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FDA Warns Hospitals of DEHP Exposure
Chemical Week July 24, 2002 SECTION: REGULATORY; Phthalates;
Pg. 35
BYLINE: NEIL FRANZ in Washington
FDA has issued a public health
recommendation that hospitals limit exposure of male fetuses and
newborns to
polyvinyl chloride (PVC) medical devices that contain di(2-ethylhexyl)
phthalate
(DEHP) plasticizer. The move follows a 2001 FDA safety assessment
of DEHP,
which found that the additive poses a risk to male infants who
have prolonged
exposures (CW, Sept. 12, 2001, p. 13). Tests found that DEHP may
harm the
development of reproductive systems in young, male laboratory
animals, FDA says.
The agency suggests, but does not require, that several medical
procedures are
performed with alternatives to products with DEHP. These include
PVC devices that
do not contain DEHP, as well as devices made from other materials,
such as
ethylene-vinyl acetate, silicone, polyethylene, or polyurethane,
FDA says. The
procedures include feedings and transfusions that use intravenous
(IV) bags. FDA
recommends considering alternatives when the procedures are to
be performed on
pregnant women carrying male fetuses, male newborns, or pubescent
males, says
David Feigal, director/Center for Devices and Radiological Health
at FDA. Health
and environmental advocacy groups criticize the FDA recommendation,
however,
because there is no requirement that manufacturers label PVC medical
devices that
contain DEHP. Some medical manufacturers are voluntarily labeling
phthalate
ingredients in their products, activists say.
"FDA's notification falls short of what is needed to protect
patients," says the group
Health Care Without Harm (Washington). Industry disputes the agency's
risk
assessment of DEHP. FDA's conclusions from tests on rodents do
not mean that
humans face the same risk from DEHP exposure, says ACC's phthalate
esters panel.
No human studies exist that show similar effects, the panel says.
Tests on primates, which are better indicators of risks to humans,
show that primates
are "much less susceptible" to the effects found in
male rodents, it says. GRAPHIC:
Picture, Health concern: IV bags may pose a risk.
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