Diabetes Drug May Be Linked To 500 Deaths

PARIS — French health officials said Tuesday the now-banned diabetes and weight loss drug Mediator may have been linked to the deaths of about 500 people in the 33 years it was on the market.

France's health products safety agency has advised those who used the drug from 2006 to 2009 to see their doctor to check for possible heart valve problems.

The agency said Tuesday that about 5 million people used Mediator – the brand name for benfluorex in France – from 1976 until it was pulled off the market in 2009.

The European Medicines Agency said last year that it decided to remove benfluorex from the market because it had little effect on diabetes and might lead to a dangerous thickening of heart valves.

In September, European regulators pulled blockbuster diabetes drug Avandia off the market because of alleged links to heart attacks.

Benfluorex, used especially to treat weight problems among diabetics, underwent various tests over time, but it was only in 2006 that a confirmed case of heart valve problems related to its use was reported, the health safety agency said.

A complementary study was carried out last summer to determine what impact benfluorex had on patients who took the drug in 2006. It followed their hospitalizations and deaths linked to heart valve problems until June of 2010.

"On the basis of results, the analysis by epidemiologists believe that around 500 deaths may be attributable to benfluorex among all users of the medication since it went on the market," the health products safety agency said.

The drugmaker, Servier, which has carried out its own tests, said the results were an "extrapolation."

"The Servier Research Group underscores that these figures are hypotheses founded on extrapolations," the drugmaker said in a statement

Heart valve problems naturally affect some 2.5 percent of the population, a figure that increases with age and the presence of diabetes, Servier said. It argued that the test does not allow one to blame all valve problems on the medication.

Servier, however, counseled patients to discuss the issue with their doctors as "a precaution."

(This version CORRECTS spelling of benfluorex throughout.)

Comments

[J David Auner]

03:29 PM on 11/17/2010

Article is not organized to provide real information. Beneflorex (sp?) is probably related to stimulant meds previously shown to cause heart valve defects and more importantly pulmonary hypertension. This is not surprising given the high incidence of problems with Redux and others. The lack of improvement in diabetes is also not surprising.
The comment about Avandia has no place in this article. When we look back at Avandia, I think it will be clear that all diabetics need careful therapy to prevent clots. I used Avandia with antiplatelet agents and never had a clot in hundreds of patient years experience. Avandia is not related in any way to stimulant drugs which have been bad actors.

[Marjorie Bard]

05:36 AM on 11/17/2010

As a longtime researcher in the area of the differences between urban and rural health care (and lifestyle), I can state that when I lived in a major West Coast city, the physicians, especially internists and endocrinologists, were as up to date on meds as anyone can be. But in the rural area in which I live now on the East Coast, I have been told to take at least 5 diabetes meds, including Avandia, Januvia, Zetia, Prevacol, and Lipitor -- all of which induced such serious deleterious effects that I have some lasting damage. Januvia caused deep pain and "tingling" in my legs, and the soles of my feet could not even touch the floor. The others quickly caused muscle spasms, numbness, and headaches. When I noted the negative effects of these meds, I was told that I am "not following orders" and find that my charts state that I am noncompliant. Naturally, this affects the way I am seen when attempting to find a specialist in the nearest major city.

Do I feel comfortable with my current diabetes drug? No. What will studies show in 5 years?

I understand this situation, for I have heard the same complaints from rural patients across the country. It appears that the study of the differences between urban and rural heatlth care needs to be discussed as a national issue. It is not just one person wishing for more educated M.D.s. It is an American problem, and it should be identified as

[stape45]

10:41 PM on 11/16/2010

As a diabetec drug user myself, I'm glad it wasn't marketed in America, because it would probably have remained on the market for years as long as it was making a healthy profit, and the death toll could have been very high.

[stape45]

10:44 PM on 11/16/2010

If I were not a diabetic, I would of course, be concerned for those whose lives or health were threatened, whether it was a personal issue for me or not. Just wanted to clarify that.