In 2005, following the Food and Drug Administration (FDA)'s decision to requrie "black box warnings" regarding the potential cardiovascular and other side effects of COX-II pain relievers and non-steroidal anti-inflammatory drugs (NSAIDs), Pfizer, Inc. began working with the FDA to add expanded risk information for Celebrex. Celebrex is the only COX-II inhibitor still available on the market. The boxed warnings now contain information regarding many cardiovascular and gastrointestinal side effecs and potential serious skin reactions, including Stevens-Johnson Syndrome, that can cause injury and even death.

The new warnings include information on:

• Stomach ulcers that bleed and can cause other health risks. The chance of developing these side effects, which can occur suddenly, increases the longer a patient takes Celebrex.
• A variety of different types of liver damage. Some of the warning signs of liver damage include nausea, vomiting, extreme tiredness, a loss of appetite, itching and swelling, a “yellowing” of the skin or eyes, “flu-like” symptoms, and dark urine.
• Kidney problems, including sudden kidney failure or the worsening of pre-existing kidney problems.
• Fluid retention and swelling, which can be a serious problem for people who have high blood pressure or have experienced heart problems in the past.

The first Celebrex lawsuit, a class action comprising of over 150 individuals, was filed against Pfizer, Inc. in April 2006. It has been surmised that a number of studies indicating the serious side effects associated with the use of Celebrex and other COX-II inhibitors will be introduced in this litigation. One key source of possible evidence is a study conducted by a private health insurance group that confirms fears that COX-II inhibitors cause serious cardiovascular events. In addition, in February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx all increase the risks of a heart attack or a stroke in patients. The study and research indicates that the risk of having a heart attack was over 50 percent higher than normal for patients who took Bextra and almost 20 percent higher for those who took Celebrex. The other drug, Vioxx, showed a 23 percent increase in serious heart incidents. The study did not find increases in cardiovascular events in patients who took traditional anti-inflammatory medications.

The New Zealand Medical Research Institute produced a study that claimed people who took Celebrex were almost twice as likely to suffer a heart attack as people using other treatments to relieve arthritis pain. The report reviewed six studies involving almost 13,000 patients and found that those who took Celebrex had an almost doubled risk of heart attack compared to patients who took other drugs.

In 2005, an FDA panel said that COX-II drugs should stay on the market because the drugs' benefits outweighed their potential dangerous side effects. The advisory panel voted 31-1 to keep Celebrex on the market. It also voted 17-13 to keep Bextra available to patients and favored Vioxx by a vote of 17-16. Although the FDA does not always have to follow the panel's recommendations, the agency generally does. Both Bextra and Vioxx have been recalled since the panel’s recommendations and remain off the market.

The sales of Celebrex were reduced by almost 50 percent, to $1.7 billion in 2005 from $3.3 billion in 2004. A number of consumer groups have stated that although the public should be aware of the dangers of Celebrex given all the negative press reports, and that the reduction in sales is an indicator of the dangers, they believe all COX-II inhibitors should be removed from the market. These groups continue to monitor new research studies and to petition the FDA to have Celebrex included in the recall and removed from the market.

Any individual or family member who believes they or another individual has been harmed or suffered adverse health effects from the usage of Celebrex should seek the advice of an attorney who specializes in pharmaceutical litigation.