Manufacturer: Pfizer, Inc.
Date approved: 1998
Status: Prescription only
Approved uses: Treating symptoms of osteoarthritis and rheumatoid arthritis and other arthritis. Easing painful menstrual cramps. Relief from acute pain for adults.
Off-Label uses: Cancer prevention, pain relief, psychiatric applications
• Increased risk of cardiovascular incidents including blood clotting, heart attack and stroke
• Kidney Problems
• Fluid Retention
• Liver Damage
• Potentially Lethal Stomach Bleeding
Celebrex Lawsuit Information – Contact a Celebrex Lawsuit Attorney
Celebrex, or Celecoxib, is an anti-inflammatory drug manufactured by Pfizer. Celebrex is used to treat the symptoms of osteoarthritis and rheumatoid arthritis, and alleviate severe menstrual cramps and other acute pain. The FDA has requested Pfizer include in the drug’s packaging a warning about the increased risk of serious cardiovascular incidents, including blood clots, heart attack and stroke related to taking Celebrex. Other serious Celebrex side effects include fluid retention, kidney problems, liver damage and potentially life-threatening stomach bleeding.
Celebrex – Serious Health Effects Still Exist
Celebrex (celecoxib) is a prescription medication in a class of drugs called COX-2 non-steroidal anti-inflammatory drugs (NSAIDs) manufactured by Pfizer, Inc. On July 29, 2005, at the request of the Federal Food and Drug Administration (FDA), Pfizer, Inc. added a black box warning to the Celebrex label due to Celebrex side effects. The warning includes information on the increased risk of cardiovascular (CV) thrombotic events, the contraindications for treatment of perioperative pain for coronary artery bypass graft (CABG) surgeries and the increased risks of gastrointestinal events. The labeling also contains safety data from long-term treatment trials with celecoxib.
Currently Celebrex is the only COX-2 inhibitor to remain on the market. The two other COX-2 medications were Bextra, also manufactured by Pfizer, Inc., and Vioxx, which was manufactured by Merck Pharmaceuticals. They were both removed from the market in 2005. Potential side effects and other serious health concerns still exist with the use of Celebrex and sales of the drug have been cut in half, to $1.7 billion in 2005 from $3.3 billion in 2004. More than 26 million people have taken the drug since it was brought to market in 1998.
After a number of meetings in 2005, the FDA concluded that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients. Accordingly, the FDA has allowed Celebrex to remain on the market and asked Pfizer Inc. to take the following actions:
• Revise the Celebrex label to include a boxed warning containing the class NSAID warnings and contraindication.
• Encourage doctors to discuss with patients the potential benefits and risks and other treatment options before a decision to use Celebrex.
• Include a Medication Guide as part of the labeling.
• Commit to conduct a long-term study to address the safety of Celebrex compared to naproxen and other appropriate drugs.
The FDA is working with Pfizer, other manufacturers and interested stakeholders to design the long-term study and to ensure its timely initiation and completion. Long-term controlled clinical trials have not been conducted with most NSAIDs. Currently it is very difficult to draw conclusions about adverse effects with the data available. All manufacturers of NSAIDs must submit to the FDA a comprehensive review and analysis of available controlled clinical trial databases pertaining to their product(s) to which they have access to further evaluate the potential for increased CV risk.
In August 2005, the FDA finalized the “black box” warning for Celebrex. In February 2006, the first Celebrex lawsuit was filed by a stroke survivor against Pfizer Inc. The case has been set for trial in June 2006 at a Circuit Court in Alabama. Since Bextra and Vioxx were removed from the market, nearly 10,000 lawsuits have been filed against Merck Pharmaceuticals by former Vioxx patients and their families.
Any individual that believes they may have been harmed or suffered adverse heath effects from the usage of Celebrex should seek the advice of an attorney who specializes in pharmaceutical litigation.
The Dangerous Side Effects of a Popular Arthritis Medication — Celebrex
Celebrex is a prescription medication in a class of drugs called COX-2 non-steroidal anti-inflammatory drugs (NSAIDs). It is in the same class as Bextra and Vioxx. Celebrex is developed and manufactured by Pfizer, Inc., a global pharmaceutical company that manufactures many well known and widely used prescription and over the counter medications, including household names such as Listerine, Neosporin, Sudafed, Visine, Viagra and others.
Celebrex was originally approved in December 1998 to treat the pain of osteoarthritis and rheumatoid arthritis. It is also used to treat the symptoms of severe menstrual pain in some women, as well as ankylosing spondylitis (a painful, progressive, rheumatic disease that mainly affects the spine but can also affect other joints, tendons and ligaments). Additionally, Celebrex may be used to treat acute pain and has been associated with the reduction of colorectal polyps.
While NSAIDs are very effective at treating the painful symptoms of the aforementioned illnesses, the use of COX-2 drugs, including Celebrex, is associated in some patients with serious problems from stomach ulcers, including internal bleeding, and with liver damage. Perhaps more importantly, Celebrex and other drugs in its class have been closely linked with an increase in cardiovascular events, including heart attack, blood clots and stroke.
Controversy over this class of drug started with the voluntary recall of Vioxx by its manufacturer in September 2004, after it was determined that the drug almost doubled the risk of some cardiovascular events in certain patients. This led the FDA and others to take a closer look at the possible adverse side effects of the entire class of drugs. The side effects include:
• Kidney and heart failure.
• Aggravation of hypertension.
• Chest pain.
• Ringing in the ears.
• Stomach and intestinal ulcers.
• Blurred vision.
• Weight gain.
• Water retention.
• Flu-like symptoms.
On July 29, 2005, Pfizer Inc. added a black box warning to the Celebrex label. The new black box warnings include:
• Increased risk of cardiovascular (CV) thrombotic events, including myocardial infarction and stroke.
• Contraindication for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Increased risk of gastrointestinal events such as bleeding, ulceration, and perforation of the stomach or intestines
Currently, Pfizer’s Celebrex (celecoxib) is the only Cox-2 inhibitor NSAID to survive the recent FDA scrutiny and to remain on the market. However, the potential side effects and other serious health concerns still exist.