Pfizer Pulls Bextra. Pfizer has decided to also follow the US Food and Drug Administration ruling in the United Arab Emirates and withdraw its painkiller Bextra.
Risks To The Heart And Stomach
The company still hopes that the drug may be re-introduced but the FDA said its risks to the heart and stomach outweighed potential benefits. Pfizer Inc. and its subsidiary, Pharmacia & Upjohn Company Inc., have agreed to pay a record-setting $2.3 billion to settle claims arising from the illegal marketing of some drugs. According to a U.S. Department of Justice press release, Pharmacia & Upjohn Company has also agreed to plead guilty to a felony violation regarding off-label promotions of the painkiller Bextra.
As we’ve reported previously, doctors may prescribe Food & Drug Administration-approved medicines any way they see fit. But companies are legally barred from promoting unapproved, or so-called off-label, uses. According to the Justice Department press release, Pharmacia & Upjohn Company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter, for the Bextra promotions.
Need Legal Help Regarding Bextra?
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