The drug is already indicated for adults with rheumatoid arthritis. Celebrex is a medication which is part of a class of drugs known as COX-2 inhibitors. COX-2 inhibitors, such as Merck & Co.’s Vioxx, were withdrawn from the market after reports linked them to heart attack and stroke risk. Celebrex is the only drug of this type still being marketed.
A committee of doctors and other specialists voted 15-1 to approve the expanded use of Celebrex in children. The FDA reviewed the drug and decided it was not completely safe but its effectiveness outweighed any risks caused by the treatment. As part of the approval, Pfizer has agreed to conduct two phase IIII post-marketing studies to evaluate the safety risks of the drug in more detail.