternative treatments prior to commencement of the expected shortage in early 2010.
SINEMET CR is currently available on the PBS as an Authority Required item with the following restriction:
Parkinson's disease where fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor.
We appreciate your management concerns for your patients, especially for those whose symptoms are difficult to control. Your assistance in enabling a limited number of patients to receive continued supply through this difficult period is greatly appreciated.
Notice of the shortage of SINEMET CR is being communicated to neurologists, geriatricians and general practitioners in the first instance. Pharmacies will be informed of the stock shortage in a separate communication.
For further information, please contact our Medical Information Department on 1800 645 712.
Yours faithfully,
Dr Troels Wolthers
Medical Director
* Exact allocation will be known in January 2010