Import Alert 66-36
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-36
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Human Drugs Containing Danthron"
Reason for Alert:
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.
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 without physical examination is indicated on all (Bulk, Rx and OTC) articles of drug offered for human use that contain danthron.
Product Description:
Danthron containing products. Danthron is most often used in laxatives.
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)."
OASIS Charge Code - UNAPPROVED
OASIS Charge Code - UNAPPROVED
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(63 H - - 09) Danthron (Cathartic)
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