Digitek Deaths May Have Topped 600Dec 24, 2008 | Parker Waichman LLP
A new report says that Digitek tablets have been named a suspect in more than 600 deaths. Digitek tablets were recalled in April by Actavis Totowa because of a manufacturing defect. Actavis said at the time that some Digitek tablets might have been oversized, and could expose patients to a dangerously high level of the drug's active ingredient.
The Food & Drug Administration (FDA) deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.
A new report by the Center for Public Integrity has found that the number of fatalities associated with Digitek spiked around the time of the recall. According to the report, there were 667 deaths reported to the FDA Adverse Events Reporting System that involved Digitek between April 1 and June 30. The group also found that FDA had received just one reported death attributed to Digitek in the previous three-month reporting period. The Center says the FDA has confirmed the findings of its analysis.
The Center's report faults the FDA for taking too long to act on problems at the New Jersey Actavis plant where Digitek was made. As we've previously reported, the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in New Jersey. Another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
The Digitek recall was issued in April 2008, and then in August, Actavis issued another recall of all generic drugs made at the New Jersey facility. That recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices. After the August recall, Actavis finally closed the New Jersey plant to institute “remediation” efforts.
The problems at Actavis prompted the House of Representatives Energy and Commerce Committee to begin an investigation into the FDA's oversight of the company's drug manufacturing operations. In October, the Committee asked the FDA to provide it with all information pertaining to all FDA-regulated products that Actavis has received approval to sell since January 2003, as well as all drugs Actavis imports to the U.S. regardless of approval date. The Committee wanted to know if the FDA was deceived by Actavis when it inspected the company’s facilities, or if the agency failed to do adequate inspections.
In November, the US Justice Department filed suit against Actavis, seeking to permanently shut down its New Jersey operation. The lawsuit seeks a permanent injunction to bar Actavis Totowa and Actavis Inc, as well as two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.