FLOCTAFENINE - A VALID ALTERNATIVE IN PATIENTS WITH ADVERSE REACTIONSTO NONSTEROIDAL ANTIINFLAMMATORY DRUGS

Background: Choosing an alternative anti-inflammatory agent for a pati ent who has suffered adverse reactions to nonsteroidal anti-inflammato ry drugs is a common problem in clinical practice, and it is complicat ed by the possibility of non-immunologic cross reactivity among the va rious members of this drug class. Objective: We performed a retrospect ive study based on oral challenge results in 150 patients with histori es of adverse reactions to one or more nonsteroidal anti-inflammatory drugs. The alternative drugs tested included floctafenine, an analgesi c of the fenamic acid group, nimesulide, or paracetamol (acetaminophen ). Patients and Methods: One hundred fifty patients with histories of adverse reactions to nonsteroidal anti-inflammatory drugs received ora l challenges with floctafenine; 101 were also challenged with nimesuli de and paracetamol. The oral challenges were administered under single -blinded conditions. One-fourth of the therapeutic dose (floctafenine, 200 mg; nimesulide, 100 mg; and paracetamol, 500 mg) was administered initially; the remaining 3/4 was given one hour later if no symptoms had developed with the initial administration. In patients with histor ies of rhinitis and/or bronchial asthma unrelated to drug use and thos e whose adverse reactions had included bronchospastic or rhinitic symp toms, the FEV(1) was measured. The response to the challenge was consi dered positive if any of the following symptoms developed: erythema, p ruritus accompanied by erythema, urticaria/angioedema, rhinorrhea, nas al obstruction, sneezing dyspnea or cough associated with a decrease o f at least 20% in the FEV(1), hypotension. Results: Floctafenine chall enges were positive in 13/150 patients (8.7%). Nimesulide and paraceta mol provoked reactions in 9/101 patients (8.9%). All positive reaction s occurred within 24 hours of the challenge. None of the patients reac ted to more than one of the drugs tested. Conclusions: Our findings co nfirm those of other investigators regarding the use of nimesulide and paracetamol in patients who do not tolerate aspirin or other nonstero idal anti-inflammatory drugs, although the percentage of reactions to nimesulide observed in the present study is somewhat higher than that reported by some other groups. The study also indicates that floctafen ine, a relatively weak cyclooxygenase inhibitor, can be a valid altern ative for many patients who react adversely to other nonsteroidal anti -inflammatory drugs.