Link: http://www.digiteklawsuit.org/

Digitek has been voluntarily recalled by its manufacturer, Actavis Totowa (formerly Amide Pharmaceutical, Inc.), after it was suspected that some of the tablets may contain twice the approved level of the active ingredient used in the medicine. The class I recall happened in April 2008 when the FDA had received the reports of severe illnesses amongst patients using Digitek. These double-strength tablets may cause toxicity in the patients suffering from renal failure, which causes digitalis to accumulate in the body instead of being passed out through urine. This disrupts the proper functioning of the kidney and further aggravates the toxicity leading to problems, such as, nausea, vomiting, diarrhoea, dizziness, low blood pressure, cardiac instability and bradycardia.

What is Digitek?
Digitek tablets are prescribed to those patients who suffer serious heart problems, such as, irregular heartbeat, arterial fibrillation, and congestive heart failure. It is available in tablet, capsule, liquid, and injectable forms, however the Digitek recall relates only to the tablets.

How did it happen?
Despite reports of health issues in the consumers of Digitek, Actavis has failed to provide them the information on how long and how many of these double-dosed pills have been in circulation. Many consumers have already filed lawsuit against Actavis for not warning the patients about the risks of consuming Digitek. It has also not been able to explain the reasons for such manufacturing faults. It is interesting to know that Actavis had received warnings from the FDA in 2006 and 2007 as well for violating the ‘Good Manufacturing Practices’ at their New Jersey plant. The letter sent by the FDA to Actavis categorically mentioned that it is difficult to ascertain whether the drugs are being manufactured using the right dosage.
It further mentions that the out-of-specification (OSS) test results were not documented properly and the product was released on the basis of retesting without providing any valid reasons for ignoring the initial OSS results.

In response to the FDA’s warning letter, Actavis responded by promising to take the corrective action. While Actavis seemed sensitive towards the issue, the FDA felt that it should have done more by taking a quick action and bringing in an external agency to ensure that it’s compliant with the good manufacturing practices.

Corrective measures
Pharmacies have been asked to check the list of their patients who have purchased Digitek and to personally inform them about the faulty medicine. The patients, who have consumed the medicine between March 2006 and April 2008, have been asked to consult their physicians and return the medicine to their suppliers.

For more information about the Digitek recall see Digitek Recall.