New blood-thinner heparin has 10 percent reduced potency

FDAU. S. health officials have warned that new regulations employed to improve safety standards of blood-thinner heparin will reduce its potency by 10 percent. Contaminated heparin killed 200 people. The last year recall of the heparin vials by Deerfield-based Baxter International Inc. due to severe allergic reactions lead to setting of these new manufacturing standard.

Investigation of case of contaminated heparin revealed that suppliers from China intentionally added animal-like foreign substance known as oversulfated chondroitin sulfate in the drug. The new standards will help manufacturers to find such impurities during the quality-control process. Sulfated chondroitin sulfate is produced from the dietary supplement chondroitin.

Dr. John Jenkins, director of the FDA's Office of New Drugs said that although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug.

FDA will soon conduct tests to find clinical impact of the reduced potency of heparin. Meanwhile the doctors have been warned to keep the reduced potency of drug in mind while prescribing dose of drug.