Digitek Recall Highlights Shoddy Manufacturing at Actavis Plant

In April 2008, Actavis Totowa recalled all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use due to a manufacturing problem.   The company said the problem may have resulted in Digitik tablets that were double the normal thickness, which would expose users to an unsafe level of the active ingredient in the medication. 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.

The Digitek recall highlighted the deficient manufacturing conditions at Actavis facilities.  One of them, located in New Jersey, was the subject of an FDA warning letter in 2007.  Just months after the Digitek recall, more generic drugs made at that plant were recalled by Actavis.

Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies.  Digitalis medicines strengthen the force of the heartbeat by increasing the amount of calcium in the heart's cells.  The medication also helps control irregular heart rhythms called arrhythmias.

Being exposed to excessive amounts of the active ingredient in Digitek puts patients at risk for digitalis toxicity.  This is especially true of people taking diuretics, which are often prescribed to people with heart problems along with Digitek.  Diuretics can reduce kidney function, which will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.

Digitalis toxicity can occur from a single exposure to defective Digitek tablets, or chronic overmedication. Symptoms of digitalis toxicity include 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. 

Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur.  Patients can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down.  At its most severe, death can result from excessive Digitalis intake. 

When it issued the Digitek recall, Actavis said that it had received 11 reports of illnesses and injuries in patient taking defective Digitek. However, most adverse drug reactions are never reported, so it is likely that this defective drug has injured many more patients.

Shortly after the Digitek recall, victims of the medication filed a class action lawsuit in US District Court in New Jersey against Actavis Group.  In addition to Actavis, the Digitek lawsuit also named Mylan Pharmaceuticals Inc. and UDL Laboratories, which distributed the medication, as defendants.  The plaintiffs in the Digitek lawsuit are seeking compensation for their injuries, as well as the costs of medical monitoring in case they experience future health problems.

At least one of the plaintiffs in the Digitek class action lawsuit allegedly experienced “changed cardiac symptom episodes of nausea, and dizziness� from her Digitek consumption. Another plaintiff allegedly suffered serious personal injuries, including kidney damage, after taking the defective drug.

According to the Digitek class action lawsuit, the FDA issued a warning letter to Actavis following an August 2006 inspection for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an 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. 

In August, Actavis issued another recall of all generic drugs made at the Little Falls, N.J. facility named in the Digitek class action lawsuit.  The recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices. 

The generic drug recall was issued at the retail level only, with Actavis asking pharmacies, hospitals and retailers to return the affected prescription medications. The company said patients should continue to take their medications as directed.  Anyone who wished to have their medicines replaced was advised to consult their healthcare provider.

In February 2007, the FDA issued a warning letter to Actavis Totowa following an inspection of the Little Falls facility completed in August 2006.   Among other problems, FDA inspectors found that the facility’s quality control failed to recognize that some tablets that did not meet in-process specifications.

In the warning letter, the FDA stated that it had reviewed the corrective actions Actavis promised in a letter dated Aug. 29, 2006, and reiterated its concern about the quality of drug products that were released from the facility under the serious lack of controls found during the inspection.  In light of the recent Digitek and generic drug recalls issued by Actavis, it  appears that those problems have not yet been addressed.