FDA update IDs 'new,' lower-potency heparin

The FDA reports that the blood-thinner heparin sodium made under the new United States Pharmacopeia Monograph has approximately 10 percent less anticoagulant activity than its predecessor. It has issued an update to its heparin drug safety announcement to include a chart identifying the heparin products made to the new standard. The products are from four manufacturers: APP, B. Braun, Hospira and Baxter.

The regulator implies in an update published yesterday that the change may result in some supply chain crossover of new and old products. It advises healthcare professionals to "exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring."

Heparin products based on both the old and new USP standards will likely be available for some time. New heparin became available last October, mingling with the old throughout the supply chain. The FDA issued a public health alert on the potency change the same month.

- here's the FDA update

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