Healthy Skepticism Library item: 13332

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Ahead of the Bell: Celebrex Review
Associated Press 2008 Mar 25
http://biz.yahoo.com/ap/080325/ahead_of_the_bell_celebrex.html?.v=1

Full text:

FDA Advisers Will Review Safety of Pfizer’s Celebrex and Other Drugs in Children

WASHINGTON (AP) — A group of government experts on Tuesday will review the safety of a handful of drugs when used in children.

The Food and Drug Administration’s panel of pediatricians will discuss adverse reactions reported with eight drugs, including Pfizer Inc.‘s blockbuster painkiller Celebrex. FDA is required to review safety data on drugs approved under its pediatric exclusivity program, which awards companies a six-month patent extension on a drug if they test it in children.

FDA will present safety data on Pfizer’s Celebrex, which was approved in 2006 to treat rheumatoid arthritis in children.

According to documents released ahead of the meeting, FDA has received 10 reports of adverse reactions with Celebrex among children, including two deaths. FDA scientists concluded the cases “did not reveal any notable unexpected safety concerns,” with Celebrex.

The committee will also review safety data on drugs from Sanofi-Aventis SA, Astrazeneca Plc and others.