Popular French Weight Loss Drug Killed and Harmed Thousands

Losing weight
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A recent study confirms that a popular French weight loss drug has killed and harmed thousands of users over the past 30 years.

The weight loss drug benfluorex, known under the brand name “Mediator,” was a popular French weight loss drug that was pulled from the market three years ago amid claims of scandal and malfeasance that the weight loss drug resulted in the deaths and hospitalizations of thousands of users.

Mediator was derived from a previously popular weight loss drug in the U.S. known commonly as “Fen-phen,” that was pulled from the U.S. market in 1997. Studies showed that up to 30% of fen-phen users developed heart valve damage, and in some cases—pulmonary hypertension. Fen-phen was a weight loss cocktail of the three diet drugs fenfluramine, dexfenfluramine and phentrimine; estimated to have been used by over 6 million Americans. Today, more recent research warns U.S. consumers of three current weight loss drugs.

Mediator was originally slated to be prescribed for diabetes patients to reduce lipids in the blood and help control blood-sugar levels. However, it was later revealed that the pharmaceutical maker’s designation of Mediator as a dug for treating diabetes was a ploy to evade scrutiny by health officials. Mediator’s use as a weight loss drug for non-diabetics was a “well-known secret” as sales reps encouraged physicians to prescribe Mediator for patients who wanted to lose weight.

Furthermore, Mediator’s removal from the market revealed that France’s drug licensing agency that approved Mediator and many other drugs had serious conflicts of interest with members who served as consultants with French pharmaceutical companies.

Lead author Mahmoud Zureik, MD, PhD states that, "Despite its similarity with the two appetite suppressants fenfluramine and dexfenfluramine, benfluorex was kept on the market for more than 30 years in France. French citizens, practitioners, politicians, and public health actors were seeking to understand why the French health products safety agency took so long to withdraw this drug which was of very limited efficacy and was dangerous."

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Currently, the maker of Mediator— French manufacturer, Servier—is under investigation for consumer fraud, manslaughter and defrauding the French health care system.

However, just how damaging Mediator was to public health is in question and is being investigated by researchers at the French National Institute of Health and Medical Research.

In a recent study published in the journal Pharmacoepidemiology and Drug Safety, Zureik and colleagues have analyzed data gleaned from sources that include sales figures of benfluorex, benfluorex-associated relative risk of hospitalization for valvular insufficiency, the number of hospitalizations for valvular insufficiency among individuals who were benfluorex users in 2006 and mortality figures from valvular insufficiency in France.

According to their calculations, an estimation of 3,100 hospitalizations and 1,300 deaths due to valvular insufficiency are attributed to the use of the weight loss drug Mediator during the period of 1976-2009. The investigators believe these numbers reflect the minimum number of individuals affected by the drug and that many more have suffered from its use.

The result of the banning of this popular French weight loss drug that has killed and harmed thousands of users over the past 30 years is that France is now changing some of its rules in its drug regulatory system that includes sanctions against drug licensing agency committee members who fail to declare conflicts of interest as well as limitations on interactions between doctors and drug companies. Unlike the ability for U.S, citizens to enter class action lawsuits, as has been done with fen-phen, the French system does not have a similar redress for their nation’s weight loss drug victims and family members.

Image Source: Courtesy of MorgueFile

Reference: “Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France" Pharmacoepidemiology and Drug Safety; published online: 9 Feb. 2012; Agnès Fournier and Mahmoud Zureik

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