February 7, 1997

Dear Health Care Professional,

We are writing you this letter to advise you of three serious adverse events which have recently occurred following the use of Paremyd (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% for routine diagnostic purposes. The three events included a patient who sustained a fatal myocardial infarction, a second patient who developed ventricular fibrillation who was successfully resuscitated, and a third patient who developed hypotension, bradycardia, and syncope requiring intervention.

These recent, rare events are the only serious adverse events with Paremyd solution usage reported to Allergan since the drug was first introduced in 1993. Since that time, more than 165,000 units of Paremyd solution have been sold, representing potentially as many as 16 million individual patient uses with these three being the only reported serious adverse events.

Although temporally, associated with dosing of Paremyd solution, there is no evidence that any of the above events were attributable to the use of the drug. Nevertheless, we wish to remind you that Paremyd solution combines both sympathomimetic and parasympatholytic agents and that all such compounds have known potential effects on the cardiovascular system. Although we have no reason to suspect that Paremyd solution is any less safe than other commonly used mydriatic/cycloplegic agents used in combination (for example, cyclopentolate and phenylephrine), we advise you to keep the known pharmacology of these compounds in mind when using them.

Full prescribing information is on the back of this letter for your reference.

Very truly yours,

Joseph N. Lambert, M.D.
Medical Monitor
Opthalmology Clinical Research

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