Critics say millions of people were needlessly exposed to the risks of Bextra due to intense off-label promotion and advertising that boosted the painkiller to a position near the top of the list of the most widely prescribed drugs in US history.
Although a drug can only be marketed for specific indications approved by the FDA, doctors are allowed to prescribe a drug for any use regardless of whether its approved for a diagnosis and Pfizer spent a fortune on convincing physicians to prescribe Bextra for unapproved uses.
In 2003, the number of prescriptions written for Bextra totaled 10.4 million. In the same year, the cost of promotions aimed at prescribing doctors reached $395.6 million, according to IMS Health, a pharmaceutical information and consulting company.
And the money doled out to influence doctors paid off. In 2003, IMS reported sales of Bextra totaled $935 million and in 2004, CNN Money Line said Bextra had sales of $1.3 billion. In 2004, 12.9 million prescriptions were filled in the US for Bextra.
According to the FDA, Bextra was approved for the treatment of pain associated with osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain).
Yet two Pfizer sales representatives recently told ABC News channel 7, Reporter Andrea McCarren in a TV interview, that they were told to promote Bextra for: "Heel pain, back pain, pain from orthopedic surgeries, any kind of pain."
"Going into hospitals getting in on pain protocols and that's completely illegal," the first sales rep said.
Another rep told Ms McCarren: "We were expected to sell it for pre-operative pain and post-operative pain, which is totally out of indication."
"And there is a huge amount of money that can be made for a drug that gets sold for that," the second rep said in the interview.
According to a May 2004 analysis conducted by Knight Ridder, half of all Bextra sold was prescribed for off-label uses.
In a March 2004 regulatory filing, Pfizer disclosed the company was under scrutiny by the US Justice Department over its off-label marketing of the drug for unapproved uses.
The worst part about the off-label marketing of Bextra, is that studies revealed over the past several years show the drug to be no better than other pain medications, as dangerous or more dangerous than other pain relievers, and the drug should never have been prescribed for any use. And worst of all, Pfizer knew it.
A report published in the December 3, 2005 British Medical Journal claims drugs like Bextra are just as harmful to the stomach as conventional anti-inflammatory drugs like aspirin, which debunks the main reason that drugs in this class were approved and over-prescribed to begin with.
According to the FDA web site accessed on January 24, 2006, under Special Warnings: "Bextra and all NSAID medications can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Bextra, but it can also happen suddenly."
The FDA told consumers to call a doctor right away if you get:
a burning stomach pain black bowel movements that look like tar vomit that looks like blood or coffee grounds
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