P97-3 Food and Drug Administration
FOR IMMEDIATE RELEASE
Jan. 15, 1997
Consumer Hotline (800) 532-4440
WARNINGS REQUIRED ON IRON-CONTAINING DRUGS AND SUPPLEMENTS
FDA today announced rules to protect children from
accidental poisoning from iron-containing drugs and dietary
supplements. These products must now bear a label warning
statement, and in addition, products containing 30 milligrams or
more iron per unit must be packaged as individual doses that will
limit the number of pills or capsules a small child could readily
consume.
Accidental overdose of iron is a leading cause of poisoning
deaths in children under six, despite child-resistant packaging.
Since 1986, more than 110,000 incidents of children ingesting
iron have been reported, and 35 children have died.
"Even one child poisoning is too many, particularly if it
can be prevented," said Food and Drugs Commissioner David A.
Kessler, M.D. "Parents, care-givers and grandparents the
children may visit need to know that iron-containing products can
be toxic in large doses, and even fatal, if swallowed by a small
child."
Packages of all preparations that contain iron or iron salts
for use as dietary iron supplementation or for therapeutic
purposes must now display -- in a prominent and conspicuous place
set off by surrounding lines -- the following statement:
"WARNING: Accidental overdose of iron-containing products
is a leading cause of fatal poisoning in children under six.
Keep this product out of reach of children. In case of
accidental overdose, call a doctor or poison control center
immediately."
Most of the serious injuries have occurred with products
having more than 30 mg of iron per dosage unit. This includes
most prenatal iron products, which are likely to be found in
households with young children. FDA has determined that
individual-dose packaging, such as a blister pack, would limit
the number of capsules or tablets a child could consume if he or
she accidentally gained access to such products.
In 1978, the U.S. Consumer Product Safety Commission (CPSC)
adopted regulations requiring iron-containing products with more
than 250 mg of total iron per container be packaged in child-
resistant containers. However, in some poisoning cases young
children had been left unattended in the presence of uncapped
containers. FDA and a consensus of public health officials and
industry groups hope that the additional safeguards, together
with greater public awareness of the problem, will reduce the
incidence and severity of pediatric iron poisonings.
####
This is a mirror of the page at
http://www.fda.gov/bbs/topics/NEWS/NEW00552.html