ABSTRACT
Data from 58 premarketing studies of the nonsteroidal antiinflammatory drug flurbiprofen were pooled for analyses of adverse drug reactions (ADRs). These studies included 5602 patients treated with flurbiprofen (N = 4123), aspirin (N = 1033), or placebo (N = 446) for varying durations. Diagnoses included rheumatoid arthritis, osteoarthritis, and other painful musculoskeletal conditions. In these studies serious upper gastrointestinal ADRs occurred in flurbiprofen-treated patients at less than one half the rate seen in aspirin-treated patients. The incidence of serious urinary tract ADRs was lower with flurbiprofen than with aspirin. The flurbiprofen group had no serious clinical ADRs related to the hemic/lymphatic system. The most common laboratory abnormality was a decrease in hematocrit, which occurred less often than in the aspirin group. We also evaluated serious flurbiprofen-related ADRs in 4370 patients in a variety of other studies and reviewed published reports of flurbiprofen clinical trials and case reports. These reviews showed no additional, unanticipated patterns of intolerance. These clinical safety data indicate that in the doses studied, flurbiprofen is a well tolerated agent for patients requiring nonsteroidal antiinflammatory drug therapy.
Subject(s)
Arthritis, Rheumatoid/drug therapy , Digestive System/drug effects , Flurbiprofen/adverse effects , Osteoarthritis/drug therapy , Urogenital System/drug effects , Adult , Aspirin/adverse effects , Aspirin/therapeutic use , Clinical Trials as Topic , Female , Flurbiprofen/therapeutic use , Hematocrit , Hemoglobin A/analysis , Humans , Male , Middle Aged , Risk FactorsABSTRACT
We assessed the extent of inactivation of L-thyroxin induced by exposure to heat in the presence of two vehicles. Preparations of L-thyroxin in the dry powder form, or dispersed in the solvents propylene glycol (water-like) or ethoxylated castor oil (oil-like), were heated at temperatures ranging from 65 to 160 degrees C, for 5- to 15-min periods. Heating L-thyroxin to a temperature below that of cooked bovine ground meat (72 degrees C) produced less than 10% degradation. Thermal degradation was pronounced only above 90 degrees C, and was almost completed at 160 degrees C. L-Triiodothyronine was the only thermal degradation product identified after L-thyroxin was heated at 125 degrees C. In a separate experiment we measured the melting point of L-thyroxin, 148.81 degrees C. This value agrees closely with the observed thermal sensitivity. We conclude that L-thyroxin is not significantly degraded under conditions encountered during cooking of ground bovine meat for short times at moderate temperatures.
