Many American consumers have been upset in the last decade that the FDA has continually banned or prevented the release of newer weight loss drugs in the United States. However, after reading the news from France, the FDA deserves a lot of credit.
Data just released from French investigators reveals that the use of benfluorex (Mediator) as a weight loss drug was not innocuous. The number of deaths attributed to heart valve leakage as a result of the drug is much greater than what the French authorities initially reported.
It is estimated that close to 1300 people have died from a leaking heart valve after use of benfluorex. And in all likelihood, the researchers say, these numbers are grossly underestimated. (1)
Even though benfluorex has very similar structural and chemical similarities to the appetite suppressants, fenfluramine and dexfenfluramine, the drug was allowed to be sold in France for the past 30 years. The grave consequences have now led to a public investigation and the need for much stronger drug regulation.
The French Agency for Safety of Health Products is under serious scrutiny for allowing the sale of benfluorex in France long after it had been pulled from the market in most of Europe.
Worst news is that many non-French visitors may have bought the drug for weight loss and there is no way of following up on these people.
Benfluorex was introduced in France in the 1970s as an adjunct treatment for high cholesterol and obesity in patients with type 2 diabetes. Although the drug was a potent appetite suppressant, it was used off-label to lower cholesterol in type 2 diabetics.
Even though reports of fenfluramine toxicity were in the news in the 80s and 90s, the French authorities did not re-evaluate benfluorex. By the 1990s, most Europeans withdrew fenfluramine from the market but the French allowed benfluorex to be sold until 2009.
The exact number of deaths will not be known because a lot of time has passed. However, researchers are now looking at the sales figures and reassessing hospitalizations for valvular leakage in French patients over the past 20 years. (2)