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In August 2005, the FDA announced the order of a major Celebrex label change to reflect recent findings about the drug’s risks and benefits. News of the Celebrex label change is mixed- the FDA ordered a black box warning regarding the serious life threatening risks associated with Celebrex. They also approved the drug for the treatment of a condition not previously approved. This Celebrex label change has many consumers wondering whether Celebrex is or is not safe for use.

The FDA organized an advisory panel to investigate serious cardiovascular and gastrointestinal risks associated with Celebrex and all selective and non-selective non steroidal anti-inflammatory drugs (NSAIDs). This panel was convened in early 2005 after Vioxx and Bextra COX-2 NSAIDs had been pulled off the market for unacceptable risks and studies indicated similar risks for Celebrex and other NSAIDs.

Based on their investigation, the FDA opted not order a Celebrex recall, but instead a Celebrex label change that would inform patients about serious potential risks. The FDA ordered a black box warning to be included in the Celebrex label change. A black box is the strongest warning the FDA can order short of a recall. This black box Celebrex label change informs consumers about cardiovascular and gastrointestinal risks.

The Celebrex label now states that this drug increases a patient’s risk of developing serious cardiovascular risks including: cardiovascular thrombotic events (blood clots), myocardial infarction (heart attack), and stroke. According to clinical trial results, a patient taking Celebrex may double or triple their risk of developing one of these life threatening side effects. The Celebrex label change states that Celebrex should not be used to treat pain associated with heart by-pass surgery.

The Celebrex label change also indicates that patients may be at an increased risk of suffering gastrointestinal side effects. Celebrex use can increase a patient’s risk of developing potentially fatal complications including gastrointestinal bleeding, ulceration, and perforation or tearing of the stomach or intestinal lining.

In light of these serious life threatening risks, the Celebrex label change recommends that patients be prescribed the lowest dose of Celebrex possible for the shortest duration required to achieve the desired treatment. The recommended doses for osteoarthritis and rheumatoid arthritis are 200mg and 400mg, respectively. Patients taking Celebrex for Familial Adenomatous Polyposis (FAP) are to take no more than 800mg daily.

The Celebrex label change also indicates a new use of this painkiller. Celebrex is now approved to treat ankylosing spondylitis at a recommended dose of 200mg a day. Ankylosing spondylitis is a form of arthritis in the spine that commonly affects people aged 18-35. This condition affects up to 40,000 Americans each year and can cause serious inflammation, pain, and stiffness in several areas of the body.

If you would like to learn more about the recent Celebrex label change or if you have been injured by this medication, please contact us to speak with a qualified and experienced attorney in your area.

"Celebrex safety concerns reaps benefits for alternative painkillers"

After COX-2 painkillers – Vioxx, Celebrex and Bextra- came under scrutiny when cardiovascular risks were associated to the drugs some drugmakers saw this as an opportunity to try to capitalize on the events.

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Merck & Co. and Pfizer Inc. have been criticized for their aggressive marketing campaigns for its COX-2 drugs, putting scrutiny on pharmaceutical advertising as a whole. Between December 2003 and November 2004, pharmaceutical ad spending increased 30...

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"COX-2 safety questions far from answered"

A three-day FDA Advisory Committee meeting has wrapped, but the COX-2 drugs controversy is still not resolved. Although the panel of government medical experts advised keeping the drugs, including Pfizer Inc.’s Celebrex and Bextra, on the market, new...

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