New USP standards to decrease heparin potency, FDA warns

ROCKVILLE, Md. New standards for heparin will reduce the potency of the blood thinner, the Food and Drug Administration has warned.

The FDA alerted healthcare professionals Thursday that new manufacturing standards for heparin adopted by the United States Pharmacopeia to ensure its quality and guard against contamination would decrease the potency of the drug, requiring adjustments to achieve the desired anticoagulant effects.

Supplies of heparin conforming to the new standards will begin shipping Oct. 8.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that healthcare professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research.