The Benfluorex Scandal: Effective ADR monitoring and post-marketing surveillance could prevent tragedy.
Benfluorex is an appetite suppressant drug. It is also used to lower
the levels of blood lipids and lipoproteins. It has been claimed to help
in the improvement of glycemic control and play a role in decreasing
insulin resistance in the patients of type 2 diabetes mellitus .
Primarily used for treating diabetes, benfluorex has been used off-label
for reducing obesity .
France's national health-insurance organization (CNAM) suspected its
involvement in 500 deaths and at least 3500 hospitalizations in France
since 1979. CNAM reported the same to the French Agency for Safety of
Health Products (AFSSAPS). Several investigations have pointed to the
possible 'lethality' of benfluorex .
Recently, AFSSAPS has advised the people having used this drug from 2006
to 2009 to undergo medical examination to rule out the possibility of
heart valve problems .
The European Medicines Agency (EMEA) - the organisation entrusted with the
monitoring of drugs for use in European Union - has recently recommended
the withdrawal of all benfluorex medications in the EU countries .
French doctors have correctly raised the issue of this drug with the
government . It is really surprising to note that such a drug was able
to stay in the French market for 33 long years. It also points out that
something is missing in the ADR monitoring and post-marketing surveillance
studies results. No studies or investigations can ever compensate for the
loss of human life attributable to benfluorex and the apathy of the people
associated with monitoring of this drug. Such demands and studies can at
least prevent the repetition of medical tragedy of this magnitude.
1. Webpage : http://www.greenliveforever.com/tag/benfluorex accessed on
Jan 30, 2011.
2. Webpage: http://www.theheart.org/article/1154259.do accessed on Jan 30,
3. Webpage: http://www.huffingtonpost.com/2010/11/16/weight-loss-drug-
diabetes_n_784155.html accessed on Jan 30, 2011.
4. Webpage: http://thassodotcom.wordpress.com/2009/12/31/european-
in-european-union011 accessed on Jan 30, 2011.
5. Benkimoun P. French doctors demand to know why drug stayed on the
market for so long. BMJ 2010; 341:c6882.
Competing interests: Pharmacy Teaching at UG and PG level.