A great summation of the Digitek debacle
It has been a rough eight months for the drug maker Actavis, Inc. and its powerful heart drug, Digitek. Following repeated Food and Drug Administration (FDA) criticisms of its manufacturing processes, Actavis Totowa, a subsidiary of Actavis, issued a recall of Digitek on April 25, after discovering that some of the tablets were twice as thick as intended, and thus contained double the dose meant for a patient. Digitek is so potent that even a slight increase in dosage can be toxic or fatal. In August, Actavis closed a plant in Little Falls, New Jersey, that manufactured Digitek, to institute “remediation” efforts; that closure also effectively shut two other Actavis facilities that provide laboratory and packaging services. In October, two members of the House of Representatives launched an inquiry into the FDA’s oversight of Actavis. Then, just last month, the U.S. Justice Department asked a federal judge to permanently enjoin Actavis and Actavis Totowa from manufacturing drugs until the firm could demonstrate compliance with FDA “Good Manufacturing Practice” requirements.
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Any medical student can tell you about the narrow margin of safety with digoxin.” As soon as officials knew that some patients could have been given double-doses of digoxin, he stressed, “the FDA should act to protect the public, unless and until it is substantially shown that there is no danger — rather than taking no action until someone can ‘prove’ that there is danger.”
I’ll have to add this blog to my watch list.
P.S. – Digoxin was the drug that poisoned James Bond in Casino Royale. Perhaps the bad guys worked for Actavis…