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Problems with Baxter's heparin were first noticed in late 2007 when four children undergoing dialysis had severe allergic reactions minutes after being injected with the drug. The FDA then allowed Baxter Healthcare to deliver the heparin blood thinner that it was in the midst of shipping for fear that a total recall would lead to a shortage of the drug. The FDA cautioned doctors to use as little as possible and to administer it very slowly.
The FDA also suggested that doctors give steroids or antihistamines with the Baxter heparin to help prevent allergic reactions. This leaves a big onus of responsibility on healthcare providers.
U.S. regulators advised doctors to consider alternatives to Baxter’s heparin as shortages are expected. While alternatives exist, doctors warned there could be serious consequences if heparin becomes scarce.
Healthcare facilities and physicians will have to decide immediately what they do with the heparin on hand and they’ll have to start looking for heparin for the long term.
Doctors think they would face difficult choices if heparin supplies ran low since it’s essential to dialysis treatment. Without heparin, many more patients would likely experience significant blood loss, worsening their chronic anemia. Trying to operate without heparin would be a scary proposition for the dialysis industry.
The advisory from the FDA (dated Feb. 11, 2008) advises health care practitioners to switch suppliers and limit use of drug until problem identified.
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