Celebrex black box warning added

As reported earlier, at the direction of the FDA, Pfizer has agreed to add a black box warning to the label of Celebrex. Two other drugs in the Cox-2 category - Vioxx and Bextra - have since been banned worldwide.

According to the company, the final label contains a boxed warning of potential cardiovascular and gastrointestinal risks for Celebrex that will be consistent with warnings for other prescription pain relievers, including older, commonly used medicines like ibuprofen and naproxen. This addition follows a February 2005 meeting of an FDA advisory panel, which conducted a rigorous scientific review of selective and non-selective pain relievers. The panel recommended that stronger warnings be added to all selective COX-2 pain medicines as well as to the older, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. In addition, the panel recommended avoiding usage of all NSAIDs and Cox-2 selective medicines to treat the acute pain associated with heart by-pass surgery.

According to the broad guidelines provided by the FDA, Pfizer is saying that Celebrex (celecoxib) be prescribed at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The recommended dose for Celebrex is 200 mg daily for osteoarthritis and 200 mg to 400 mg daily for adult rheumatoid arthritis.

Sales of Celebrex have dropped rapidly after reports that Vioxx have killed tens of thousands of Americans and injured over 140,000 people. Both Merck and Pfizer are being targeted with thousands of lawsuits for hiding the risks of Cox-2 inhibitor drugs.

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