January 25, 2009

Criticism Mounts over Digitek Recall

The Institute for Safe Medicine Practices (ISMP) Quarter Watch, a monitoring program that evaluates serious Adverse Event Reports submitted to the FDA, published a critical report on January 15, 2009, illustrating how the April 2008 Digitek (digoxin) recall was mishandled by the FDA and the drug manufacturer Actavis. Although the April 2008 recall was one of the largest Class I drug recalls (approximately 800 million digoxin tablets) affecting more than 1 million heart patients, the FDA allowed Actavis to manage public notification to consumers, doctors, pharmacies, and wholesalers. The data analyzed showed that in January 2006, more than 2,403 adverse event reports had been reported to the FDA and 82% involved injuries that were definitely or possibly associated with the digoxin recall. In addition, facts released have shown that the Actavis plant had widespread manufacturing quality control problems and has since been closed. Neither the company nor the FDA will estimate how many tablets reached consumers or how many tablets have been recovered through the Class I recall.

A new report released in December of 2008 from The Center for Public Integrity (the Center) indicates that FDA records show that between April 1, 2008, and June 30, 2008, Digitek was cited by doctors and consumers as the primary suspect in the deaths of hundreds of patients in the United States. The FDA confirmed reports of 667 deaths reported to the Agency that health care professionals and consumers attributed to Digitek during that same time period.

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