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Testimony on Bupropion and Naltrexone (Contrave) Safety

Testimony of Sammy Almashat, M.D., M.P.H. and Sidney Wolfe, M.D.
Public Citizen Health Research Group
Before the FDA Endocrine and Metabolic Drugs Advisory Committee

View testimony as a PDF.

1 Astrup A. Is cardiometabolic risk improved by weight-loss drugs? Lancet. 2010 Aug 21;376(9741):567-8. Epub 2010 Jul 29.
2  Fishman AP. Aminorex to Fen/Phen: An Epidemic Foretold. Circulation. 1999;99:156-161. Web. Accessed on December 6, 2010. http://circ.ahajournals.org/cgi/content/full/99/1/156
3 FDA. Questions and Answers about Withdrawal of Fenfluramine (Pondimin) and Dexfenfluramine (Redux), 9/18/1997 (updated: 7/7/2005) Web. Accessed on December 6, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm180078.htm
4 Br Heart J. 1993 Dec;70(6):537-41. Primary pulmonary hypertension and fenfluramine use. Brenot F, Herve P, Petitpretz P, Parent F, Duroux P, Simonneau G.
5 FDA Press Release, Feb. 6, 2004. FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products. Web. Accessed on December 6, 2010. http://web.archive.org/web/20080223161240/www.fda.gov/bbs/topics/NEWS/2004/NEW01021.html
6 James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL; SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17.

Bupropion has documented effects on blood pressure and heart rate. As the Label points out…

Contrave caused higher rates of elevated systolic blood pressure, rapid heart rate and palpitations in the Phase III trials.

Similarly, prior to approval, Sibutramine had the same three increases in these cardiovascular risk factors. These were the reasons that both the Medical Officer and Advisory Committee were opposed to approving the drug at the time.

This was one of 3 myocardial infarctions in those receiving Contrave. In this case, the FDA Reviewer noted that “…it is concerning that his systolic blood pressure increased despite significant weight loss”.

After the ban of Sibutramine in the UK, an editorial stated that…