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Warning On DEHP
BETTE HILEMAN
A Health Canada report posted on Jan. 24 warns that medical devices containing di-(2-ethylhexyl) phthalate (DEHP) should not be used in the treatment of infants, young boys, pregnant women, and nursing mothers. DEHP is used as a plasticizer in polyvinyl chloride medical devices such as tubes and intravenous bags used to administer fluids, drugs, or blood.
Although no data confirm the toxicity of DEHP in humans, it causes reproductive and developmental problems in offspring when administered to pregnant rodents, the report says. And the mechanism by which these problems occur in rodents appears relevant to humans, the report explains.
Over the past few years, FDA and the National Toxicology Program have expressed concern about DEHP in medical devices, but the Health Canada report contains the strongest warning to date.
The report, compiled by an expert scientific panel, recommends that tubing and storage bags used for delivery of lipophilic drugs not contain DEHP. It also recommends use of alternative products when treating infants undergoing artificial heart and lung bypass procedures and when feeding infants through stomach tubes.
DEHP-free medical devices "should be introduced as quickly as possible to protect" the fetus, newborns, infants, and young children, the report concludes. Health Canada will issue recommendations on DEHP this summer. The final report can be found at http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/whatsnew.html.
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