Also, patients are to receive a special pamphlet with every NSAID prescription filled that spells out the warnings in consumer-friendly language. The FDA cautioned that those claims were never proven. It should be prescribed only for patients not taking other painkillers, or who are at particularly high risk for stomach problems, said Vanderbilt University pharmacologist Dr. Alastair Wood, who advises the FDA on drug safety. For chronic pain, such as arthritis, Wood recommends starting patients on the NSAID naproxen, along with a stomach-protecting drug if necessary.
Give directly to The Spokesman-Review's Northwest Passages community forums series -- which helps to offset the costs of several reporter and editor positions at the newspaper -- by using the easy options below. Arthritis drug Bextra withdrawn from market in Canada, U. CBC News Loaded. Science Arthritis drug Bextra withdrawn from market in Canada, U. Pfizer agrees to pull its COX-2 inhibitor Bextra from pharmacy shelves. Social Sharing.
In calling for a stronger warning on Celebrex labels, the FDA cited increased risk of cardiovascular "events" and gastrointestinal bleeding and said all similar drugs should have label warnings.
The New York-based drugmaker said in a statement that it planned further discussions with the agency over the content of the Celebrex label and would explore options to making Bextra available in the future. To read Pfizer's statement, click here. The FDA said patients taking Bextra should contact their physicians to consider alternative treatments. An FDA spokesman was not immediately available for further comment.
To read the FDA's statement, click here. Pfizer and the FDA said Celebrex is one of the options for arthritis pain at the "lowest effective dose for appropriate patients. Drug industry analyst C. Sylvester at Banc of America said the Bextra withdrawal took him by surprise, noting it came just two days after Pfizer executives said sales of the arthritis drugs would be reinvigorated in coming months.
Barbara Ryan, analyst for Deutsche Bank North America, said Pfizer's withdrawal of Bextra will have a limited impact on the company's revenue because the drug was already experiencing reduced sales this year. In an interview with CNN, Lehman Brothers analyst Anthony Butler said that Pfizer's large revenue base gives it the flexibility to ride out a loss in product sales.
0コメント