FDA petitioned on DEHP hazard
Following the release of a study of the scientific literature on diethylhexyl phthalates (DEHP), a coalition comprised of health care, religious, labor, and environmental organizations has petitioned the U.S. Food and Drug Administration (FDA) to warn patients and health care providers about potential health risks from this toxic chemical.
DEHP is a plasticizer/softener used in PVC (polyvinyl chloride) products. More than 80% of the more than 500 million IV bags used to deliver blood, medication, and other essential fluids are made of PVC. DEHP has been shown to leach from IV bags into the solutions they contain — and from there into patients.
The peer-reviewed report, released June 15 by the University of Massachusetts’ Lowell Center for Sustainable Production in Lowell, MA, evaluated more than 100 studies of DEHP. The report confirmed that the toxic chemical leaches, potentially causing damage to internal organs and interfering with sperm production.
The Lowell Report was commissioned by Health Care without Harm (HCWH), an organization whose members include 41 hospitals, the American Nurses Association, the American Public Health Association, The Sierra Club, and a number of other groups.
HCWH has called on the FDA to require all PVC medical devices that leach plasticizers to include warning labels providing information on health risks; to warn those receiving long-term intravenous or tube-feeding treatment that they are more likely to receive high doses of DEHP; and to expedite the development of PVC-free alternatives to those that leach plasticizers.
"Humans are exposed to substantial levels of DEHP through medical devices," says Joel Tickner, the primary author of the Lowell Report. "Given this exposure, along with other health and environmental concerns of PVC," he says, "it’s important to investigate alternative materials for medical purposes."
The Lowell Report precedes two other reviews of the use of DEHP in medical devices scheduled for later this year. The organizations conducting these reviews will be the American Council on Science and Health and the FDA.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content. TESTING
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content