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Slippery Slope: Fen-Phen Users Recall a 'Miracle' Turned Nightmare

— Fen-phen use was linked to heart valve damage, as these two cases illustrate.

MedpageToday
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Phyllis Hardy sits on her living room couch with some of her paperwork involved in her legal case against a drug company regarding heart valve damage she suffered after using a diet pill. Photo from Milwaukee Journal-Sentinel by Mike De Sisti

In the mid 1990s, Phyllis Hardy was eager to try the new "miracle medicine" that co-workers at her hospital in Milwaukee were using to effortlessly shed pounds.

At the time, she was in her late 30s and weighed more than 300 pounds. Her doctor prescribed the combination drug fenfluramine and phentermine -- known as "fen-phen" -- and within a few months she had lost more than 25 pounds.

"When you are fat, you just want to lose weight," Hardy said, then added. "I haven't been right since."

In 1997, the FDA ordered Wyeth to remove fenfluramine (Pondimin) and a related drug, dexfenfluramine (Redux) from the market, after a study showed they caused damage to heart valves. That effectively put an end to the fen-phen craze.

Hardy, now 57, believes fen-phen -- which she took for several months -- caused her to develop a leaky heart valve.

She takes heart medications that address her symptoms, including drugs that slow her heart rate and lower her blood pressure. She gets winded at times and said she has had a burning sensation in the throat ever since using the drugs.

Fen-phen is one of many weight-loss treatments that gained rapid popularity, only to be pulled from pharmacy shelves when problems were revealed.

"It's a cycle perpetuated by the FDA," said , an assistant professor of medicine at Harvard Medical School. "It's been going on since the amphetamines came out in the 1920s and '30s."

Cohen said the problem is the FDA typically approves the drugs after they show modest, short-term weight loss -- but without proof of a long-term benefit, such as a reduction in heart attacks, strokes, or cardiovascular deaths.

Only when problems arise does the FDA take action, said Cohen, who wrote a -- a diet treatment popular in the 1950s and '60s.

Beginning in 1997, fen-phen unraveled as the biggest weight-loss drug debacle ever.

Ultimately, 175,000 claims were filed against Wyeth, which set aside $21 billion to settle the lawsuits, according to a

Julie Flessas, a critical care nurse-turned-attorney, was a key player in those lawsuits.

In 2002, her Mequon law firm hired a group of cardiologists in Kansas City to send echocardiogram technicians to Milwaukee to perform ultrasound scans on fen-phen users.

They set up testing sites at area hotels -- complete with hospital beds and state-of-the-art equipment -- in an effort to replicate what would happen in a doctor's office. Over a period of about a year, they scanned the hearts of more than 2,000 fen-phen users.

Most of them were women in their 40s who were eager to lose weight and turned to fen-phen.

"They loved it," Flessas said. "They could get to their dress size. It made them not want to eat."

Marcella Sherrod, then 44, was one of those who turned to fen-phen. The Kenosha, Wisc., woman tried the drug for about 6 months and developed severe heart valve damage.

Sherrod was going to undergo heart valve replacement surgery in 2008, but her surgery was delayed after she got pneumonia. She died about a year later, at age 62.

Her husband, Robert, cautioned others about using weight-loss drugs.

"You really don't know exactly what you're taking," he said.

Last year, Sherrod's estate received a settlement of about $250,000, according to attorney Flessas. Hardy got $326,000 in settlement of her case.

Hardy did not need valve replacement surgery. In 2005, she had gastric bypass surgery and now weighs about 218 pounds.

She said anyone using weight-loss drugs should research the potential side effects.

"I didn't do that," she said. "I actually thought it was a miracle drug."

Coulter Jones contributed to this piece.