In a vote that expressed strong disagreement over the long-term consequences, an FDA panel has recommended that Pfizer be allowed to market painkiller Celebrex for treatment of children two and older with juvenile rheumatoid arthritis. The fifteen-member advisory board ruled that for short-term use, the benefits of the drug outweighed its risks, despite concerns over past cardiovascular problems caused by sister drugs like Vioxx. However, in a separate 8-7 decision, it found that Pfizer had not proven that Celebrex could be safely used with children. Panel members are strongly suggesting that the long-term safety of the drug be studied, perhaps by tracking the health of a registry of individual patients.
Fore more information on the decision:
- read this Associated Press piece [1]
Related Articles:
Despite risks, Pfizer seeks Celebrex use for kids. Report [2]
New warning on Celebrex. Report [3]
Celebrex linked to heart attack risk. Report [4]
Links:
[1] http://www.nytimes.com/2006/11/30/health/30fda.html?_r=1&ref=health&oref=slogin
[2] http://www.fiercehealthcare.com/story/despite-risks-pfizer-seeks-celebrex-use-for-kids/2006-11-27
[3] http://www.fiercebiotech.com/story/regulators-add-warning-to-bextra-allow-new-indication/2005-08-02
[4] http://www.fiercebiotech.com/story/spotlight-celebrex-linked-to-heart-attack-risk/2006-03-01