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

The manufacturers have recalled Digitek. Actavis Totowa (formerly Amide Pharmaceutical, Inc.), post findings that some of the tablets contained twice the approved level of the active ingredient used in the medicine immediately recalled its product from the shelves. The class I recall was initiated in April 2008 when the FDA started receiving reports of severe illnesses amongst patients who were administered a drub called Digitek. These tablets were a double-strength tablets that caused toxicity in the patients suffering from renal failure. These tablets caused a condition called Digitalis, which accumulated in the body instead of being passed out through urine. This dysfunction disrupts the proper functioning of the kidney and further aggravates the toxicity leading to problems, such as, nausea, vomiting, diarrhea, dizziness, low blood pressure, cardiac instability and bradycardia.

Digitek is another form of digitalis; it comes from a chemical derived from the ‘foxglove plant’. This has been used as a heart medicine since the 18th Century. The FDA (Food & Drug Administration) sited the recall as a Class I recall as the defective Digitek drug could cause potentially serious health problems or death. Few other symptoms of Digitalis toxicity include nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, weakness, confusion, hallucinations, and heart palpitations. Some patients suffering from Digitalis or Digoxin toxicity may suffer from yellow vision in which objects and light appear yellow in color and blurred. Digoxin / Digitalis toxicity may also result in low heart rate called bradycardia and in increased or rapid heartbeat called tachycardia. Digitalis / Digoxin/ Digitoxin toxicity may cause severe weight loss due to the reduced appetite.

Despite reports of health issues in the consumers of Digitek, Actavis has did not take appropriate or necessary steps to provide the FDA with 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 being negligent, irresponsible and 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.

The report further mentions that the out-of-specification (OSS) test results were not documented properly and the product was released based on retesting without providing any valid reasons for ignoring the initial OSS results.

Actavis responded to the FDA and promised 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 is compliant with the good manufacturing practices.
As part of a Class I recall, all pharmacies are doing a double check on the list of their patients who have been prescribed this medicine and they are even calling up the patients informing them about the faulty medicines.

For more information about the Digitek Recall see Digitek Recall.

The manufacturers have recalled Digitek. Actavis Totowa (formerly Amide Pharmaceutical, Inc.), post findings that some of the tablets contained twice the approved level of the active ingredient used in the medicine immediately recalled its product from the shelves. The class I recall was initiated in April 2008 when the FDA started receiving reports of severe illnesses amongst patients who were administered a drub called Digitek. These tablets were a double-strength tablets that caused toxicity in the patients suffering from renal failure. These tablets caused a condition called Digitalis, which accumulated in the body instead of being passed out through urine. This dysfunction disrupts the proper functioning of the kidney and further aggravates the toxicity leading to problems, such as, nausea, vomiting, diarrhea, dizziness, low blood pressure, cardiac instability and bradycardia.
Digitek is another form of digitalis; it comes from a chemical derived from the ‘foxglove plant’. This has been used as a heart medicine since the 18th Century. The FDA (Food & Drug Administration) sited the recall as a Class I recall as the defective Digitek drug could cause potentially serious health problems or death. Few other symptoms of Digitalis toxicity include nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, weakness, confusion, hallucinations, and heart palpitations. Some patients suffering from Digitalis or Digoxin toxicity may suffer from yellow vision in which objects and light appear yellow in color and blurred. Digoxin / Digitalis toxicity may also result in low heart rate called bradycardia and in increased or rapid heartbeat called tachycardia. Digitalis / Digoxin/ Digitoxin toxicity may cause severe weight loss due to the reduced appetite.
Despite reports of health issues in the consumers of Digitek, Actavis has did not take appropriate or necessary steps to provide the FDA with 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 being negligent, irresponsible and 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.
The report further mentions that the out-of-specification (OSS) test results were not documented properly and the product was released based on retesting without providing any valid reasons for ignoring the initial OSS results.

Actavis responded to the FDA and promised 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 is compliant with the good manufacturing practices.
As part of a Class I recall, all pharmacies are doing a double check on the list of their patients who have been prescribed this medicine and they are even calling up the patients informing them about the faulty medicines.

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.