March 3, 2006 at 11:03:02

Bextra - What Did Pfizer Know? - Everything

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By Evelyn Pringle (about the author) Page 4 of 4 page(s)

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Despite Pfizer's knowledge of the SJS problem, the company never placed a black-box warning on the label until the FDA ordered one in December 2004, critics say because it would have killed direct to consumer marketing which would have been required to show the warning.

In addition to strengthening the previous warning about SJS, the "boxed" warning ordered by the FDA in December 2004, warned consumers that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.

The FDA allowed Bextra to remain on the market until April 7, 2005.

When Pfizer suspended sales of the drug in April 2005, Health Canada, the equivalent of the FDA, issued a stop-sale order which ensured that Bextra would not return to the market in Canada without approval from the public health agency.

Health Canada has since studied all of the available evidence on COX-2 inhibitors in general and Bextra specifically, and decided that "the manufacturer will not be able to bring Bextra back onto the Canadian market under its present conditions of use."

The decision to stop the sale of Bextra," the agency said, "is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public."

In the US, on February 12, 2006, the Chicago Tribune reported that "advisers to the Food and Drug Administration said Bextra should stay off the market permanently."

However, the task remains for Pfizer, to explain why, in light of the evidence now known to the public, did it allow Bextra to remain on the market until April 7, 2005.

For more information for injured parties go to Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/bextra_knowledge.html

By Evelyn Pringle

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.

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