Fen Phen Controversy


There has been evidence of the deadly effects Fen Phen can cause as far back as 1997, yet it is believed American Home Products, the manufacturer of Fen Phen had access to studies showing the heart problems their diet drug was causing far before that. Investigations performed by the FDA began in September 1997 and targets what AHP already knew about the drugs causing valvular heart disease. A report was written at the end of the inspection in November 1997 that cited several problems, including reporting, quality control, record keeping, and safety surveillance. The drug company never submitted any warnings on the conditions Fen Phen can cause, and they did not remove the product from the market until the FDA requested they do so in September 1997. The Fen Phen scare did not begin until the Mayo Clinic announced they had found a connection between Fen Phen and heart valve problems, which the FDA reacted to by immediately sending warning letters to thousands of doctors following the announcement.

The key reviewer of the FDA Dr. Leo Lutwak thinks his research was distorted by AHP to make it look like there was no way they could have predicted the serious heart valve problems that Fen Phen causes. An estimated eighteen million people were prescribed Fen Phen in 1996 prior to the withdrawal, and Lutwak believes that AHP was part of a cover up that would allow the drug company to continue to market and sell the diet drug. As early as October 1995, Lutwak had discouraged the use of Fen Phen and AHP company official were aware of this within 24-hours. Around 4,100 suits were pending at the time of the reported settlement. All federal diet drug cases were transferred to the U.S. District Court in December 1997.

The FDA did not want Lutwak to testify to show that AHP did have knowledge of the very damaging effects of Fen Phen, but Lutwak stated that “I followed the rules and regulations, I didn’t go public. I tried to work within the system, it didn’t work. People died as a result of a dangerous deadly drug being released,” (CBS News, 4/00). Heart valve defects are found to be 2-3 times greater among any Fen Phen users than among people who have never taken the drug. If you have experienced or have developed the serious health complications caused by Fen Phen, please contact us to learn your rights.

 

Fen Phen Frequently Asked Questions

What is Fen Phen?

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Fen Phen Websites

PPH Primary Pulmonary Hypertension - primary pulmonary hypertension or PPH lawyer specializing in fen phen lawsuit cases, including Redux and Pondimin lawsuits.

Fen Phen Lawyer Redux Settlement - Legal resource provides information on litigation relating to the Fen-Phen settlement.

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