CELEBREX

The Cartwright Law Firm was one of the first law firms in the country to evaluate Celebrex and Vioxx injury cases beginning in July 2001. We are currently evaluating potential claims of individuals who have taken Celebrex (celecoxib) and have been diagnosed with a heart attack or stroke while taking that medication. If you or a loved one have taken Celebrex and have suffered from a heart attack or stroke, please call immediately for a free, confidential consultation with one of our firm’s attorneys.

Manufactured by the world’s largest pharmaceutical company, Pfizer, Inc., and approved by the U.S. Food and Drug Administration (FDA) on December 31, 1998, Celebrex was the first Cox-2 Selective Non-Steroidal Anti-Inflammatory Drug (NSAID) to go on the market.

Celebrex, also known as Celecoxib, is approved for the treatment of osteoarthritis (arthritis caused by age-related “wear and tear” on bones and joints), rheumatoid arthritis in adults, acute pain in adults (like the short term pain a dental or surgical patient may experience following an operation), painful menstrual cycles, and for the reduction of colorectal polyps. In the United States the recommended doses of Celebrex are 100mg to 200mg per day for osteoarthritis, 200mg to 400mg per day for rheumatoid arthritis, and in doses up to 800mg per day for Familial Adenomatous Polypsis.

As the first Cox-2 Selective NSAID to debut on the pharmaceutical market, Celebrex made headlines and was believed to provide a valuable alternative to traditional, non-selective NSAID therapies, such as Ibuprofen (including brand name products Advil and Motrin), Naproxen (including brand name products Aleve, Naprosyn and Naproxyn), Diclofenac and Nabumetone. These traditional NSAID medications worked to eliminate pain by inhibiting the production of two enzymes in the body. The Cox-2 enzyme has been identified as an enzyme that causes inflammation and pain in arthritis sufferers. The Cox-1 enzyme acts to protect the lining of the stomach. The traditional NSAID medications eliminate both the Cox-1 (stomach protective) and the Cox-2 (inflammation/pain causing) enzymes. While these older pain relievers do contribute to pain relief by inhibiting the enzyme that contributes to pain, they also tend to cause gastro-intestinal problems such as bleeding, ulcers and perforations because they also inhibit the Cox-1, stomach-protecting enzyme. Pfizer alleges that Celebrex isolates and inhibits only the Cox-2 (inflammation/pain causing) enzyme, without inhibiting the stomach protecting Cox-2 enzyme. Therefore, because of its selectivity, Celebrex was purported to offer significant pain relief without the accompanying gastrointestinal problems that the older, traditional NSAIDs could so frequently cause. Recent studies do not support Pfizer’s claim.

Pfizer spent considerable resources on the promotion of its new product to physicians and on “direct-to-consumer” advertising. These initial promotional activities for physicians and direct to consumer advertisements mentioned nothing about potential cardiovascular risks known by Pfizer, nor did the actual package insert that accompanied the Celebrex prescription that users would receive from their pharmacies. On February 1, 2001 the FDA sent a “Warning Letter” to the president and CEO of Pharmacia (now owned by Pfizer) stating that the promotional activities and materials for the marketing of Celebrex are false, lacking in fair balance, or otherwise misleading in violation of FDA regulations. Specifically, the FDA was concerned with minimization of potentially dangerous bleeding events that could occur for Celebrex users who were also taking Coumadin (a blood thinning medication). Also, the FDA was concerned with “unsubstantiated comparative claims” made regarding the safety and efficacy of Celebrex as compared to its competitor Vioxx. Such unsubstantiated comparative claims were said to be false and misleading because no substantial evidence existed that proved Celebrex to be safer than Vioxx.

Following the release of new clinical trial results, on December 17, 2004 the FDA requested Pfizer, Inc. to voluntarily suspend its direct-to-consumer advertising on Celebrex until the agency was able to obtain and evaluate this new scientific data regarding adverse events (heart attack, stroke) associated with Celebrex. At this time, again, the drug company was asked to change the information provided to physicians to reflect FDA recommendations encouraging physicians to consider alternative therapies in light of individual patient needs. Pfizer agreed to comply with this FDA request, suspending its Celebrex direct-to-consumer advertising on television, radio, newspapers and magazines and crafting more appropriate detailing to physicians reflecting the uncertainty of scientific data currently available regarding product safety.

This new information came from the experiences of 3,600 patients in a five-year cancer study who were taking either 400mg to 800mg of Celebrex per day or placebos, according to a Pfizer news release. Compared with the placebo users, the risk of heart trouble was 2.5 times greater for patients taking 400mg of Celebrex per day, and 3.4 times greater for patients taking 800mg per day.

It is noteworthy that while Pfizer’s biggest competitor, Vioxx (manufactured by Merck & Co.), was pulled from the market due to safety concerns just two months prior to the release of this Celebrex study information, during the time that revelations were made public concerning the safety problems with Vioxx, Pfizer had issued statements affirming that Celebrex was safe. A physician with Harvard University’s medical school, John Abramson, stated that these new revelations highlight the conflict of interest that exists when drug companies fund the safety tests of their own products. Abramson stated that Celebrex “wasn’t a wonder drug. It was wonder marketing.” He emphasized the importance of having people with no financial connection to oversee the safety of our drugs.

Dr. Abramson advised patients to speak with their physicians, but to understand that giving up Celebrex as their pain medication is not necessarily giving up the best medication available to them. He indicated that over-the-counter drugs could likely provide as much relief as Celebrex without the complications.

Several months after the release of the above study results, the FDA issued an Alert in March 2005. The FDA Alert provided that “Based upon emerging information, including preliminary reports from one of several long term National Institutes of Health prevention studies, the risk of cardiovascular events [including myocardial infarction, cerebrovascular accident and death] may be increased in patients receiving Celebrex.” Following this March 2005 FDA Alert, in April 2005 the FDA officially requested that the package insert (i.e., labeling) for Celebrex be revised to include a “Black Box Warning,” a serious warning highlighting the potential increased risk of cardiovascular events, and additionally be revised to state that patients who have had heart surgery should not take Celebrex.

Celebrex remains on the market despite these serious safety concerns, albeit with more precise warnings concerning potential cardiovascular dangers. It is currently the only Cox-2 medication that has not been taken off the market. It is estimated that over 26 million people have taken Celebrex, and that Pfizer, Inc. has enjoyed sales exceeding $3 billion per year at the height of Celebrex’s popularity as a prescription pain medication.