December 23, 1996

Dear Doctor:

Somerset Pharmaceuticals, Inc. ("Somerset") manufactures and markets Eldepryl Capsules (selegiline HCl) for use as adjunctive therapy in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.

Somerset calls to your attention new safety information that has recently been included in the Clinical Pharmacology, Warnings, Information for Patients, and Precautions sections of the Eldepryl product labeling. The revised labeling notes that, although rare, a few reports of hypertensive reactions have occurred in patients receiving Eldepryl at the recommended dose (5 mg bid) associated with ingestion of tyramine containing foods. To date, two reports have been received. One additional case of a hypertensive reaction has been reported in a patient on the recommended dose of selegiline treated with levodopa plus carbidopa, lisuride, maprotiline, theophylline and a concomitant sympathomimetic medication, ephedrine. A more detailed description of this event can be found in Clinical Endocrinology, "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective monoamine inhibitor selegiline," (1995) 42, 95-99. although these reports are incomplete and do not constitute conclusive proof that the observed hypertension resulted from Eldepryl, it is prudent to include this information with our labeling.

While hypertensive events are rarely encountered when the labeled Eldepryl dose regimen is employed, these risks significantly increase when patients are exposed to higher doses. Accordingly, careful monitoring is required for patients who are prescribed Eldepryl in doses exceeding 10mg per day and for those patients who are transferred from one selegiline preparation to another.

For your convenience, Somerst has enclosed the revised labeling for Eldepryl Capsules.

Sincerely,

Cheryl D. Blume, Ph.D.
Executive Vice President
and Chief Operations Officer

Enclosure package insert coded ELD:R11

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