June 8, 1998

Dear Doctor:

Roche Laboratories announced today the voluntary market withdrawal of the antihypertensive and anti-anginal medication POSICOR (mibefradil dihydrochloride).

The company is taking this action based on evolving information concerning the potential for drug interactions, some of them serious, that may occur when Posicor is taken together with some other medications. The decision follows the analysis of the preliminary results of a three-year long-term study of Posicor in congestive heart failure. The study demonstrated no overall difference between Posicor or placebo when added to standard therapy in this patient population, but it provided further information on drug interactions.

In both hypertension and chronic angina pectoris, Posicor has consistently proved to be effective and well tolerated, when used appropriately; however, the combination of Posicor and some other commonly used drugs, among them cardiovascular agents, may increase the frequency of the side-effects of these other medications. In principle, drug interactions can be addressed by appropriate labeling; however, with respect to Posicor, Roche Laboratories believes that the complexity of such prescribing information would make it too difficult to implement. As patient well-being is of highest priority to Roche, the company has decided to voluntarily withdraw the compound from the market.

The company is working closely with the Food and Drug Administration to inform physicians and other health care professionals of its decision.

Please immediately discontinue prescribing and dispensing Posicor, and immediately contact your patients who are currently prescribed Posicor so that they can discontinue treatment and receive appropriate alternative therapy. To receive a refund, patients should be instructed to immediately return any unused Posicor tablets via regular US mail to the following address:

Patients must include the following information when returning any unused Posicor tablets:

Patients will receive a refund based on the value of the number of tablets returned, not to exceed the price paid on the receipt, plus the cost of shipping via regular U.S. mail.

Effective immediately, the Posicor compliance program, PosiCare, will be discontinued.

In order to ensure a smooth return process, it is very important that you fill out and return the enclosed Business Reply Card (BRC). In addition, if you have any Posicor samples (50mg or 100mg tablets) in your office, please use the enclosed UPS shipping label(s) to return the samples to Capital Returns, Inc. at the same address listed above and on the shipping label. Please include your return address on each label.

If you have any questions, please call Roche Laboratories at 1-800-205-4611.

Sincerely,

Russell H. Ellison, MD
Vice President
Medical Affaris

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