Actavis Totowa a New Jersey based company, earlier in the year started a nationwide recall of all strengths of the Digitek pills, which are distributed by Mylan Pharmaceuticals Inc. and UDL Laboratories Inc.
The maker of the heart drug Digitek faces several federal lawsuits in New Jersey, including one where a patient died, alleging the drug was dangerous and defective.
The lawsuits were filed in U.S. District Court in Newark against Actavis Totowa LLL of Morristown, N.J., and its Iceland-based parent, Actavis Group, a generic pharmaceutical company.
Actavis said that some tablets may have been twice the usual thickness and so would contain twice the active ingredient, digitalis, increasing the risk of toxicity with symptoms from nausea and dizziness to low blood pressure and cardiac instability.
Medical Analysis: Digitalis which is derived from the foxglove plant, has a very narrow therapeutic window and small increases in dosage can lead to toxicity particularly in patients with kidney dysfunction.