FDA WARNS OF HEPARIN PRODUCT MIX-UP AFTER INFANT DEATHS

Baxter and the FDA have alerted healthcare providers to three infant deaths due to mix-ups of two of the company's heparin products, the agency said.

The three infants died after receiving much higher than intended dosages of the anticoagulant heparin when two products were mistaken for each other, according to an FDA MedWatch alert. Premature infants are given a diluted form of heparin, known as hep-lock, to keep their intravenous lines open. The fatalities occurred when infants received heparin sodium injection, which has 10,000 units per mL, instead of hep-lock u/p, which contains 10 units per mL.

Both products are currently marketed in clear 1-mL vials with similar blue labels, the letter said. The higher-dose heparin product has a tan cap and uses a darker shade of blue for the text, while hep-lock has a bright green cap and light blue text, according to pictures included in the letter.

A lawyer representing the families of two premature infants who died of accidental heparin overdoses at Methodist Hospital in Indianapolis called for a change in labeling to help differentiate between the products used in adults and those used in infants.

Nathaniel Lee of Lee, Cossell, Kuehn said he knew of at least six cases where infants were given the wrong doses of heparin.