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| |  Side Effects From Advil Treatment Comparable To Placebo MADISON, NJ -- May 25, 1999 -- A new analysis has reconfirmed the safety of Whitehall-Robins Healthcare’s non-prescription Advil(R) (ibuprofen), illustrating that the overall frequency of patient-reported side effects was comparable to a placebo treatment. The analysis examined the safety of multiple-dose use of Advil in eight independent controlled clinical trials. This study is being reported at the International Conference on Inflammopharmacology in Braselton, GA., this week and has been published in this month’s issue of the Journal of Clinical Pharmacology. The analysis included studies conducted over a period of five years and totalling 2,187 patients. The data revealed that patients who took placebo actually reported side effects significantly more often than those taking Advil (Advil 27 percent, placebo 32 percent). In fact, the side effect frequency among ibuprofen-treated subjects was lower than placebo-treated subjects, probably due to ibuprofen's beneficial effect on various painful conditions like headache. Most noteworthy, in the digestive tract, the frequency of reported side effects was comparable for ibuprofen (12 percent and placebo 11 percent). "An important message of these data is that, when taken as directed in multiple doses, non-prescription ibuprofen is extremely safe," said David Kellstein, Ph.D., assistant director, clinical research, at Whitehall-Robins and lead author of the study. "Our findings illustrate the low frequency of side effects for Advil in all categories, including the gastrointestinal tract. These results further support the favourable overall and gastrointestinal safety profiles of Advil." The new data are also consistent with the safety profile previously established for prescription-strength ibuprofen. Epidemiologic investigations, endoscopic studies and analyses of spontaneously-reported side-effects consistently show prescription ibuprofen to be among the safest of NSAIDs. This excellent safety profile of ibuprofen is further enhanced in OTC use due to the lower dose and shorter duration of use. The analysis compiled studies where participants took from one to ten days of ibuprofen, with doses ranging from 800mg/day up to non-prescription maximum of 1,200mg/day. This meta-analysis, funded by Whitehall-Robins, included studies of osteoarthritis pain, delayed-onset muscle soreness, sore throat, dental pain and an examination of the tolerability of maximum OTC doses of ibuprofen. Each study was randomised, double-blind, placebo-controlled and parallel-group and involved participants who were 12 years of age or older. Side effects were classified according to U.S. Food and Drug Administration terminology. Of note, there were no serious side effects in any of the 2,187 study participants. Advil Tablets, Caplets, Gel Caplets and Liqui-Gels are indicated for the relief of aches and pains associated with common cold, headache, toothache, muscular aches, backache, minor pain of arthritis and menstrual cramps. All Advil products are also indicated for the temporary reduction of fever. Related Links: Advil, Whitehall-Robins Healthcare
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