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Too good to be true? Critics warn of Fen-Phen side effects

December 20, 1996
Web posted at: 9:15 a.m. EST

From Correspondent Elizabeth Cohen

drugs

This is the fourth in a series of reports on the diet drug Fen-Phen.

VENICE BEACH, California (CNN) -- Fen-Phen, the wonder-drug of the '90s, may make you skinnier, but it also may give you amnesia, depression, confusion or possibly even brain damage.

Phyllis Ojeda became depressed and forgetful after taking Fen-Phen for the first time.

"I was saying the alphabet to my grandson, and I couldn't remember what 'd' was. That scared me to death," she says.

Lynne Nieto, a nurse in California, says Ojeda's experience is not an isolated incident.

"One patient in Huntington Beach stated she suffered insomnia, she felt she was jumping out of her skin, irritability. She went to the emergency room, and she was referred to a psychiatrist," Nieto recalls.

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Another patient reported having a manic episode four days after going to a Fen-Phen clinic for the drug.

"Inevitably, nine out of 10 patients will have a (similar) story. It's terrifying," Nieto says.

Patients and doctors have contacted the Food and Drug Administration to report everything from manic-depressive reactions to anxiety to hallucinations while on Fen-Phen, but so far the regulatory agency has taken no action.

FDA officials say they're monitoring the situation but can't do much about it. "Our hands are tied because it is a combination medicine," said one official.

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That means the FDA approved Fenfluramine and Phentermine separately, but never approved doctors prescribing the two of them together in Fen-Phen.

Fenfluramine and Phentermine both work directly on the brain.

Fenfluramine tells your brain to make more serotonin, a naturally occurring chemical that makes you feel full. The more serotonin in your brain, the fuller you feel -- even if you haven't eaten very much. That's why people lose weight on Fen-Phen.

But the problem is that serotonin doesn't just affect hunger. It affects other functions, as well.

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"Serotonin is involved in mood regulation, in impulse control, in sleep, in appetite, aggressive tendency and a number of other behaviors," says Dr. George Ricaurte of John Hopkins Medical Institute.

Still, although Ricaurte's research shows Fenfluramine damages brain cells in baboons, he's not sure there are similar effects in humans.

"But there is every reason to be concerned that it may," he says. "Once you destroy them, (brain cells) don't have the potential to recover or regenerate. So these are not short- term effects that we're noticing one or two days after the drug treatment; these are long-lasting effects."

Meanwhile, drug companies are making millions off the combination. Wyaeth-Ayerst, the maker of Fenfluramine, has earned about $191 million so far this year.

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Wyaeth-Ayerst maintains there's no evidence of brain damage from Fenfluramine, but said it is monitoring side effects of a similar drug.

Until more research is completed, the full effects of Fenfluramine won't be known.

Nurse Nieto, for one, can't wait for the results.

"Here's this medication that's being massively prescribed -- or as one of my colleagues calls it, the 'pill mill,' --- massively prescribed to people without documentation," she says.

Meanwhile, clients continue to come to Nieto with problems related to Fen-Phen. Her response is to keep track of the side effects and help them find alternatives to diet pills.

 
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