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Diet drug company unaware of FBI investigation

 

WASHINGTON (Reuters) -- American Home Products (AHP) Corporation said on Thursday that it was not aware of any Federal Bureau of Investigation (FBI) probe of how it won approval for two diet pills that were linked to heart problems and pulled from the market.

The Wall Street Journal reported on Thursday that the FBI was trying to find out whether AHP told the Food and Drug Administration (FDA) everything it knew about adverse reactions to the diet pills, fenfluramine (Redux) and phentermine (Pondimin), which are known as the "fen-phen" diet drug combination.

 

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AHP's General Counsel, Louis Hoynes, said in a statement, "American Home Products is absolutely unaware of any investigation by the US Department of Justice or the Federal Bureau of Investigation relating to diet drugs."

Hoynes said, "We know of no basis for such an investigation, and we are confident that American Home Products' actions with respect to Pondimin and Redux were at all times lawful and appropriate."

An FBI spokesman said that he could not confirm or deny whether agents were investigating the matter. "It's long-standing FBI policy that we cannot confirm or deny the existence of an FBI investigation," said spokesman Gregg Horner, a spokesman for the FBI's Washington office.

However, a federal law enforcement official who requested anonymity said that such an FBI probe is underway.

An FDA spokesman said that the agency would have no comment on the matter.

Redux was approved in 1996, but AHP withdrew the drug and Pondimin in 1997 after both were linked to heart valve damage. Redux was also sold by Interneuron Pharmaceuticals through a marketing arrangement with AHP.

AHP is facing more than 4,000 lawsuits from patients who allege that they were harmed by the adverse effects of Pondimin and Redux. A Texas jury awarded one women who took fen-phen $23.3 million in damages.

At the end of August, a federal judge ruled that the fen-phen cases against AHP could be consolidated in a class-action suit, except in six states where courts have already granted "medical monitoring" class-action status.

News of the FBI investigation is the latest in a series of bad news for AHP. In addition to the ongoing legal problems related to fen-phen, the company also has settled suits with more than 36,000 women who used its Norplant contraceptive device. The company also had to recall its Duract painkiller due to liver problems among long-term users.

Last month, AHP suspended shipments of its rotavirus vaccine after it was linked to bowel obstructions in 32 infants. The company also recalled certain lots of its epinephrine-based allergy kits last week due to lack of potency.

On Wednesday evening, a New York City law firm announced that it had launched a $500 million lawsuit against AHP related to its diphtheria, tetanus, and pertussis (DTP) children's vaccine for allegedly causing brain damage to the plaintiff.

In early afternoon trading on Thursday, shares in American Home Products dropped 3-7/16 to 38-7/8.

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