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 ollowing the release of a comprehen- sive study of
the scientific literature on di-ethylhexyl phthalates (DEHP),
a coalition of more than 180 health, religious, labor and environmental
organizations today petitioned the FDA to warn patients and health
care providers about the potential health risks from this toxic
chemical.
 More
than 500 million IV bags are used in the United States every
year to deliver blood, medication and other essential fluids
to sick and injured patients. Eighty percent of these are made
of polyvinyl chloride (PVC), which requires a plasticizer to
make them soft and flexible. DEHP -- the softener used in PVC
products -- has been shown to leach from IV bags into the solutions
they contain and directly into patients.
The peer-reviewed
report, released today by the University of Massachusetts' Lowell
Center for Sustainable Production, evaluated more than 100 studies
on DEHP. The review confirmed that the toxic chemical leaches,
potentially causing damage to the heart, liver, ovaries, testes,
lungs and kidneys, and interfering with sperm production.
The Lowell
report was commissioned by Health Care Without Harm (HCWH), the
same coalition who today called on the FDA to take the following
actions:
- Require all PVC medical devices that leach
plasticizers to include a warning label and additional information
on the potential health risks caused by DEHP leaching and FDA-approved
alternatives.
- Warn pregnant women, infants, hemophiliacs,
dialysis patients and others receiving long-term intravenous
or tube-feeding treatment that they are more likely to receive
high doses of DEHP.
- Expedite the development of safer, PVC-free
alternatives to all PVC medical devices that leach plasticizers.
While
the FDA has not set any limits on plasticizer leaching from medical
devices, the agency does restrict the amount of plasticizer to
30 percent of the weight of food containers. PVC IV bags, blood
bags and tubing all contain more than 30 percent DEHP by weight.
"Current
FDA regulations make no sense," said Charlotte Brody, RN
and Co-Coordinator of HCWH. "Why should plastic food containers
be regulated more strictly than plastic medical products? And
why should the FDA warn cancer patients of DEHP leaching with
certain medications, but not infants or hemophiliacs, who may
be even more exposed?"
The medications
Brody refers to include the chemotherapy drugs Taxol and Taxotere,
which come with warnings from the drug manufacturer against using
PVC equipment for their administration because of increased leaching
of DEHP.
HCWH's petition
comes in the wake of increased public scrutiny of DEHP's use
in vinyl IV bags, children's toys and certain other flexible
PVC medical products. It also precedes two other reviews of DEHP.
One will be released by the American Council on Science and Health,
whose panel is chaired by former Surgeon General Koop. Another
by the FDA itself will be released later this year.
"Humans
are exposed to substantial levels of DEHP through medical devices"
said Joel Tickner, the primary author of the Lowell DEHP report.
"Given this exposure, along with other health and environmental
concerns of PVC, it's important to investigate alternative materials
for medical purposes."
Indeed, an
increasing number of hospitals and medical equipment providers
are phasing out PVC products and replacing them with safer alternatives.
Recent examples include Baxter International, Inc., the nation's
leading producer of IV bags; Universal Health Services, Inc.,
the country's third largest hospital management company; and
Kaiser Permanente, America's largest nonprofit health maintenance
organization.
In addition
to disclosing the susceptibility of patients to DEHP exposure,
the coalition noted that vinyl IV bags have a high chlorine content.
Consequently, vinyl manufacturing and disposal by incineration
create dioxin -- one of the world's most toxic chemicals. 
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