B. Braun Medical next to recall Heparin

B. Braun Medical has recalled 23 lots of Heparin amid scare of contaminant present in the blood thinner. The step was taken when its supplier notified of the presence of over-sulphated chondroitin sulfate in an ingredient.

Irvine, California based B. Braun Medical's has joined Baxter in the recall of the contaminated heparin. Both manufacturers have the same supplier, Wisconsin-based Scientific Protein Laboratories, which owns a Chinese factory, Changzhou SPL and provides an ingredient used in the heparin production.

"At this time, Braun Medical Inc. has not received any adverse event reports," Rick Williamson, a company spokesman said.

Heparin is derived from mucus that coats pig intestines and is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.

The most common reactions that are developed are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure.

In January, Baxter had voluntarily recalled nine lots of its heparin sodium injection in 1,000-unit vials, after reports of adverse reactions.

Baxter's heparin had been linked to serious allergic reactions and FDA had received 785 reports of infections by Baxter produced heparin, including 19 deaths. Braun's heparin is sold to hospitals as a pre-mixed solution in intravenous drip bags.

Wisconsin-based Scientific Protein Laboratories had disclosed that an ingredient provided by the company contained over-sulphated chondroitin sulfate. The compound Chondroitin Sulphate occurs naturally and is used as a dietary supplement to treat joint pain. But the over-sulphated version of the compound is not that common.

“The contaminant, a modified version of a nutritional supplement derived from animal cartilage, isn't approved in the U.S. for medical use,” said Janet Woodcock, head of the U.S. FDA drug division.

Federal officials are investigating how the contaminant got into the drug. There have been similar recalls of Chinese-sourced heparin in Germany and Japan.

The FDA hopes to place eight staff members in China to ensure food and drug safety. The FDA never inspected the heparin plant in China because of a mix-up with a supplier that has a similar name.

The main concern behind such large recalls is that there might be a shortage of the drug. The drug is very essential in surgeries and is used in large-dose injections just prior to surgery

FDA officials however said that recall would still allow for an adequate supply of heparin.