FDA Panel Recommends Approval of Celebrex for Children

In yet another controversial move, an advisory panel of the U.S. Food and Drug Administration (FDA) voted to recommend approval of <"http://www.yourlawyer.com/topics/overview/celebrex">Celebrex for the treatment of juvenile rheumatoid arthritis (JRA). The recommendation comes despite a number of lingering long-term safety concerns associated with the drug, which is manufactured by Pfizer.

Approximately 60,000 children are afflicted with JRA in the United States. Fifteen of the 16 panel members voted for approval, citing the short-term benefits of Celebrex and the lack of evidence of short-term safety issues. However, in an 8-7 vote (with one abstention), the panel confirmed that the drug’s long-term safety could not be assured and they urged Pfizer to conduct long-term studies in order to prove its ultimate safety.

Medical experts and consumer watchdogs immediately challenged the decision. According to Howard Coleman, CEO of Seattle’s Genelex Corporation, “Thousands of children have an inability to process Celebrex safely.” (Genelex conducts DNA testing in order to determine the safety of drugs and supplements.) Those children who cannot process the drug appropriately may build up dangerous levels of the drug in their bloodstreams.

Celebrex is a COX2 inhibitor, in the same class as Vioxx and Bextra–both of which were outlawed by the FDA due to risk of heart attack or stroke. Pfizer is asking the FDA to expand its approved usage of Celebrex to include minors suffering from JRA, a painful ailment affecting joints and potentially impeding growth and development. According to some reports, roughly 10 percent of all juvenile rheumatoid arthritis patients are already prescribed Celebrex “off-label”–meaning that the FDA has not approved its usage.

In a related story, a study published in this month’s Federation of American Societies for Experimental Biology (FASEB) Journal investigates the issue of why COX2 inhibitors “increase the risk of myocardial infarction and stroke.” Researchers believe that COX2 inhibitors also inhibit the production of the COX1 enzyme, which is essential to blood-thinning capability and helps prevent the onset of clotting.

This entry was posted in Health Concerns, Legal News. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.