Ibuprofen and necrotizing fasciitis: "no reason" to suggest link with OTC analgesic -- AHP.

IBUPROFEN AND GROUP A STREP: "NO REASON" TO SUGGEST OTC ANALGESIC LINK in the development of necrotizing fasciitis in children with chicken pox, American Home Products' subsidiary Whitehall-Robins stated in response to reports of several cases of the "flesh-eating bacteria" in the Seattle area. "There is no reason to suggest that either acetaminophen or ibuprofen is related to the disease or its severity," Whitehall said.

Eleven cases of necrotizing fasciitis associated with Group A streptococcal infection involving Seattle-area children with chicken pox have been reported since December 1993, a Seattle-King County Department of Public Health spokesperson said ("The Tan Sheet" Feb. 6, In Brief). In eight of the 11 cases, the children had taken ibuprofen, according to the spokesperson.

American Home Products sent two doctors from its medical staff to Seattle to investigate the reports. AHP said its review of the data revealed that 11 of 12 children (including one case associated with staphylococcal infection) had taken acetaminophen, while only nine of 12 had taken ibuprofen.

Whitehall-Robins, which sells Advil, noted that "given the nature of the [chicken pox], which is characterized by fever and local pain and swelling, it is not surprising that these children would have received a fever reducer or pain reliever such as acetaminophen or ibuprofen."

The Seattle health department has issued an advisory to area physicians cautioning doctors "to limit the use of [NSAIDs] in varicella and particularly where there is suspicion of local complications." The advisory appears in the February issue of the Seattle-King County Department of Public Health's Epi-Log newsletter to physicians.

Doctors at Seattle Children's Hospital are concerned that use of an NSAID "may have impeded granulocyte function and accelerated the disease process" or simply masked the symptoms of the disease, a Seattle-King County Health Department press release states. The advisory says that "there are several case reports in the literature of this association." Noting that in all eight cases the children had received ibuprofen after the infection had set in, a Children's Hospital spokesperson emphasized that the doctors are not concerned with a causal relationship.

AHP is questioning the theoretical basis for the assumed link between ibuprofen and the development of necrotizing fasciitis. The company pointed out that the supposition that NSAIDs impede granulocyte function is largely based on in vitro studies which may not be predictive of clinical experience. AHP said there also are data showing that acetaminophen can diminish white blood cell function. Although a 1985 British Medical Journal article reported on 31 cases of necrotizing fasciitis and that six of the cases involved use of an NSAID, AHP pointed out that none of the cases involved ibuprofen.

Regarding the possibility that ibuprofen may mask the symptoms of necrotizing fasciitis, AHP Senior VP-Scientific Affairs Roger Berlin, MD, observed that the occurrence of such infections in children with chicken pox is rare. To restrict use of the drug to prevent such cases, he said, would be tantamount to "therapeutic nihilism."

FDA has not released a statement on the issue except to say that the agency approved ibuprofen for over-the-counter use and that it believes the drug is safe and effective when used according to the directions on the label. Noting that the Seattle case results are too preliminary to make any statement regarding an association between necrotizing fasciitis and NSAIDs, the Centers for Disease Control & Prevention said it is investigating Group A strep.