Celebrex Litigation at The Lanier Law Firm
Celebrex (Celecoxib) was approved by the Food and Drug Administration (FDA) in 1998. Similar to Vioxx (Rofecoxib), Celebrex is a Cox-2 inhibitor designed to treat and manage osteoarthritis, menstrual pain, and other acute pain in adults.
In the wake of Merck's withdrawal of Vioxx in September 2004, questions arose about whether similar Cox-2 inhibitors, such as Celebrex, were linked to cardiovascular injuries. As a result, in February, 2005, the FDA asked an advisory committee to examine Cox-2 inhibitors and to determine whether the drugs offer enough benefits to stay on the market. Additionally, the FDA inquired whether Cox-2 inhibitors needed stronger warnings and what further research was needed on the drugs.
The advisory committee met February 16-18, 2005. During the hearings, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the FDA panel that studies "strongly suggested" that the entire class of drugs called Cox-2 inhibitors elevated the chances of cardiovascular problems. Dr. Garret Fitzgerald, a top scientist and Cox-2 researcher at the University of Pennsylvania, also told the U.S. regulatory panel that all pain drugs in the class known as Cox-2 inhibitors create an imbalance in the body's cardiovascular system that leads to an increased risk of heart attacks and strokes.
The hearings concluded and Celebrex was allowed to stay on the market, making it the last Cox-2 inhibitor to remain on the U.S. market (a similar medicine, Bextra, was pulled from the market). However, the FDA requested that the label for Celebrex (also manufactured by Pfizer) be revised to include a "Black Box" warning to highlight the potential increased risk of cardiovascular events and potentially life-threatening stomach bleeding.
Celebrex Information Links:
"Arthritis Drug Celebrex Linked to Higher Heart Risk", CBC News, December 19, 2004
2005 FDA Cox-2 Public Health Advisory
2005 FDA Cox-2 Drug Information Page
