Celebrex is an anti-inflammatory drug which is used to treat rheumatoid arthritis and osteoporosis. It has been granted approval from the US Food and Drug Administration in 1998. However, FDA has issued some restrictions on the drug since 1999 because of the reports and complaints about severe side effects, including chest congestion, symptoms of flu, hypertension, stroke, and other heart problems such as heart attack. Less severe side effects include headaches, indigestion, diarrhea, and nausea.
Pfizer, the manufacturer, has settled with plaintiffs for hundreds of millions of dollars in 2008 and additional cases continue to be filed. The following is an overview of Celebrex and its liability for patients’ injuries.
Facts about Celebrex Drug
Celebrex is the brand name of the generic drug celecoxib, which was first granted its approval by the US FDA for medication of rheumatoid arthritis and osteoarthritis. After one year of its approval, it was given another approval for treatment of an uncommon genetic disorder called familial adenomatous polyposis or FAP which develops into colon cancer if it is not treated immediately. Celebrex is a non-steroidal anti-inflammatory drug or NSAID and belongs to the class of drugs referred to as “Cox-2 inhibitors.”
While steroids are considered safe for temporary treatment to reduce inflammation, if it is taken for a longer duration, they can cause severe side effects. Generally, NSAID is chosen to reduce inflammation if steroids can be avoided.
Celebrex has the ability to prevent the formation of some prostaglandins or Cox-2 which is believed that can cause pain and inflammation and prevents blood cells from clotting. Unlike other NSAIDs, Celebrex does not stop a second enzyme call “Cox-1”, which safeguards the stomach lining. Celebrex is known to have the ability to reduce pain and inflammation without resulting in ulcers and gastrointestinal bleeding.
Other Cox-2 inhibitors are Vioxx and Bextra were removed from the market in 2004 and 2005.
The Safety Considerations of Celebrex
Since the FDA approval of Celebrex, there are health concerns that have been presented about its use and application. For example, in April 1999, the Wall Street Journal has reported that the producer of Celebrex, the Pharmacia which was later acquired by Pfizer, submitted its adverse events reports or AER to FDA, connecting ten fatal deaths and eleven gastrointestinal bleeding (GI) cases due to the use of Celebrex. This causes rapid fall in its sales.
However, further research has led to another article that admitted that there were doctors who assessed the AERs on Celebrex who found no evidence to link the drug as the only contributory factor for the deaths. More information about the histories of the victims was released and of the ten deaths, it was reported that eight of them has previous histories of heart, liver, and gastrointestinal problems.
These explanations have brought back the trust in the safety of Celebrex and sales started to rise again. But about the same time, FDA began receiving reports again of “bleeding events” by the patients who are using Celebrex with Coumadin, with the generic name of warfarin, which is a blood thinner used to lessen blood clots. FDA asked the manufacturer to include a warning notice on its promotional materials.
Factors for Filing a Lawsuit for Celebrex Injuries
If you are experiencing severe side effects from using Celebrex or related NSAIDs, you can file a product liability claim and/or a medical malpractice claim, if the drugs are improperly prescribed. The FDA warns of the following risks that are known to be related to Celebrex and similar drugs:
- Heart attack
- Kidney and/or liver failure
- Ulcers and/or stomach/intestine bleeding
- Severe skin rashes and other allergic reactions
To know whether you have a valid issue, you have to prove that you were injured due to the use of Celebrex or other similar drugs. You will need valid proof that Celebrex causes severe side effects which the FDA had already acknowledged and warned. For malpractice claim, you need to prove that the doctor, pharmacy, or other professional failed to properly prescribe the drug to you.
You will have restricted time to file your claim, as stipulated at the “statute of limitations,” which will differ from one state to another. Remember that many states have capped damages for malpractice claims. Furthermore, there were many class-action lawsuits against Pfizer associated with the use of Celebrex. Discuss with an experienced product liability attorney if you have more questions or if you believe you have a valid claim.
Who Should Not Take Celebrex
Pfizer identified that patients must not take Celebrex if they have aspirin-sensitive asthma, or allergic reactions to aspirin, or other arthritis drugs or some sulfa drugs known as sulfonamides, or if they are in their third trimester of pregnancy.
Some Special Warnings Against Celebrex
Celebrex and other NSAID drugs can cause stomach ulcers that can lead to bleeding. The risks of this severe problem increase when you use Celebrex longer and with higher doses of Celebrex. Stomach bleeding can also occur during your treatment with Celebrex. Stop using Celebrex immediately and call your doctor or healthcare professional if you have:
- Black bowel movements that appear like tar;
- Vomiting that looks like blood or coffee grounds; and
- Burning stomach ache.
Celebrex and other NSAID drugs can lead to severe allergic reactions, including swelling of the face, tongue, lips, or throat. These allergic reactions can also cause problems with breathing, wheezing, and swallowing. More severe allergic skin reactions have been reported with those who use NSAIDs. If you are experiencing these symptoms, contact a doctor immediately!