E-drug: Proposed ban for diet drug sibutramine
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March 19, 2002
Tommy Thompson, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Thompson,
Public Citizen, a nationwide consumer organization, with a
membership of more than 130,000, petitions the FDA, pursuant to the
Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and
21 C.F.R. 10.30, to immediately ban the unacceptably dangerous
prescription diet drug Meridia (sibutramine, Knoll
Pharmaceuticals/Abbott). According to the FDA data base, since its
launch in early 1998 sibutramine has now been associated with 29
deaths including 19 from cardiovascular adverse effects in people
using this minimally effective drug. Two weeks ago, its use was
suspended in Italy because of two cardiovascular deaths and its
safety is currently under review in other European countries where,
in the UK and France alone, there have been a total of 103 serious
adverse reaction reports in people using the drug including two
deaths in Britain.
Prior to its approval in 1997, a FDA advisory committee voted five to
four that the benefits of sibutramine did not outweigh the risks. The
FDA medical officer who reviewed the drug wrote that "sibutramine has
an unsatisfactory risk-benefit ratio and therefore this Reviewer
recommends non-approval of the original submission". The concern of
both the advisory committee and the FDA medical officer was based on
the fact that sibutramine significantly increases blood pressure and
heart rate in many people. When announcing its seriously mistaken
approval of sibutramine in November, 1997, the FDA stated that the
average weight loss in obese people taking the drug for one
year-beyond the weight loss in those getting a placebo---was only 6 �
pounds in the group taking 10 mg of the drug.
This is the fifth petition we have filed with the FDA to ban a drug
since 1996. The last four were for the diet drug Redux (banned
September, 1997 after our April, 1996 petition), the diabetes drug
Rezulin (banned in March, 2000, one year and eight months after our
July, 1998 petition), the antibiotic Trovan (severely restricted in
the US and banned in Europe in June, 1999 after our earlier June
petition), and Lotronex, a drug for irritable bowel syndrome (banned
in November, 2000, three months after our August, 2000 petition). For
all of these other four drugs, as with sibutramine, there was also
clear evidence of danger before FDA approval.
(for the remainder of the petition---go to our web site: Citizen.org/hrg)
Sidney M.Wolfe M.D.
Director, Public Citizen's Health Research Group
1600 20th St. NW, Washington, DC. 20009
202 588-7735 fax 588-7796
e-mail swolfe@citizen.org
Web site: www.citizen.org/hrg
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