Posted on 04/07/2005 11:49:37 AM PDT by neverdem
Edited on 04/07/2005 12:00:36 PM PDT by Admin Moderator. [history]
fizer Inc. agreed today to suspend sales of its painkiller Bextra at the request of the Food and Drug Administration, which also said it was instructing drug makers to better warn patients of the health risks of other widely used painkillers in the same class.
Bextra belongs to a class of drugs that has been linked to higher risk of cardiovascular disease, but the reason given by both the government and Pfizer for today's withdrawal of Bextra was an additional risk of a potentially serious skin reaction.
Pfizer said it disagreed with the government's position on the overall risks from Bextra, used to treat arthritis and similar ailments. But it said it would suspend marketing of Bextra pending discussions with the F.D.A. and added that patients should stop taking the drug.
The company also said it was temporarily withdrawing the drug from sale in Europe at the request of regulators there.
In a news release and public health advisory on its Web site, the F.D.A. announced new rules aimed at the marketing of not only cox-2 inhibitors like Bextra and Celebrex, another Pfizer drug, but also older over-the-counter pain relievers like ibuprofen and naproxen.
A boxed warning on a drug's label and an enclosed medication guide should highlight the potentially greater risk of "cardiovascular events," like heart attacks and strokes, and gastrointestinal bleeding associated with taking the drug.
A list of such medications, known as non-steroidal anti-inflammatory drugs, is available on the F.D.A.'s Web site at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.
The F.D.A. said the actions "are based on the available scientific data, including data accumulated since the drugs were approved."
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," Dr. Steven K. Galson, acting director of the F.D.A.'s Center for Drug Evaluation and Research, said in a statement.
The agency's re-examination of the health risks of such drugs began after Merck voluntarily withdrew Vioxx worldwide in September 2004. Since then, the popular cox-2 drugs, which have treated millions of people with arthritis and other chronic ailments, have been in danger of removal from the market, calling into question the financial health of their makers and the rigor of the F.D.A.
The F.D.A. said today that it "will carefully review any proposal from Merck for resumption of marketing of Vioxx."
In explaining its decision on Bextra, the F.D.A. said, "the overall risk versus benefit profile for the drug is unfavorable."
"Pfizer respectfully disagrees with F.D.A.'s position regarding the overall risk/benefit profile of Bextra," Pfizer said in a statement. "However, in deference to the agency's views, the company has agreed to suspend sales of the medicine pending further discussions with the F.D.A." It also said that it would suspend sales of Bextra in the European Union as requested today by regulators there. The European Medicines Agency described the suspension as an "interim measure" awaiting the completion of a review of cox-2 inhibitors, which it began after Merck's withdrawal of Vioxx. It said it will release an update of its plans after an April 18-21 meeting of the agency's Committee for Medicinal Products for Human Use..
For Pfizer, the world's largest drug maker, complying with the F.D.A.'s request may compromise the profit growth that the company forecast only on Tuesday in a meeting with Wall Street analysts. Though it said that 2005 would be a "transition year" of cost cutting and research spending, it had predicted double-digit earnings growth starting in 2006.
Moreover, an advisory panel of doctors convened by the F.D.A. earlier this year narrowly voted to keep Bextra on the market.
"It's a setback; we had been assuming that Bextra would probably be staying on the market," said Carl Seiden, an equity analyst at UBS who still rates the stock a buy. "We're going to assume that Bextra revenues are simply lost and not made up by Celebrex." That would mean a $560 million loss in worldwide revenues, or about 2 1/2 percent of the company's projected earnings, according to Mr. Seiden's calculations.
Still, he said, "relative to the strategic direction they set a couple of days ago," including a restructuring that would cut costs by $4 billion a year, "this doesn't meaningfully change the company's trajectory."Shares of Pfizer on the New York Stock Exchange were down 36 cents to $26.50 a share at midafternoon.In response to the F.D.A.'s new labeling rules, which affect Celebrex, the company said: "Pfizer and the F.D.A. plan further discussions regarding the precise content of the Celebrex label." It defended Celebrex's safety, citing clinical data spanning 10 years and involving more than 40,000 patients.
Sales for Celebrex last year totaled $3.3 billion, and those for Bextra totaled $1.3 billion. Sales of both drugs are now about half what they were last fall.
Once hailed as super-painkillers, cox-2 inhibitors like Celebrex, Vioxx and Bextra were seen as better treatments for persistent pain because they were less likely to cause stomach bleeding than common drugs like naproxen and ibuprofen.
Doctors may now advise their patients to return to those longstanding medications.
"The old-line drugs first, and then Celebrex," said Antonio Gotto, a cardiologist and dean of Weill Medical College at Cornell University.
"Where you have a patient that is known to have cardiovascular disease, or be at high risk of cardiovascular disease, I would not be inclined to treat him with Celebrex."
Pfizer said it was not told of the F.D.A.'s decision to ask for Bextra's withdrawal from the market until Wednesday, a day after its meeting with analysts.
The stock is barely down...
Stick with 2 ibuprofin and 2 extra strength acetominiphin,taken together,for pain.Every 4 hours.
Recommended by my MD for an ear infection and I even used it after coming home from surgery instead of a prescribed pain killer.
p.s.---Check your doctor first,of course.
They had no choice. Once the government recommended it, they had to or risk even more lawsuits than I am sure they will be getting already.
Great. Both my wife and my mother are on Bextra, it is the only drug strong enough short of narcotics to relieve their arthritis pain. Their doctors have both said that nothing else will work for them without causing greater peripheral damage to their bodies.
Now what?
Oh hell!
VIOXX was a wonder drug for me and when it was pulled, I had a tough time finding any relief. Celebrex does nothing for me and my doctor finally gave me some Bextra samples 2 weeks ago and it has worked well.
I guess I'll eventually have to go to the projects and get some smack.
A boxed warning on a drug's label and an enclosed medication guide should highlight the potentially greater risk of "cardiovascular events," like heart attacks and strokes, and gastrointestinal bleeding associated with taking the drug.
These control freaks are not going to be happy until they make all pain killers are made illegal to use, have or sell; and that this nation's population (barring themselves) are in constant pain.
These control freaks are sadists, it's the only logical explaination for their on going war against america's pain chonic pain suffers.
Medical marijuana.
or
try Vancouver, B.C.
http://www.freerepublic.com/focus/f-news/1360508/posts
Ditto. Dr.'s are getting too scared to aggressively treat chronic pain for fear of some snotty bureaucrat reading a spreadsheet somewhere with penis envy, calling in the jackbooted thugs because he violated a prime directive and dragged off to Federal jail.
acetominiphin is not your friend. be careful.
FReepmail me if you want on or off my health and science ping list.
I rarely take pain medication-----once or twice a year---if that.
I'm a very lucky person.
Or younger than 50.
A company as big as Pfizer will not market Rx drugs that bring in less than 300 million/year. Marketing/sales too expensive.
Waaaaay over 50. LOL
OK....lucky.
No! If you must, at least alternate - one type now, the other in 4 hours. But, don't do this more than you absolutely have to, because you are "hitting" your kidneys and liver from 2 sides.
I don't know what I'm going to do - Bextra is all that works for me. No to little risk of heart disease in my family - before 80, anyway.
Besides, what *do* you want to die of? Starvation?
You want to join in my law suit? I've been threatening to sue, 'cause Bextra's the only thing that works.
I've only done it twice---the ear infection and after the surgery.
High blood preassure makes me avoid most of that stuff and,as I posted before,I've been very lucky.
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