Digoxin Recall Leads to Congressional Inquiry

By Austin Kirk
Posted October 13, 2008

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Following a series of recalls issued by Actavis this year, including a digoxin recall for all lots of their Digitek heart medication in May 2008, the U.S. House Committee on Energy and Commerce has requested additional information from the FDA about their oversight of the drug maker. This inquiry is part of a continuing investigation by the Committee into the ability of the FDA to protect Americans from dangerous prescription drugs, food products and medical devices.

Rep. John Dingell (D-MI), who is the Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), who is the Chairman of the Oversight and Investigations Subcommittee, sent a letter last week to the FDA Commissioner requesting information about all products the agency approved for Actavis since January 1, 2003.

According to the letter, they are trying to determine whether the FDA was “deceived” regarding the manufacturing practices of the company, or whether the FDA “simply fail(ed) to conduct adequate and timely inspections” of the drug maker’s facilities.

On April 28, 2008, Actavis Totowa, a subsidiary of the generic drug maker Actavis Group, issued a digoxin recall for all lots of their generic drug Digitek, which is used to treat heart failure and abnormal heart rhythms. The recall was issued because the drug maker’s poor manufacturing practices and lack of quality controls allowed thousands of Digitek tablets to be commercially sold that were twice as thick as they were supposed to be.

Double strength Digitek tablets could increase the risk that users suffer digoxin toxicity, which occurs when the medication builds up in the body. This is a particular risk for users with renal failure, and has been linked to serious and life-threatening injuries for users throughout the United States. Symptoms of digoxin toxicity could include nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia or death.

The digoxin recall was not the first sign of problems at the manufacturing plant in New Jersey where these Digitek tablets were produced. In February 2007, the FDA sent a warning letter to Actavis Totowa after an inspection found that certain products made at the plant were “adulterated.” The inspectors identified several quality control failures dating back to 2006, found there were inadequate assurances of cleaning between the manufacture of different drugs and at least one machine was found to be strapped with duct tape to prevent powder from escaping.

Following the digoxin recall, another FDA inspection revealed more violations at the Actavis Totowa plant in New Jersey, leading to another recall for over 65 more generic drugs in August 2008. Although both Actavis and the FDA have indicated that there were no health risks posed by these drugs, the lack of quality controls and the continued violations of good manufacturing practices raised concern for the Congressional committee.

DIGOXIN RECALL LAWSUITS

Since May 2008, the digoxin lawyers at Saiontz & Kirk have been investigating potential Digitek lawsuits for individuals who received the heart medication since 2006 and experienced sudden health problems that may have been caused by digoxin toxicity. If you, a friend or family member have experienced digoxin problems, request a free consultation and claim evaluation.