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
This is the fourth in a series of reports on the diet drug
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.
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.
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
But the problem is that serotonin doesn't just affect hunger.
It affects other functions, as well.
"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.
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
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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