Celebrex Recall Risk

Celebrex, one of the arthritis pain relieving drugs manufactured by Pfizer, entered the US Market in 1999. It was very popular, but just 3 months after the introduction into the market, people began to question the drug after reports linked to death and serious side effects in patients taking the drug.

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Individuals who were taking the drug to relieve the pain of arthritis were experiencing:

• gastrointestinal hemorrhages
• cardiovascular problems
• kidney and liver damages
• ulcers
• death

The FDA warned Pfizer to start changing their promotional advertisements because they were misrepresenting the safety of its use. No changes were implemented, so on April 6, 2000 the FDA sent a letter to Pfizer saying that they were not satisfied with the company's representation of the safety information, the unsubstantiated comparative claims, the lack of fair balance, and the misrepresentation of efficacy information.

The advertisements in question claimed that this medication was safer and gentler on the stomach compared to older NSAIDs. A study performed, called the CLASS study, proved this statement to be false. It concluded that the "clinically meaningful" safety advantage to taking it over its competitors had not been established. It also failed to prove that it worked any more safely than other NSAIDs regarding ulcer complications.

The manufacturer was more concerned with selling their product and making money than protecting the consumers who were taking the medication. They began to make television ads without directly naming Celebrex. This enabled them to avoid Federal laws requiring side effects to be stated on the advertisements.

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A study confirmed that participants who were taking 400-800 milligrams were 2.5 times more likely to suffer an adverse cardiovascular event than participants in the placebo group. The results of this study were publicly announced on December 17, 2004, and Pfizer claimed that they were taking immediate steps to investigate these findings and promised to inform everyone about the dangers. They also announced that there was no intention to recall the drug from the market.

Recent evidence has shown that there are additional adverse side effects related to the drug, aside from potential cardiovascular problems. People taking the drug are at an increased risk of developing potentially fatal gastrointestinal bleeding (ulcers). Increased danger is also possible in patients who have a history of allergic reaction to aspirin, other arthritis medications, or certain sulfa drugs (sulfonamides). Last, but not least, patients who suffer from high blood pressure, fluid retention, or heart problems may also be at an increased danger for serious health complications.

While Celebrex still remains on the market, sales of the drug have been cut in half from $3.3 billion in 2004 to $1.7 billion in 2005. Additionally, the FDA issued a "black box," the most serious health warning, short of a recall, to the label letting millions of consumers know of the risks associated with the drug including heart attacks, strokes, and gastrointestinal bleeding.

The first Celebrex lawsuit in the United States, which was filed in 2005 against Pfizer, began June 2006 in Alabama. The 53 year old Alabama resident was prescribed the arthritis medication and suffered a stroke in February 2005. She sued Pfizer, the manufacturer of the drug.

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