| Bextra Pulled Off Market; FDA Cites Patient Health Risks
By Barbara Morse Silva
April 7, 2005
The Federal Drug Administration is concerned about the side effects of Bextra.
Millions of people use Bextra to beat the pain.
But Bextra is the latest prescription painkiller to come off the market after the FDA concluded it comes with unique risks to patient health -- and no special benefit. It has the additional elevated risk of adverse skin reactions.
In a sweeping move, the FDA has heightened its label requirements for drugs such as Bextra, that's most prescription and over the counter painkillers, to include warnings of increased risk of heart problems.
The blockbuster painkiller, Celebrex, also made by Pfizer will now come with a black box warning that forces Pfizer to temper its advertising of the drug.
Over the counter painkillers, including Ibuprofen sold in products like Motrin and Naprosyn sold as Aleve, will now come with stronger warnings about possible stomach bleeding and possible increased risk of heart attacks.
Painkillers not affected by the new FDA warnings include Aspirin, which the agency said has unique benefits, as well as Tylenol and prescription narcotics.
As for the over the counter pain relievers, the FDA said when taken as advised, they should be safe. But experts inside and outside the government added that all drugs have risks, which are only lessened when taken short term at a less dose.
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