More of supplier's blood thinner recalled

WASHINGTON -- Another manufacturer of the blood thinner heparin initiated a nationwide recall Friday because some products may contain a potentially dangerous contaminant.

The contaminated heparin is from a different manufacturer other than Deerfield-based Baxter International Inc., whose blood thinner has been associated with 19 deaths and hundreds of allergic reactions.

In the recall announced Friday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with their product, company officials said in a press release.

The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally. Federal officials are investigating how the contaminant got into the drug.

SPL is also a Baxter supplier.

Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. SPL owns a Chinese factory -- Changzhou SPL -- and buys additional raw heparin from other Chinese suppliers.

FDA officials said that recall would still allow for an adequate supply of heparin. The heparin that Baxter recalled primarily is used in large-dose injections just prior to surgery. While the heparin from B. Braun Medical Inc., is a pre-mix solution given intravenously, officials said.

In an unrelated matter Friday, it was learned FDA staff have recommended updating the prescribing instructions for a Baxter anesthesia drug after three reports of cardiac arrest in children.

In documents released Friday, the FDA said it was "possible" the cases were associated with the Baxter drug, Suprane. But they also said each of the patients was being treated with other drugs that may cause cardiac arrest.

The label for Suprane, known generically as desflurane, already carries warnings about other cardiac problems including heart attacks, irregular heart beats and unstable blood pressure.

"The contributory role of desflurane could not be excluded" in the three reports of cardiac arrest in children, FDA staff wrote in a summary prepared for an outside advisory panel.

A Baxter spokeswoman had no immediate comment.