IA#66-36 --- 4/9/87
BACKGROUND
Effective March 28, 1987, danthron containing products may no longer be
marketed in the United States. Danthron is most often used in laxatives.
This decision was based on recent studies showing that chronic administration
of high doses of danthron to rats and mice resulted in the development of
intestinal and liver tumors and that danthron is, therefore, a potential cause
of cancer in humans.
A. Action Taken in the United States
The Food and Drug Administration has advised drug firms manufacturing
laxatives containing the drug danthron to immediately discontinue their
production and to recall them from retail store shelves.
Danthron toxicity in humans has not been specifically demonstrated but because
of the potential risk, FDA has requested a halt to all manufacturing,
relabeling, repacking and further distribution in the United States of human
drug products containing danthron as an ingredient.
B. Action Taken in United Kingdom and Germany
The United Kingdom's Committee on Safety of Medicine has advised manufacturers
of danthron-containing products of its concern regarding the potential
carcinogenic risk suggested by the rodent studies. Further, on January 28,
1987, the BGA (German Federal Health Administration) ordered eleven
pharmaceutical companies to withdraw twelve drug products containing danthron
from the market by the end of January, 1987.
GUIDANCE
Detention is indicated on all (Bulk, Rx and OTC) articles of drug offered for
human use that contain danthron.
Charge: "The article is violative within the meaning of Section 801(a)(3) in
that it is a "new drug" within the meaning of Section 201(p) of the Federal
Food, Drug, and Cosmetic Act, without an approved New Drug Application,
pursuant to Section 505(a)."
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