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Digitek Recall Raises Concerns over Actavis Manufacturing

Jun 4, 2008 | Parker Waichman LLP

A Digitek recall in April has raised questions about the way that the drug - a generic form of digoxin was manufactured.  According to a Digitek class action lawsuit filed in US District Court in New Jersey, a US plant that made some of the defective Digitek tablets was the subject of a Food & Drug Administration (FDA) warning letter in 2006. 

In April 2008, Actavis Towtowa recalled Digitek tablets because some to the medication contained twice the active ingredient normally found in Digitek.  According to the FDA, the Digitek defect could cause serious and even fatal reactions in users. The recall involved  all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use.  Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Actavis manufactures the products for Mylan Laboratories, which are distributed by Mylan and UDL under the Bertek and UDL labels.

 The 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.  Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia.   Bradycardia is a slower than normal heartbeat rate. 

 According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek.  Actavis said it had 11 such reports.  But because not all adverse reactions are reported to the FDA or manufacturers, the true number could be much higher.

In May 2008, A Digitek class action lawsuit was filed in US District Court in New Jersey against  Actavis,  Mylan and UDL Laboratories.  At least one of the plaintiffs in the Digitek class action lawsuit alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug. 

The Digitek class action lawsuit alleges that  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 Little Falls, N.J.  According to the complaint, some of the faulty Digitek came out of that plant. The Digitek lawsuit also claims that 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.

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