Planning for an active retirement, Norma Moore got a prescription for the diet drug Meridia last summer to lose weight. Two months later, she died unexpectedly. Her daughter Helen describes her symptoms.
"Increased blood pressure ... She was, that day, having problems breathing," said Helen Stout. "She had a clean bill of health prior to that, even though she was overweight."
Meridia's maker, Abbott Laboratories, says there's no proof their drug is to blame. But a watchdog group, Public Citizen, claims Meridia is linked to 29 deaths in the United States and wants it off the market, reports CBS News Correspondent Sharyl Attkisson.
"The drug should not have been approved. Both the FDA's advisory committee and the doctor at the FDA that worked on the drug thought that it was too dangerous to be approved," said Dr. Sidney Wolfe, with Public Citizen.
Despite that advice, the FDA approved Meridia in 1997— with a caution for people with blood pressure or heart problems. It's one of a number of drugs critics say are dangerous, but rushed to market by an FDA that's too cozy with the pharmaceutical industry.
Millions have now used Meridia. Global sales reached $200 million last year. The television ads are familiar: "Your doctor has something that may help you eat less. It's called Meridia ... One pill, once a day."
Obesity specialist Dr. Arthur Frank, who has consulted for Abbott Labs, says Meridia is completely safe as long as patients are closely watched.
"The complications from Meridia tend to be easy to identify, like high blood pressure. And if a patient develops high blood pressure, you stop taking it!"
Others aren't so sure it's that simple. The sale of Meridia was suspended in Italy in March after two women died there. The head of Abbott Labs — who declined to be interviewed for this report — spoke earlier about Italy's decision.
"Unfortunately, Italy reacted to the problem a little too quickly, without the complete data,'' said Dr. Jeffrey Leiden, president and COO of Abbot Laboratories in a March 21, 2002 interview on CBS' The Early Show.
Compounding the debate over Meridia's safety are new charges that Abbott labs concealed crucial data. The law requires drugmakers to report severe drug reaction to the FDA. But in a recent report, FDA inspectors found Abbott failed to disclose one death, and gave false or misleading information on others.
Abbott insists Meridia is safe, that its reporting has been appropriate, and the "alleged unreported death" was just a "rumor ... (that) Abbott was unable to substantiate."
But the FDA says it's seriously investigating each of the allegations. One dilemma is that obese people are at risk for heart and blood pressure problems to begin with. So it's hard to tell when Meridia might be to blame. To find out, sources say FDA scientists have begun comparing the deaths of Meridia patients to (those of people on) other diet drugs.
Norma Moore's daughter isn't waiting for the FDA's findings. She's already convinced her mother 's use of the drug Meridia in her fight to lose weight cost her her life.
"From Day One, I have always felt that it was Meridia," said Stout.