Doctors and pharmacists in the tri-county area expect a wave of anxiety to crash over their patients once they learn Pfizer Inc. pulled its popular arthritis painkiller Bextra off the market Thursday. A Montgomery lawyer said his lawsuit caseload against the drug manufacturer will grow larger.
The U.S. Food and Drug Administration recommended the action. The agency also ordered Pfizer to put a strong warning label on Celebrex and other prescription medications used to treat arthritic patients.
"I've got dozens, hundreds of patients on them," said Dr. Tucker Mattox, an orthopedic surgeon with Southern Orthopedic Surgeons in Montgomery. Millions of patients nationwide have been prescribed the painkiller for arthritis and menstrual discomfort. Mattox said his patients were asking him all day if the risk of taking the medication is real and what their options are.
"I've got a lot of patients who have problems enough to come see the doctor" for the prescriptions because of limited mobility brought on by arthritis pain and swelling, Mattox said. "If that is taken away from us, there's going to be a lot of patients who suffer."
Mattox said doctors will need to determine whether over-the-counter medications should be used to replace the prescription medications, or whether to use older generation arthritis drugs-assuming they are still in production since falling out of favor for the newer wonder drugs.
Montgomery attorney Jere Beasley, who has filed product liability lawsuits against Pfizer, applauded the FDA ruling.
"The FDA should have done that a long time ago. Why they waited so long I don't know," said Beasley.
"We have filed some Bextra cases already all over the country. Right now we're looking at probably over 1,000" cases, Beasley said. "We'll probably file, out of that, 250 or 300" lawsuits.
A phone call to Pfizer seeking comment was not returned.
In a release announcing the action against Bextra, the FDA said the agency concluded "the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market."
The request was based on "the lack of adequate data on the cardiovascular safety of long-term use of Bextra," as well as "reports of serious and potentially life-threatening skin reactions, including deaths," the FDA release stated.
Pfizer's suspension of Bextra sales was accompanied by an FDA order for so-called "black-box warnings"-the strongest cautions issued by the agency-about the increased risk of heart attacks and strokes to be placed on packages of Celebrex and similar medications.
Bextra and Celebrex are in a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The FDA asked manufacturers of over-the-counter painkillers in that class of medications, such as Ibuprofen and Aleve, to relabel their packages to warn of the risks of heart attack, strokes, gastrointestinal bleeding and serious skin reactions.
Kim McHugh, pharmacy manager at the Prattville Walgreen's store on Main Street, said no customers complained Thursday about the Bextra ban. But if past is prologue, that will change swiftly as users hear the news.
"They flipped out over Vioxx," she said. Vioxx was a competitor of Bextra. It was pulled off the shelves voluntarily by its maker, Merck Pharmaceuticals, last summer after tests indicated some risks associated with it.
McHugh expects similar reactions from Bextra users, many of whom switched to that painkiller after Vioxx sales were suspended.
Thursday's action left her pharmacy with about 600 unsold pills, but McHugh could not tally up the cost because the corporate office already had removed the Bextra information from the computer system. Fortunately, she said, a shipment of the pills that was to arrive Thursday was canceled.
The makers of Vioxx issued credit for unused tablets being held by patients and pharmacies, McHugh said. She has received no word whether Pfizer will do likewise with leftover Bextra pills.
"I would be extremely concerned at how ineffective the FDA has been" in its approval process for new drugs, Beasley said.