The U.S. National Institutes of Health said Monday that it stopped giving Celebrex and Aleve after patients who received the latter drug were shown to have a higher risk of heart attacks or strokes.
”In the light of what we know about Vioxx in particular, we have to ask that question: Is this a class phenomenon to all the nonsteroidal anti-inflammatory drugs?” said Sandra Kweder, with the Food and Drug Administration.
The NIH study was seeking a treatment to prevent Alzheimer’s disease. Patients who were taking naproxen, sold over the counter as Aleve, were shown to have an increase in heart attacks or strokes versus the placebo group.
Those on Celebrex did not, the Bethesda, Md.-based agency said in a conference call with reporters. About 2,400 patients participated in the study.
Pfizer on Dec. 17 released a separate study that found higher doses of Celebrex more than doubled the risk of heart attack in patients at risk for precancerous colon growths.
Pfizer, the world’s largest drugmaker, agreed to stop promoting Celebrex to consumers while U.S. regulators evaluate the new data, the company said Sunday. Acting Food and Drug Administration Commissioner Lester Crawford, who hasn’t ruled out a recall of the drug, urged doctors Friday to consider alternatives to Celebrex or prescribe it only in low doses.
Today, doctors at Brigham and Women’s Hospital and Massachusetts General Hospital in Boston, will make recommendations about Celebrex, in light of the Pfizer study.
The Alzheimer’s research is being sponsored by the National Institute on Aging, the NIH said in an e-mailed statement.
NIH made the announcement after U.S. markets closed. Shares of Pfizer dropped $1.46, or 5.7 percent, to $24.29 in New York Stock Exchange composite trading. Pfizer’s market value has plunged by $35 billion in the past two trading days.
Patients taking naproxen shouldn’t exceed the recommended dose and shouldn’t take the medicine for more than 10 days, said Steve Galson, with the U.S. Food and Drug Administration.
”Although we have not had the opportunity to see the actual data, we are concerned that this side effect occurred at a dose of Celebrex that is taken by many patients with arthritis,” according to the website of New York’s Hospital for Special Surgery, the oldest orthopedic hospital in the country. “Until the data can be fully reviewed, we are recommending that patients who absolutely need this drug for control of arthritis contact their physicians.”
Pfizer Chief Executive Hank McKinnell said in an interview Monday with financial news network CNBC that Celebrex should remain on the market. The company’s own studies have failed to turn up a heart risk, McKinnell said in the interview.
The company is planning studies next year that may show that Celebrex actually cut heart risk, McKinnell told CNBC. An FDA committee will review the drug in February, McKinnell said.
”I would hope we are not rushed to judgment before we are able to look at all the evidence,” McKinnell told CNBC.
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