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ROCHE RIMADYL LABEL INDICATIONS SECTION INCLUDES FOUR "CONCERNS"

Executive Summary

ROCHE RIMADYL LABEL INDICATIONS SECTION INCLUDES FOUR "CONCERNS" regarding adverse effects of the just-approved non-steroidal anti-inflammatory drug (NSAID). The "Indications and Usage" section of Rimadyl's FDA-approved labeling cites rash, alkaline phosphates and transaminase abnormalities, lower urinary tract symptoms, and leukopenia as four safety concerns. The indications section advises against use of Rimadyl as first-line therapy. Although "there is no clear evidence from clinical studies of greater risk" than other NSAIDs, the four concerns "can be resolved only by wider experience from domestic marketing," the label states. "Foreign experience is reassuring on these points, but it has not been extensive." Rimadyl is indicated "for acute or long-term use for the relief of signs and symptoms of the following: (1) Rheumatoid arthritis; (2) Osteoarthritis; (3) Acute gouty arthritis." Approved Dec. 31, Rimadyl was one of 21 new chemical entities cleared by FDA last year and one of 15 cleared in December ("The Pink Sheet" Jan. 4, p. 7). Roche is expected to launch the product by the second quarter of 1988. The placement of adverse experience information in the indications section is ironic in that Rimadyl originally was developed as an alternative to indomethacin and the gastric distress associated with it. Neither Motrin nor Clinoril, two other NSAIDs with favorable safety profiles, juxtapose uses and precautions within the indications section. The first concern listed in the indications section is that "carprofen causes more integumentary reactions, namely rash, than other NSAID agents." To date, the label notes, "these have been mild and reversible in clinical studies, with only a single possibly drug-related case of erythema multiforme; but rarer, more serious reactions have been reported in foreign marketing experience and their frequency cannot yet be assessed." The second concern is an observation that "carprofen caused 50-100% more abnormalities of alkaline phosphatase than control agents and abnormalities of transaminase at a rate lower than aspirin." However, the label continues, "the reactions in clinical studies were uniformly mild and were either evanescent on continued treatment or resolved quickly on discontinuation of therapy." Lower urinary tract symptoms, the third concern in the indications section, were caused by carprofen at a "higher than usual rate . . . than control agents." The label adds that "there was no evidence of renal injury except in two cases (see Precautions), neither of which could be clearly attributed to the drug." The fourth concern involves three instances of "marked leukopenia associated with carprofen in clinical studies." One of the instances was "probably" drug related, the label states, adding: "Such reactions have been seen with other NSAIDs in clinical trials, even when such reactions are known to be very rare with the drug involved."
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