Information about the temporary global supply shortage of SINEMET AND SINEMET CR

29 July 2010

• Letter from: Dr. Michael Rosenblatt, Chief Medical Officer, Merck & Co., Inc
  
• Table of availability of SINEMET® and SINEMET CR®
• Contact details of MSD offices in Europe should you have any further enquiries
  

Letter from: Dr. Michael Rosenblatt, Chief Medical Officer, Merck & Co., Inc

Dear Ms. Graham:

Merck (known as MSD outside the U.S. and Canada) is currently managing a temporary global supply shortage of SINEMET® (carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release), which are Merck's Parkinson's disease products.  I would like to personally express our sincere apology for this supply interruption.  Merck is doing its best to restore supplies as soon as possible and sincerely regrets any inconvenience or distress this interruption has caused to people who rely on SINEMET.

The extent of this supply shortage varies from country to country.  Although our supply estimates change from time to time, all dosage strengths of SINEMET IR (immediate release) are now fully available in most markets, and SINEMET CR is in the process of being re-supplied. We expect SINEMET CR to be fully available by mid 2011 to most markets, contingent on regulatory approvals (see below).  

In the meantime, Merck is managing available supply of SINEMET through an allocation system to optimize use of available stock.  For obvious ethical reasons, one main criteria we take into consideration for supply allocations is whether alternative generic medicines are an option in a country.  In many countries, tablets containing the same active ingredient as SINEMET (e.g, generic equivalents) are available from other manufacturers.   

With respect to these generic equivalents – which are tablets containing the same active ingredient as SINEMET – Merck understands how difficult it is for any patient who may not be able to receive their usual medication.  We know that it can be difficult to find the optimum treatment regimen for Parkinson's patients and we know that it can be difficult to change therapies.  While we recognize that some patients may object to having their physicians switch their therapy from a branded to a generic medicine, it is a medically appropriate option and a common occurrence in clinical practice. We encourage all patients and caregivers who have questions about their treatment options to speak to their health care provider.

Finally, please contact our local MSD office for information about the current supply of SINEMET in your country, as well as what generic equivalents containing the same active ingredient as SINEMET are marketed in your country.  

Please be assured that Merck takes this matter very seriously and intends to always act in the best interests of patients in these difficult circumstances.  We are committed to urgently working towards a stable supply of SINEMET as soon as possible.

Sincerely,