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The FDA approved Celebrex, currently the only COX-2 inhibitor prescribed in the U.S., in 1998 for treating rheumatoid arthritis and osteoarthritis and in 1999 for reducing intestinal polyps in patients with familial adenomatous polyposis.

Just three years later, however, elevated heart attack and stroke risks began to surface, and the FDA followed with a warning to manufacturers Pfizers and Pharmacia Corp. about dishonest promotional practices. Over the past 13 years, plaintiffs have filed lawsuits alleging understated side effects and concealed results, illegal marketing, and false research concerning Celebrex and generic equivalent Celecoxib.

Studies and Warnings

By September 2011, the American Heart Association, National Stroke Association, and Arthritis Foundation requested Pharmacia test Celebrex for heart attack and stroke risks. Studies later revealed that the drug doubled patients’ risk for these and other life-threatening cardiovascular conditions.

One published in the Archives of Internal Medicine showed that 63 percent of all prescribed patients had a low but elevated risk for life-threatening cardiovascular conditions, while Celebrex, contrary to marketing claims, was no more safer or more effective than other NSAIDs.

Another from the University of Pennsylvania found that the drug directly creates an imbalance in a patient’s cardiovascular system. Then, a Danish study presented by the AHA in 2005 found that Celebrex elevated death risks for patients who already experienced at least one heart attack. Specifically, 200mg once per day made a four-fold increase.

All contradict Pharmacia’s and Pfizer’s initial reporting, which claimed Celebrex is easier on the stomach than other NSAIDs. It was later found that the manufacturers only released six months of data from a year-long study.

If you can recall, Celebrex commercials claimed the medication improves patients’ overall quality of life, but by 2001, the FDA sent Pfizer a warning about its advertising practices, requiring the company to cease all activities.

As well, the FDA followed this first warning five years later, requiring Pfizer and Pharmacia to add labels claiming increased cardiovascular risks and gastrointestinal bleeding.

Along with these claims, a 2006 Canadian study published in Med Page Today revealed that pregnant women taking Celebrex during the first trimester were at an 8.8-percent greater risk of having children with birth defects.

Lawsuits

Plaintiffs began filing lawsuits against Pfizer and Pharmacia in 2006, alleging the manufacturers aggressively marketed Celebrex with misleading claims, which led to over-prescription.

By 2012, Pfizer settled a class action lawsuit from its shareholders for $164 million. The plaintiffs claimed Pfizer misrepresented data from its clinical trials to make Celebrex appear better to similar NSAIDs.

As well, a 2010 investigation and lawsuit found a Bay State Hospital doctor involved in studies for Celebrex, Bextra, Vioxx, Effexor, and Lyrica from 1996 to 2008 had fabricated data about post-surgical benefits. Dr. Scott S. Reuben’s forged results further influenced the FDA to put these drugs on the market and to lessen restrictions on painkillers. While Dr. Reuben has since been barred from practicing medicine, his falsified claims put millions of patients at risk over the years.

As a class, COX-2 inhibitors have been associated with blood clots, heart attacks, and strokes, and Celebrex remains the only such drug still prescribed in the U.S., with 2.4 million Americans taking it at some point.

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