November 7, 1996

Dear Doctor:

Re: Discontinuation of Trancopal® (chlormezanone)

A recent retrospective European enquiry has reassessed the risk of occurrence of serious cutaneous reactions associated with the use of chlormezanone-containing products.

The results confirm, as presently warned, the low incidence of serious reactions (toxic epidermal necrolysis). They also reveal differences in the benefit/risk assessment between countries, depending on local prescribing practices and therapeutic alternatives. It should be emphasized that there are also differences between the United States and European countries in the indications for which chlormezanone products are approved but that the safety profile of Trancopal in this country has not altered.

In France, where our parent company is based, it has been agreed with the Regulatory Agency that Sanofi discontinue chlormezanone products. Sanofi has elected to extend this decision to all other countries in which it markets such products. We wish to advise you therefore that we shall discontinue supplying Trancopal on November 15th, 1996. Given that the product will no longer be available, you should consider prescribing alternative treatment.

Should you like more information, please call our Product Information Department at 1-800-446-6267.

Sincerely,

Dr. Charles G. Nicol
Senior Medical Director