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Pennsylvania Celebrex Lawyers

Celebrex

Never discontinue taking any medication without first consulting with your physician.

Update 10/20/08: "Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world's biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm." (via www.cbsnews.com)

Celebrex®
In April 2005 the Food and Drug Administration ordered Pfizer, Inc. to include a strongly worded boxed warning about the cardiovascular and gastrointestinal risks associated with Celebrex. The label encourages prescribers to discuss potential benefits and risks of Celebrex before the patient agrees to use the drug. Additionally, the lowest effective dose for the shortest duration is recommended, as is the inclusion of a Medication Guide (also highlighting CV and GI risks associated with Celebrex).

FDA ALERT-[4/7/2005]: Celebrex has been linked to an increased risk of serious cardiovascular (CV) events (such as heart attack or stroke) which appears to be a risk shared by all medicines called non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). FDA has requested that the package insert (labeling) for all NSAIDs, including Celebrex, be revised to include a “boxed” or serious warning to highlight the potential increased risk of CV events, and the well known risk of serious, and potentially life-threatening, stomach bleeding. FDA has also requested that the package insert for all NSAIDs be revised to state that patients who have just had heart surgery should not take these medicines.

Celebrex was approved for use by the FDA in 1998 and has since become the most prescribed drug in its class, with 23.9 million prescriptions written in 2004 (2). It is prescribed primarily as a pain reliever for arthritis and other conditions. However, in December 2004, the safety of this popular drug came into question when the National Cancer Institute halted a Celebrex trial because of an increased risk of cardiovascular events. For patients taking high daily doses of Celebrex, the risk was more than doubled and, with some dosages, more than tripled. Pfizer, Inc., its manufacturer, says that this is the first Celebrex study to find such risks, and thus, it has no current plans to remove the drug from the market.

What are COX-2 selective inhibitor drugs?
Celebrex—and also Vioxx®, a similar drug now withdrawn from the market—are both members of a class of drugs called COX-2 selective inhibitors. They were developed as an alternative to traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen.

NSAIDs work by blocking COX-2 enzyme in the body, which reduces swelling and associated pain; however, they also block the COX-1, which involves digestion in the gastrointestinal tract. This often causes serious GI side effects, including ulcers, burns and bleeding in the stomach lining. COX-2 selective inhibitors, however, block the inflammation-causing COX-2 enzyme only, an action that, theoretically, should preserve all of the NSAID benefits while eliminating the gastrointestinal side effects.

What dangers are associated with Celebrex?
Questions about COX-2 drugs and their relative benefits and risks began to emerge at an FDA panel discussion in February 2001. At that meeting, two different manufacturer-funded studies were presented—one on Vioxx and one on Celebrex—both intended to demonstrate the drugs’ positive GI effects. However, neither one of the studies supported a significant GI benefit of these drugs over their older, cheaper traditional NSAID counterparts—one of the chief selling points of the drugs. Within a year, the FDA had ruled that Celebrex could no longer be marketed as a safer alternative to traditional NSAIDs.

Almost four years later when, in the wake of the Vioxx withdrawal and emerging questions about the safety of the COX-2 drug class as a whole, new concerns about Celebrex were suddenly revealed in December 2004. Preliminary data from a National Cancer Institute study designed to study the long-term effects of Celebrex on the prevention of colon polyps suggests that daily use of high-dose Celebrex may be responsible for an increased risk of cardiovascular events. For those taking 400 mg. the risk was a 2.5-fold increase over placebo; for those taking 800 mg. a 3.4 fold increase (3).

However, two other Celebrex studies similar in size and duration, another cancer-prevention trial and an Alzheimer’s prevention trial, have not yet shown an increased risk of cardiovascular events.

According to the FDA and the drug labeling, the cardiovascular risks associated with Celebrex use may include:

• Heart attack
• Stroke
• Blood clots, including those in the legs (deep vein thrombosis) and the lungs (pulmonary embolism)
• Cardiovascular death
  

What actions are being taken to protect consumers?
Even though Pfizer, Inc. has no current plans to withdraw Celebrex from the market, the FDA ordered the drug manufacturer to include a strongly worded boxed warning about the cardiovascular and gastrointestinal risks associated with Celebrex. Almost immediately after the study data was revealed, the FDA requested that all direct to consumer advertising of Celebrex be halted (4). In that same statement, the FDA also encouraged “physicians to consider alternative therapies as they evaluate their individual patient needs.”

Public Citizen, a consumer watchdog group, has called for the withdrawal of remaining drugs in the COX-2 class, which includes Celebrex, because of cardiovascular risks. In a Dec. 17, 2004, press release on www.citizen.org, they cite their early warnings to patients to not use these drugs in the presence of safer alternatives.

What if my doctor just switched me to Celebrex?
You are not alone. After the withdrawal of Vioxx from the market, prescriptions of Celebrex, already the best-selling drug in its class, escalated. And no wonder. On the day of Vioxx’s withdrawal, September 30, 2004, Pfizer issued a statement in response, with Dr. Joe Feczko, Pfizer’s president of worldwide development saying, “Pfizer is confident in the long-term cardiovascular safety of Celebrex,” and suggested it as a recommended alternative. However, in light of the new data, anyone taking Celebrex should consult their doctor anew to discuss the FDA April 2005 Public Health Advisory and again weigh the risks versus the benefits specific to their own patient history.

Does the safety data apply to the entire COX-2 inhibitor class?
No drug is completely safe, and the FDA is continuing to evaluate whether or not the cardiovascular risks exhibited by the Celebrex study apply to the COX-2 class as a whole. That said, in light of the troubling data that has emerged about all three of the drugs in this class and the removal of both Bextra and Vioxx from the market, patient concern is understandable. People who are taking Celebrex or similar medications should educate themselves on the information and consult with their physicians to evaluate their individual risks.

What should I do if I am taking or have taken Celebrex?
Never discontinue taking any medication without first consulting with your prescribing physician. However, if you or someone you know is taking Celebrex and is concerned about the possible risks to their health, consult with a physician to discuss viable alternatives to this medication. And if you or someone you know has experienced a serious cardiovascular event while taking Celebrex, we would like to help.

Sources:

1. “FDA Public Health Advisory,” www.fda.gov/cder 7 April 2005, accessed April 8 2005.
   
   
2. “Bextra Ban good, but Celebrex should be next,” www.citizen.org/pressroom 7 April, 2005, accessed April 8 2005.
   
   
3. “FDA Alert for Practitioners on Celebrex,” www.fda.gov/cder 17 Dec. 2004, accessed 21 Dec. 2004.
   
   
4. “FDA Statement on Celebrex DTC Promotion,” www.fda.gov 20 Dec. 2004, accessed 21 Dec. 2004
   

Never discontinue taking any medication without first consulting with your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Celebrex® and Bextra® are registered trademarks of Pfizer, Inc. and are used here only for the purpose of identifying the products in question.

Vioxx® is a registered trademark of Merck & Co., Inc. and is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Pfizer, Inc, Merck & Co., Inc., the FDA, the National Cancer Institute, or Public Citizen.

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