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Table 3 Profile of centrally acting anti-obesity products withdrawn because of associated deaths over the last 50 years

From: Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review

Aminorex
• First introduced in 1962
• Became available within 3 years of introduction as an over-the-counter weight loss pill
• Between 1965 and 1972, there was an alarming increase in the incidence of primary pulmonary hypertension [52]
• The pulmonary hypertension epidemic ended in 1972 following the withdrawal of aminorex from the market
 
Benfluorex
• Approved in 1976 as an add-on treatment in obese patients with diabetes mellitus
• Cases of valvulopathy attributed to its use began to appear from 2003
• Was withdrawn in 2009 following an epidemic of valvulopathy attributed to its use
• Several deaths reported
• To date, more than 3000 hospitalizations and at least 1300 deaths attributed to its use in France alone [53]
 
Fenfluramine
• First approved in in 1973
• Reports of pulmonary hypertension first appeared in 1981
• Several other case reports subsequently published
• Epidemiological studies showed an association between fenfluramine and pulmonary hypertension [54]
• Withdrawn worldwide in 1997
 
Methamphetamine (desoxyephedrine)
• First introduced in 1944
• Within 10 years of its introduction, cases of its misuse had been reported
• By the early 1970s, reports of its abuse as an anorectic were reported [55]
• Was withdrawn in the USA and other countries in 1973
• Several cases of cardiac abnormalities related to its abuse have subsequently been reported
 
Phentermine
• First approved in 1959
• Several cases of lung phospholipidosis in animals and humans reported thereafter
• Reports of death began to appear in 1974 [56]
• Withdrawn from most countries where it was marketed in 1981
• Still available for short-term management of obesity in the USA
 
Rimonabant
• Approved in Europe in 2006 for obesity treatment
• Within 1 year of approval, concerns were expressed about the risk of depression and suicide associated with its use [57]
• Five deaths attributed to its use in the UK [58]
• Was withdrawn in 2007
 
Sibutramine
• Approved in 1997 in the USA and Europe in 2001
• Within a year of its European approval, serious cardiovascular adverse reactions were reported, resulting in temporary withdrawal in Italy [59]
• Several cases of severe cardiovascular adverse reactions, including deaths, were subsequently reported [60]
• Withdrawn in Europe and USA in 2010
 
  1. Fishman AP. 1999 [52]
  2. Fournier A, Zureik M. 2012 [53]
  3. Connolly HM, Crary JL, McGoon MD, Hensrud DD, Edwards BS, Edwards WD, Schaff HV. 1997 [54]
  4. Ladewig D, Battegay R. 1971 [55]
  5. Price K. 1974 [56]
  6. Gadde KM. 2006 [57]
  7. World Health Organization. 2008 [58]
  8. Anonymous. 2002 [59]
  9. Wooltorton E. 2002 [60]