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May 11, 1964

The Public Interest and Drug Recall

JAMA. 1964;188(6):612. doi:10.1001/jama.1964.03060320132033

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To the Editor:—  Many of us in the private practice of medicine were surprised and shocked by the sudden order on Feb 24, 1964, of the Food and Drug Administration recalling tranylcypromine (Parnate) sulfate from public use.The problem raised by this action involves much more than this particular edict. Several questions arise.

  1. What is the actual incidence of side reactions with tranylcypromine? The occurrence of about 50 cases which resulted in cerebrovascular accidents and of 15 cases terminating in death is significant only in terms of incidence. Among the 3.5 million patients who have used this drug, there would thus be an incidence of one death in 230,000 patients and one case of cerebrovascular accident in 70,000 patients. Since many aging persons were taking this drug, the question arises as to whether the reported side effects were consequential to or coincidental with the use of tranylcypromine.

  2. Is

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