MONDAY, Sept. 17, 2001 (HealthDayNews) -- The Food and Drug Administration (FDA) says a controversial chemical used in medical tubing and blood bags may harm sexual development in male infants.
The federal agency's safety assessment, released earlier this month, is the latest development in what's become a hotly debated medical issue involving DEHP, a chemical that can leach from plastic into liquids. Animal studies have found large doses of DEHP can harm the development of testicles and production of sperm in young male animals.
The FDA plans to alert doctors who treat newborns in intensive care units to the risks of DEHP. In some cases, male infants can be exposed to up to 20 times the tolerable dose of the chemical through feeding and intravenous tubes.
"The advice given to physicians is to be aware of this heightened risk for a specific population," says Donald Marlowe, director of the FDA's Office of Science and Technology. "We have done a risk assessment. We have put out the best information available, and what populations are affected. Now, doctors need to make decisions."
One group that has been warning the public for some time about the dangers of DEHP applauds the FDA's action.
"We support the FDA safety assessment and believe that the assessment is scientifically sound and based on what we're learning about DEHP as a sexual developmental toxin. This is a very important decision for providers of health care," says Charlotte Brody, spokeswoman for Health Care Without Harm, an umbrella group representing more than 170 hospitals, advocacy organizations and medical associations.
Brody says there are alternatives to DEHP, including other plastics that don't need the softening that DEHP provides. She cites Baxter International Inc., a leading manufacturer of intravenous bags, which agreed this spring to phase out use of polyvinyl chloride (PVC) tubing that contains DEHP.
"We're just coming to terms with this problem, and it takes some time. Now they [FDA officials] have to figure out what to do about their conclusions," Brody says.
She says the agency could consider labeling products with DEHP, training sessions for health-care professionals and starting a dialogue with the manufacturers of medical tubing.
But Marlowe says the FDA does not plan go beyond alerting the medical community to their findings. The agency already has rejected a petition from Health Care Without Harm to label any medical products that contain DEHP.
"We will always be willing to go further" if new evidence warrants it, Marlowe says.
DEHP has been a hot topic recently. A panel of medical experts headed by former U.S. Surgeon General C. Everett Koop concluded this summer that plastics containing DEHP are not harmful. Not surprisingly, the report had its critics.
Jeff Stier, a spokesman for American Council on Science and Health, which brought the panel together, says this latest FDA finding doesn't make sense.
Since only animal studies have shown any dangers from DEHP, Stier says issuing a safety assessment isn't sound science.
"The evidence doesn't support removing products from the market. What is the expected benefit of this change?" he says. "Perhaps it's just another application of the precautionary principle. I guess I'm wondering, why now? We have no evidence that there's any harm to humans."
But Marlowe says toxicology studies, and the FDA safety assessments and warnings that often follow, are rarely done on humans. Risk assessments almost always are based on animal research, and the more species that show damage from exposure, the more likely the FDA will act.
If Health Care Without Harm had its way, even more would be done to protect male infants against DEHP exposure.
"Infertility is a problem in our society. If we can do something prudent and cautious to protect baby boys so that when they grow up, they'll be able to have children when they're ready, we should do that. We should be about that," she says. "The question is, what happens next? How do we go about moving wisely and cautiously away from products that have DEHP?"
What To Do
For more on the potential hazards of medical equipment containing DEHP,
visit Health Care Without Harm. For the other side, try the Vinyl Institute.
To read Baxter International's statement, click here.
