E-DRUG: FDA proposes ban on popular laxative ingredient
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Dear E-druggers,
Today, the U.S. Food and Drug Administration proposed a ban on
a popular laxative ingredient phenolpthalein. Phenolphthalein is
available in different preparations either as a single ingredient
or as multi-ingredient preparations. Popular brand names include
Agarol, Alophen, Correctol (Ref Martindale: the extra
pharmacopeia 31st ed. 1996 p.1235-6.)
I would appreciate if e-druggers from around the world, please
email me the brand names, manufacturers' names of all
phenolphthalein-containing products in their countries, if
possible. Many thanks.
The FDA press release follows.
Syed Rizwanuddin Ahmad
Email: srahmad@essential.org
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P97-30 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Susan Cruzan: (301)827-6242
August 29, 1997 Broadcast Media: (301)827-3434
Consumer Hotline: (800)532-4440
FDA PROPOSES BAN ON OTC SALE OF LAXATIVE INGREDIENT
FDA is proposing to ban the over-the-counter (OTC) sale of
phenolphthalein, an ingredient widely used in laxatives, because
it may pose long-term safety concerns. The proposal would
require that products containing this ingredient either be
reformulated or withdrawn from the market.
The proposal to reclassify phenolphthalein as unsafe is
based on a review of animal carcinogenicity studies carried out
under the National Toxicology Program (NTP) and presented at a
recent FDA meeting. Although epidemiological human data has not
revealed any reports of cancer in humans related to the use of
phenolphthalein, the animal studies indicate a potential cancer
risk to people who use this ingredient at higher than recommended
doses or for extended periods of time.
Specifically, the two year studies showed that rats and mice
which were fed high doses of phenolphthalein -- approximately 50
to 100 times the recommended dose for humans -- developed a
variety of tumors. Other studies have shown that when mice were
fed high doses of the same chemical for six months at 30 times
the recommended human dose, they also developed tumors, as well
as genetic damage.
After reviewing this and other data, the FDA committee
concluded that phenolphthalein, which has been used in several
products for many years, potentially could cause cancer in
humans. Because consumers have access to more than two dozen
laxative products without this ingredient, FDA believes that
phenolphthalein's benefits do not outweigh its risks. In today's
Federal Register, the agency is proposing to reclassify
phenolphthalein as a Category II ingredient, or an ingredient not
generally recognized as "safe and effective".
Some manufacturers have recently reformulated their products
with other laxative ingredients. Consumers are advised to read
OTC laxative drug product labels carefully to be informed of
changes in the active ingredients. The Nonprescription Drug
Manufacturers Association has adopted a voluntary program called
"Flag the Label" to aid consumers in recognizing when major
changes have occurred in OTC drug products. This flag on the
label alerts consumers to read the new label information.
Today starts a 30-day comment period on the new proposal.
A final regulation will be issued following a review of the
comments, which can be sent to Dockets Management Branch,
HFA-305, RM 1-23, 12420 Parklawn Drive, Rockville, MD 20857.