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FDA Warns of Chemical in Plastic [Preventing Masculinization]

Mon Jul 15, 4:59 PM ET

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - Sick baby boys may be at highest risk from a chemical used to soften such plastic medical devices as blood bags and IV tubes, the government says in advising hospitals to consider using devices made of different materials to treat them.

The chemical, called DEHP, can leach from the plastic into certain liquids, especially fat-containing ones like blood. Studies of young animals show the chemical can affect testicle development and production of normal sperm.

There's no proof DEHP actually harms humans. But the Food and Drug Administration ( news - web sites) considers the theoretical risk important enough that it's writing health groups to urge they take limit DEHP exposure to the patients at highest risk.

That's mainly newborn boys who need lots of treatments that bring the highest DEHP exposures — such as multiple blood transfusions and IV tube feeding, FDA toxicologist Ron Brown said Monday. Also, an oxygenation procedure called ECMO that basically puts newborns on a heart-lung machine for several days causes high exposure.

Also on the precaution list is dialysis if the patient is a boy undergoing puberty, or a woman pregnant with a male fetus or nursing a baby boy.

Don't curtail treating these patients — they need medical care more than they need to avoid the theoretical DEHP risk, the FDA stressed.

But health workers should consider using alternative medical equipment, such as devices coated with heparin, silicon or other substances to prevent DEHP from leaching, said FDA biologist Laura Alonge.

The amount of chemical absorbed is too small to be of concern for most patients, the FDA concluded in a safety assessment of DEHP last fall. The average IV treatment, even the average blood transfusion, leach very little.

But the FDA said small groups of patients could absorb many times the safe-limit dose suggested by animal studies, and the new letters to health providers mark FDA's long-awaited advice on precautions to take with those people.

"FDA's public health notification falls far short of what is needed to protect patients," said Charlotte Brody of Health Care Without Harm, a group working to reduce the amount of phthalates — the family of chemicals that includes DEHP — in a variety of products, from plastic toys to cosmetics.

The group has lobbied FDA to require medical manufacturers to label if the equipment leaches DEHP.

"How can doctors and nurses protect their patients from phthalates in medical devices when they have no way of knowing which products contain phthalates?" Brody asked.

Some companies already label, and the FDA soon will issue a recommendation — not a requirement — that more do so, Alonge said. The recommendation should be enough because companies will "be at a competitive disadvantage if they don't," she said.

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