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CIBA-GEIGY BUTAZOLIDIN LABEL REVISIONS HIGHLIGHTED IN MD/PHARMACIST INFO CAMPAIGN

Executive Summary

Ciba-Geigy's removal of the "painful shoulder" indication from its Butazolidin (phenylbutazone) labeling is being highlighted in an MD-pharmacist information campaign begun by the firm April 29. The campaign, which corresponds to the company's withdrawal of Tandearil oxyphenbutazone) from the market and revised labeling for Butazolidin, includes Dear Doctor/Pharmacist letters which note: "Of major importance is the removal of Painful Shoulder (i.e., peritendinitis, capsulitis, bursitis, and acute arthritis of that joint) from the section entitled 'Indication and Usage.'" Ciba-Geigy VP George Ehrlich explained the program to FDA's Arthritis Drugs Advisory Cmte. at its April 29 meeting (see related story). He noted that the information campaign "is designed in its first mailing to reach 214,000 physicians. Of that group, 65,000 are considered actual Butazolidin prescribers and they will receive a repeat mailing two weeks later." Included in the mailing are the following: a letter to physicians advising them of the modified prescribing information; a copy of the patient information leaflet; and a file card identifying for the physician the key changes to the Butazolidin package insert, including a complete copy of the insert. The "Dear Doctor" letter notes that prescribing information for Butazolidin now includes advice that "it is not a simple analgesic and should never be administered casually. Now a boxed warning has become a permanent part of its P.I. -- pointing out the risk of developing aplastic anemia and agranulocytosis and advising that Butazolidin only be used after other nonsteroidal anti-inflammatory drugs have been tried and found unsatisfactory." Cmte. Chairman Michael Weisman, MD, University of California Medical Center noted that in the company's slide presentation to the cmte., and in the press release, specific mention is made of the four indications for which Butazolidin is recommended (active ankylosing spondylitis, active gouty arthritis, active rheumatoid arthritis, acute attacks of degenerative joint disease of the hips and knees). He suggested that the same wording be contained in the "Dear Doctor" letter. "It seems the 'Dear Doctor' letter might be stronger if it included and highlighted the fact not that [Painful Shoulder] was deleted, but that there are only four indications for the use of the drug," Weisman said.

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