Celebrex is an anti-inflammatory drug used to treat rheumatoid arthritis and osteoporosis, approved by the U.S. Food and Drug Administration (FDA) in 1998. The FDA issued a number of restrictions on the drug beginning in 1999 due to complaints about serious side effects, including chest congestion; flu-like symptoms; high blood pressure; stroke; and various heart problems, include heart attack. Less sever, but more common side effects include headache, nausea, indigestion, and diarrhea.
The drug's manufacturer, Pfizer, settled with plaintiffs for hundreds of millions of dollars in 2008, while additional lawsuits continue to be filed. The following is an overview of Celebrex and its liability for patients' injuries. See Celebrex FAQ and Celebrex Links for more information.
Celebrex Drug Facts
Celebrex is the brand name of the generic drug celecoxib, first approved by the FDA for the treatment of rheumatoid arthritis and osteoarthritis. One year later, it was approved as a treatment for patients with a rare genetic disorder called familial adenomatous polyposis (FAP), which always develops into colon cancer if left untreated. Celebrex is a non-steroidal anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as "Cox-2 inhibitors."
Although steroids are considered safe for brief use to reduce inflammation, when taken for longer periods, they can cause serious side effects. Consequently, NSAIDs are preferred for the reduction of inflammation if steroids can be avoided.
Celebrex prevents the formation of certain prostaglandins ("Cox-2") believed to cause pain and inflammation, as well as prevent blood cells from sticking together. Unlike other NSAIDs, Celebrex does not also block a second enzyme called "Cox-1," which protects the stomach lining. Celebrex it touted as being able to reduce pain and inflammation without also causing ulcers and gastrointestinal bleeding.
The Safety Concerns of Celebrex
Since the FDA approval of Celebrex, health concerns have been raised regarding its use. In April 1999, for instance, the Wall Street Journal reported that the manufacturer of Celebrex (Pharmacia, later acquired by Pfizer) had recently submitted adverse events reports (AER) to the FDA, linking 10 deaths and 11 cases of gastrointestinal (GI) bleeding to the use of Celebrex. This resulted in a rapid decrease in sales.
However, further research led to another article that admitted several doctors who evaluated the AERs on Celebrex could find no evidence to suggest that the drug was solely responsible for the deaths. In addition, more information about the histories of the victims was released. Of the ten deaths, it was reported that eight of the individuals had prior histories of heart, liver, or gastrointestinal problems.
These explanations resulted in restored faith in the safety of Celebrex, and sales began to climb again. But at about the same time, the FDA had started receiving reports of "bleeding events" by patients taking Celebrex with Coumadin (generic name warfarin), a blood thinner used to reduce blood clots. The FDA required the manufacturer to include a warning on its promotional materials.
Filing a Lawsuit for Celebrex Injuries
If you have experienced serious side effects from the use of Celebrex or related NSAIDs, you may be able to file a product liability claim and/or a medical malpractice claim (if improperly prescribed). The FDA acknowledges the following risks associated with Celebrex and similar drugs:
- Heart attack
- Ulcers and/or stomach/intestine bleeding
- Kidney and/or liver failure
- Serious skin rashes and other allergic reactions
In determining whether you have a valid claim, you must prove that you were injured and that Celebrex was the cause of your injuries. You also need proof that Celebrex causes unreasonably dangerous side effects, which the FDA already has acknowledged. For a malpractice claim, you would have to prove that the doctor, pharmacy, or other responsible party failed to properly prescribe the drug.
You have a limited time in which to file your lawsuit ("statute of limitations"), which varies by state. Keep in mind that many states have capped damages for malpractice claims. Additionally, there have been numerous class-action lawsuits against Pfizer related to the use of Celebrex. Talk to a products liability lawyer if you have additional questions or believe you may have a claim.
Who Should Not Take Celebrex
According to Pfizer, patients should not take Celebrex if they have aspirin-sensitive asthma, or allergic reactions to aspirin or other arthritis medicinesor certain sulfa drugs called sulfonamides, or if they are in their third trimester of pregnancy.
Special Warnings with Celebrex
Celebrex and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get:
- A burning stomach pain;
- Black bowel movements that look like tar;
- Vomit that looks like blood or coffee grounds.
Celebrex and other NSAID medicines can cause serious allergic reactions that include swelling of the face, lips, tongue or throat. These allergic reactions may cause problems with breathing, swallowing, and wheezing. Serious allergic skin reactions have also been reported with the use of NSAIDs. If you experience any of these symptoms, contact a physician immediately.
See Safety and Celebrex for Pfizer's warnings.