Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US federal regulators have decided that Pfizer should be allowed to market Celebrex for children despite identifying some risks with the arthritis drug.
Subscribe to our email newsletter
In an 8-7 vote, with one abstention, panel members said that available data did not demonstrate that Celebrex was safe in treating the disease.
However, the regulators decided that the benefits outweighed the risks for treatment with juvenile rheumatoid arthritis. The FDA will review the advisors judgement on the drug and decide whether to expand the indication for Celebrex. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.
Celebrex is a member of a class of drugs that have recently come under intense scrutiny for causing cardiovascular side effects. The drugs called Cox-2 inhibitors have all been withdrawn from the market except for Celebrex.
The panel suggested that the long-term effects of the drug should be analyzed.