That's clearly criminal." In addition to the 2009 Bextra
scandal, Pfizer had been criticized earlier for unlawful actions involving other drugs.
, along with Vioxx (made by Merck & Co.), were types of anti-inflammatory drags often used for arthritis, called COX-2 inhibitors, and were pulled from the market by the FDA in 2005.
, an arthritis drug, was withdrawn from the market in 2005 over safety concerns.
But Pfizer marketed Bextra
for those unapproved uses anyway," he said.
"FDA Urges Limits on Celebrex, Bextra
." CNN.com Health News.
FDA action on two painkillers, Bextra
and Vioxx, shows the pharmaceutical companies' influence on the drug-approval process.
One need only consider the high profile recall of the arthritis drug Vioxx, which its manufacturer pulled from the market after it was shown to double the risk of heart attack and stroke, or the adverse effects warnings on prescription medications, including most recently Vioxx, Celebrex and Bextra
. This past February, sales of the multiple sclerosis drug Tysabri were suspended after it was suspected of triggering a rare brain disease in three patients, two of whom died.
Ever since reports of sudden heart attack and stroke prompted rofecoxib (Vioxx) and valdecoxib (Bextra
) to be taken off the market, other nonsteroidal anti-inflammatory drugs (NSAIDs) have been living under a shadow.
For instance, Pitruzzello pointed to the withdrawl of such cox-2-inhibiting nonsteroidal anti-inflammatory drugs as Vioxx and Bextra
. Ibuprofen has filled the void in these prescriptions, which, according to Pitruzzello, demonstrates how workers' compensation patients can now receive the care they need without new, expensive prescriptions.
And physicians are becoming more leery of thinking that every new drug represents a 'breakthrough' or improvement over existing therapies--something that resulted in part from the problems around Vioxx and Bextra
," she said.
In November 2001, the FDA granted approval to Pfizer for its COX-2 inhibitor valdecoxib (Bextra
) for three uses (menstrual pain, rheumatoid arthritis, and osteoarthritis), but rejected its application for acute pain.
suspension of sales of Bextra
and $2.19 billion associated with