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US Info: Roche Drug Withdrawal

 Roche Announces Voluntary Withdrawal of POSICOR(R)
 1-800-205-4611 for Questions

NUTLEY, N.J., June 8 /PRNewswire/ -- Roche today announced the voluntary market withdrawal of the anti-hypertensive and anti-anginal medication POSICOR(R) (mibefradil) and is advising physicians to propose alternative therapies to their patients.

The company is taking this action based an evolving information concerning the potential for drug interactions, some of them serious, which 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 believes that the complexity of such prescribing information would make it difficult to implement. As patient well-being is of the highest priority to Roche, the company has decided to voluntarily withdraw the compound from the market.

Roche is working closely with the Food & Drug Administration to inform physicians and other health care professionals of its decision. Patients should not simply discontinue treatment with POSICOR; instead they should consult their physicians promptly about appropriate alternative therapy. In addition, patients should not add any new medication to their present treatment without consulting their physician. Information about the withdrawal for both healthcare professionals and consumers will be communicated via:

-- A special hotline, 1-800-205-4611

-- A nationally distributed letter to physicians, pharmacists, nurse

practitioners, physician assistants and other health care professionals

-- Communication of patient information through physicians, pharmacies,

local/national constituency groups and community groups

SOURCE Roche Laboratories
 -0- 06/08/98

/NOTE TO EDITORS: This release will be refed at 8 a.m. EDT, June 8./

/CONTACT: Valerie Suga of Roche Laboratories, 973-562-2174/

CO: Roche Laboratories ST: New Jersey IN: MTC SU:

DK-ES -- NYM006 -- 0646 06/08/98 02:00 EDT
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Publication:PR Newswire
Date:Jun 8, 1998
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