Extent of Digitek Problems remains unclear

It has been over three weeks since a nationwide Digitek recall was issued after it was discovered that some tablets could contain twice the appropriate strength. However, very little information has been released about the extent of the Digitek problems and exactly how long double strength tablets have been sold.

Digitek is a generic form of digoxin, which is prescribed for treatment of heart failure and cardiac arrhythmias. It contains digitalis, which can cause a severe illness known as digitalis toxicity when it accumulates in the body. On April 25, 2008, Actavis Totowa issued a recall for Digitek after it was discovered that some tablets that left their manufacturing process twice as thick as they are suppose to be, containing double the appropriate amount of active pharmaceutical ingredient.

The Digitek recall notice indicated that Actavis had received “several reports of illnesses and injuries” consistent with digitalis toxicity. In a May 2, 2008 Newsday article about the Digitek problems, an Actavis spokesperson indicated that the company and the FDA had received complaints of side effects since 2006. However, no estimates or indications have been released about how many of these defective tablets were sold, or how the manufacturer allowed this to happen.

PRIOR MANUFACTURING PROBLEMS AT DIGITEK PLANT

The 2008 Digitek recall was not the first sign of problems at the New Jersey plant where the pills were made. In February 2007, the FDA sent a warning letter to Actavis Totowa after an inspection of the facility found that certain products made at the plant were “adulterated’. The FDA indicated that Actavis failed to establish the identity, strength, quality and purity of drug products they were making at the facility and inspectors noted several violations of good manufacturing processes. Some of the findings outlined in the warning letter included:

• In May 2006, a batch of hydrochloprothiazide tablets which failed to achieve the target hardness passed initial quality control.
• The company’s cleaning processes were found to be inadequate, without assurance that there was proper cleaning between the manufacture of different drugs.
• At least one machine was found to be strapped with duct tape to prevent powder from escaping.

>>LINK: 2007 FDA Warning Letter to Actavis

According to a May 6, 2008 report from inPharmaTechnologist.com, an Actavis spokesperson denied that the issues identified in the 2007 warning letter were related to the 2008 recall. They indicated that all of the issues outlined were resolved to the FDA’s satisfaction. However, the prior violations certainly indicate that over the past few years production problems have existed at the plant.

Actavis was also involved in another recent recall involving manufacturing problems with their generic fentanyl patches. In March 2008, Actavis issued a fentanyl patch recall after it was discovered that some of their powerful painkilling patches contained “fold-over” defects which could allow the fentanyl gel to leak out and come into direct contact with the skin. It is unclear whether these defective pain patches were made at the same plant as the Digitex.

DIGITEK LAWYERS

The lawyers at Saiontz & Kirk, P.A. are investigating potential Digitek lawsuits for individuals who have suffered an injury consistent with digitalis toxicity. Symptoms of the illness that could be caused by the Digitek problems include:

• Nausea, Vomiting, Diarrhea, Dizziness, Confusion or Loss of Appetite
• Low Blood Pressure
• Cardiac Instability, Irregular Pulse, Heart Palpitations
• Badycardia (slower heartbeat)
• Vision Changes (halos, changes in color, blind spots, blurred vision)
• Changes in Urination
• Difficulty Breathing

If you, a friend or family member have experienced problems after taking Digitek which resulted in medical treatment, request a free consultation and claim evaluation.