CELEBREX

CELEBREX
Generic: Celecoxib
Manufacturer: Pfizer Inc.
Date Approved: December 1999
Status: Black Box Warning Februray 2005
Approved uses: Arthritis, Muscle pain
Off label uses: Bone pain, Muscle pain, General pain

Serious Side Effects:
Heart attack
Blood clots
Stroke
Bleeding stomach ulcers
Liver damage
Kidney problems

Celebrex, manufactured by Pfizer Inc. was approved for use by the FDA in December of 1999. Celebrex, like Vioxx, Bextra, and Aleve, is a non-steroidal anti-inflammatory drug or NSAID. All of these drugs are part of a new group of NSAIDs referred to as COX-2 inhibitors that greatly increase the risk of cardiovascular complications. These drugs are used to relieve pain associated with arthritis and chronic joint conditions.

Advisory committees examined the use of COX-2 inhibitors at the request of the FDA in February of 2005 to determine the need for stronger warnings, more research, and if the drugs were suitable to stay on the market. As a result, the only two COX-2 inhibitors that remained on the market were Bextra and Celebrex. Bextra was pulled from the market on April 7 that same year due to reports of allergic skin reactions and cardiovascular events. Celebrex is no the only COX-2 inhibitor that remains on the market.

The FDA issued an alert on April 7, 2005 citing that Celebrex is associated with an “increased risk of serious adverse cardiovascular events”. The FDA also requested a package insert warning patients about the increased risk of these cardiovascular events such as heart attack or stroke and potentially life threatening gastrointestinal bleeding.

Common less serious side effects of Celebrex include indigestion, diarrhea, stomach pain, headache, upper respiratory tract infection, sinus inflammation, and nausea. Chances of bleeding stomach ulcers increase the longer a patient takes the drug, and use of Celebrex should be discontinued if a patient experiences burning stomach pain, vomit that has an appearance of blood or coffee grounds, or black bowel movements that look like tar. Liver damage also associated with Celebrex is characterized by vomiting, nausea, loss of appetite, tiredness, yellow coloring of skin or eyes, dark urine, and “flu-like” symptoms.

Contact Keller & Keller LLP for a free consultation and experienced legal advice if you or a loved one has been injured by Celebrex.

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