FDA tells doctors new heparin formula less potent
The Food and Drug Administration is “alerting doctors that a widely-used blood thinner has been reformulated to improve its safety, though the change could open the door to dosing errors” (AP for FindLaw, 10/1). The FDA is alerting doctors about the change in potency so they will be aware that patients may need higher dosages to achieve the same effect.
The drug, Heparin, will be ten percent less potent than the original drug. The change was designed to make it easier to spot impurities in the drug, which was linked last year to hundreds of life-threatening allergic reactions and deaths. As a result of the problems with contamination, “the drug was recalled by Baxter International and the U.S. blocked imports from a Chinese company that supplied the key ingredient.”
As a Chicago lawyer who has seen too many disastrous drug cases, I am pleased to see the FDA’s actions in communicating to doctors the changes in a drug. Changes in drug composition can be especially dangerous after the drug has been on the market and doctors are accustomed to prescribing the drug. Under such circumstances, it is extremely important that doctors be made aware of changes so they can prescribe accordingly.
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