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How dangerous is fen-phen: the jury’s still out

This most recent study by Dr. Burger and his colleagues about the relationship between fen-phen and heart valve disease may be reassuring to the millions of people who took the diet drug cocktail before it was taken off the market in 1997.

In 1996 alone, the total number of prescriptions for the two drugs exceeded 18 million in the U.S., so many people have naturally been concerned about the long-term implications for their health. At this point, it is probably premature to draw any firm conclusions about a causal relationship. This study was well controlled, whereas many of the earlier reports were not, but we still have no long-term data, and many of the reports to date have been anecdotal and conflicting.

Other reports
In August 1997, a report in the New England Journal of Medicine first linked valvular heart disease with the use of fen-phen. The concern stemmed from a report by Mayo Clinic physicians, who found unusual heart problems in 24 women who had used fen-phen for an average of 12 months. Each had a thickening of one or more heart valves, which causes blood to leak back into the heart, making it work harder. Five of the women needed surgery to repair or replace the damaged valves.

In 1997, the FDA received independent echocardiographic surveys of patients from five geographic areas who had received fenfluramine alone or in combination with phentermine. The prevalence of valve disease meeting the FDA definition was similar in all five surveys and ranged from 30 to 38 percent. The prevalence increased with the duration of drug use. But there is no proof of a causal link, and it is not clear that the 113 cases reported to the FDA were representative of the estimated 4.2 million people who were taking the drugs.

A new study published in the November 23 issue of Circulation showed 7.6 percent of patients treated with the drug dexfenfluramine, which is very similar to fenfluramine, had either mild aortic valve disease or moderate mitral valve problems, compared to 2.1 percent who did not take the drug. Valve problems were detected at twice the rate among patients who had stopped treatment less than eight months before their echocardiogram compared with those who had been off the medicine for longer than eight months suggesting valve problems may regress after the drug is discontinued.

Despite several additional studies, there is still no consensus among cardiologists on the causal relationship between fen-phen and valve disease, which doesn’t offer those who took the drugs much reassurance.

What should you do if you’ve taken fen-phen?
I would recommend anyone who has taken fenfluramine or dexfenfluramine for any period of time should have a thorough medical history and cardiovascular physical examination, if they have not already done so.

It is possible to have valve disease and experience no unusual symptoms. In fact, the 15 subjects in the Burger study who were found to have valve disease had no obvious symptoms. Many healthy adults have mild valve leakage that poses no threat to their health. Your physician can listen for heart murmurs or detect valve abnormalities with an echocardiogram, which is particularly important if you do have unexplained symptoms such as easy fatigability, shortness of breath, palpitations or chest pain.

The fen-phen experience has confirmed the need to be cautious about medical treatments for obesity. There is no magic bullet to weight loss. Consistent lifestyle changes in diet and exercise are the only long-term solution, but research into the causes and possible treatments for obesity continues. It’s obvious that significant obesity is a very serious health concern in the U.S, and we’re hopeful that some of the genetic research into the body’s regulation of fat storage may result in some effective and safe treatments.

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Dr. Blum is a cardiologist on staff at Yale-New Haven Hospital and an assistant professor in the section of cardiovascular medicine at Yale University School of Medicine.