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An FDA (U.S. Food and Drug Administration) letter to Digitek’s manufacturer, Actavis Totowa LLC, blasted the company for safety and reporting violations – behavior that may have led to the company recalling the heart drug due to specific lots being shipped that may have contained double the normal potency which could lead to serious injury or death.

FDA letter

The FDA, via the U.S. Department of Health & Human Services, sent a letter to Actavis following an inspection of their New Jersey plant from January 10th to February 8th 2006. The letter, dated August 15th 2006, blasts the company for the following safety and reporting violations:

• Six potentially serious and unexpected adverse drug events dating back to 1999 for products such as Digoxin [Digitek] … that were not reported to the FDA.
• Two cases where the patients’ adverse experiences had not [been] resolved when your firm received the initial reports, and in one case where only minimal case information concerning a fatal adverse event had been initially reported to your firm, there were no follow-up investigations.
• Data received from … spontaneous reports or clinical trials were not reviewed for seriousness and expectedness.
• The inspection found that your firm is not following procedures that were established for filing periodic safety reports. This failure to submit periodic safety reports has resulted in at least 26 ADEs [Adverse Drug Experiences] which were never reported to the FDA.
• Your firm lacks procedures regarding follow-up investigations, adequate completion of the MedWatch form, maintenance of records to assure timely submission of … reports and evaluation of adverse event data for serious outcome of event expectedness.

To view the letter, go to: www.usrecallnews.com/FDA-Letter-Digitek.pdf

Digitek recall

Despite the FDA’s warnings, Actavis continues to have safety issues. The company recently recalled Digitek, a drug used to treat heart failure and abnormal heart rhythms. Some lots of the drug contained double strength tablets which pose a risk of digitalis toxicity in patients with renal failure.

Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia (which is a resting heart rate of less than 60 beats per minute) and even death. At this time, several reports of illnesses and injuries have been received.

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