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CELEBREX : Celebrex News Log Home : 2004-12-21 : Article

Lawmaker calls for FDA review amid drug safety troubles

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Pfizer: Celebrex

"It seems the time has come for a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs," said Senator Chuck Grassley, chair of the Senate finance committee, which oversees the FDA.

"Today, Pfizer released information about an increased risk of heart attack for its drug Celebrex, and Eli Lilly issued a new warning about liver problems with the drug Strattera. The last year revealed serious problems involving children and anti-depressants, painkillers like Vioxx, Bextra and Celebrex, the flu vaccine, and the AIDS (news - web sites) drug nevirapine," Grassley said Friday. "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us."

Pfizer's chairman Hank McKinnell said the drug would not be withdrawn. "Any decision to withdraw a drug has to be made in the context of all of the information," McKinnell told CNBC television. "Until the study results became known to us late last night we saw a very acceptable safety profile for Celebrex. I don't think this one study, even though it is a large, well-controlled study, characterizes the drug in any significant way," McKinnell said.

McKinnell said: "These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study.... Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC


 


 

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