Area Clinics Unfazed by Suit Tied to Fen-Phen Use

Two days after a Massachusetts law firm filed what is believed to be the first wrongful death lawsuit involving the popular diet pills fenfluramine and phentermine, it was business as usual at Southern California weight-loss centers that prescribe the regimen.

At Manhattan Medical Weight Control in Los Angeles, founder and president Dr. Don Jensen on Wednesday said no patients had asked or expressed concern about the dangers of fenfluramine or phentermine.

The same was the case at the University Obesity Center at the UCLA School of Medicine, said Dr. Morton H. Maxwell, clinical professor of medicine and director of the center, which also prescribes the two-pill regimen along with a newer appetite suppressant, dexfenfluramine (Redux).

On Monday, attorney Alex H. MacDonald filed a wrongful death suit in Middlesex County Superior Court, Cambridge, seeking a jury trial and unspecified monetary damages on behalf of the parents of Mary Linnen, a 30-year-old West Quincy woman who began taking fen-phen in May 1996 to pare down her 5-foot-6-inch, 185-pound frame to better fit in her wedding dress for her upcoming October wedding.

“She took [the regimen] for 24 days,” according to MacDonald, adding that Linnen’s typical weight was about 140 pounds. And she was not warned, MacDonald said, about the potential side effect of primary pulmonary hypertension (PPH), a potentially deadly lung disorder. “She was symptomatic after 12 days,” MacDonald said.

Linnen was hospitalized on Nov. 14, MacDonald said, found to have PPH and then in December had a medical device surgically implanted to allow continuous administration of life-prolonging drugs, according to a press release released by MacDonald’s law firm, Robinson & Cole in Boston.

She died in February.

The suit names Wyeth-Ayerst Laboratories Inc., Medeva Pharmaceuticals Inc., A.H. Robins Inc., Dr. Abby Landzberg, the prescribing doctor, and Walgreen Co.

Since Monday’s announcement, “I’ve gotten three phone calls from women in Los Angeles who think they also have cases,” MacDonald said. He has also received telephone calls from dieters in other parts of the country.

Audrey Ashby, spokeswoman for Wyeth-Ayerst, which markets and manufactures fenfluramine, said Wednesday that she would not comment directly on the suit because “we have not been served with the complaint. The attorney has supplied the media with the complaint and the press release.”

But she did point out that in January, Wyeth-Ayerst sent out “Dear Doctor” letters to 470,000 health care professionals nationwide, warning them that “Concomitant use of Pondimin (fenfluramine) with other weight loss agents is not recommended. The addition of phentermine to Pondimin is not an approved use of Pondimin.”

While both drugs have been approved for years by the Food and Drug Administration, the combination regimen is not approved.

“We don’t know the cause of PPH,” UCLA’s Maxwell said, noting that studies have shown only “an association” between the use of dexfenfluramine or fenfluramine and PPH. In a study published in the New England Journal of Medicine in 1997, Dr. Lewis Rubin of the University of Maryland, a pulmonary expert, found a more than twentyfold increase in the risk of PPH among those who took appetite suppressant for more than three months, including fenfluramine, but the study did not examine the fen-phen combination.

Anne Kearney-Cooke, a psychologist and body image specialist at the Cincinnati Psychotherapy Institute, acknowledged that it is “painful” for people to be overweight but says more research on the diet pill combination is clearly in order. “Until research [on drug regimens] is more conclusive, eating healthy and exercising does seem to improve body image and regulate mood and help people to feel better,” she said.

In Maxwell’s view, dieters who want to take the pills should “go to someone skilled” in their use who prescribes the lowest possible doses and provides close monitoring.

Across the nation, pharmacy boards and legislators are reevaluating restrictions on the diet drugs. In California, a bill introduced by state Sen. Ross Johnson (R-Irvine) passed the Senate and is now in the Assembly. It would lift the restrictions on fenfluramine by deleting it from the Schedule IV of the controlled substance list, conditional on the federal government taking the same action. In California, prescriptions for Schedule IV drugs are valid for only six months after they are written and have restrictions on refilling, said Virginia Herold of the California State Board of Pharmacy.