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Woman’s death raises questions about diet pill ‘cocktail’

May 7, 1997 GMT

NEW YORK (AP) _ Drug maker Wyeth-Ayerst Laboratories Inc. warned doctors that making a popular ``cocktail″ out of its appetite suppressant drug was not recommended and not approved by federal regulators.

But doctors remain free to prescribe the mixture known popularly as fen-phen _ and did so 7 million times last year.

Now scrutiny of the cocktail has been heightened after the family of Mary Linnen, who took the diet drugs to fit into her wedding dress, sued the drug makers, a Walgreen’s pharmacy and the doctor who prescribed it.

The Food and Drug Administration has never approved the drug cocktail made with Wyeth-Ayerst’s fenfluramine and the competing drug, phentermine.

But the combined drug, banned in Sweden, is popular at weight-loss centers such as Nutri/System, whose doctors wrote several thousand fen-phen prescriptions last year, company spokesman Joseph DiBartolomeo said.

Monday’s lawsuit rekindled debate over its risk.

Ms. Linnen, of Quincy, Mass., died in February of a heart and lung disorder her family attributes to fen-phen.

``Instead of walking down the aisle before a bride, I walked behind a casket,″ said Mary Jo Linnen, mother of the the 30-year-old woman, who was 5-feet-6 and weighed 185 to 195 pounds.

Studies show the drugs taken separately cause primary pulmonary hypertension, an elevated blood pressure of the lungs that can cause the heart to fail _ the official cause of Ms. Linnen’s death.

But because the drugs were not meant to be taken together, there is no authoritative research to gauge the risk of taking fen-phen.

``There’s no question that fen-phen produces primary pulmonary hypertension,″ said Dr. Lewis Rubin, director of pulmonary and critical care at the University of Maryland Medical System in Baltimore. ``There is no question that either drug alone can produce pulmonary hypertension. What we don’t know at this point in time is the magnitude of the risk of taking the drugs together.″

Rubin, who advised Ms. Linnen’s family on her health in late 1996, co-wrote a New England Journal of Medicine study on the link between PPH and appetite suppression. The study, conducted in Europe, found a 23-fold increase in risk of PPH among those who took appetite suppressants, including fenfluramine. The study did not examine the fen-phen combination.

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Rubin and researchers at 15 medical centers are trying to persuade manufacturers, including Wyeth-Ayerst, to study the effects of fen-phen, Rubin said.

Wyeth-Ayerst, a division of American Home Products, has recently faced increased scrutiny over another diet drug, Redux. Studies in animals show high doses of Redux destroy brain cells, considered vital for mood and other functions. The company has vowed to study the drug.

Wyeth-Ayerst spokeswoman Audrey Ashby said the company had not seen the suit and would not comment on it. Because the fen-phen combination is not approved, the company does not recommend it, she said.

The Linnens’ lawsuit against the company also names phentermine maker Medeva Pharmaceuticals Inc. of London, pharmacy owner Walgreen Co. of Deerfield, Ill., and Dr. Abby Landzberg of Weymouth, Mass., who prescribed the drug.

Landzberg declined to comment and Medeva did not return calls.

Despite increased scrutiny, fen-phen has a substantial cadre of supporters.

``We’ve seen very few if any side effects,″ Nutri/System’s DiBartolomeo said. ``I think the history shows the drugs are very safe considering they’ve been on the market for over 24 years now.″

Victor Tapson, medical director at the Duke University Medical Center Lung Transplant Center, noted that obese people tend to die earlier and suffer increased rates of illness due to the added strain on their hearts and other organs.

``The risk of these drugs in someone in whom they’re indicated _ someone obese _ is quite minimal,″ he said. ``It doesn’t mean we want to use them without discretion. It’s not for patients who are just a few pounds overweight.

``There’s no doubt that if you use a drug that leads to significant weight loss in someone obese, you can reduce the mortality and morbidity in this way,″ he said.