May 12 2008 UPDATE – Dozens of Pittsburgh, Pennsylvania patients have been contacting their physicians and pharmacists following the recall of the heart medication Digitek. Manufacturer Actavis Totowa LLC announced the recall after learning that some Digitek tablets were sold in dangerous doses, presenting a health risk to patients.
Dr. Srinivas Murali, director of the McGinnis Cardiovascular Institute at Allegheny General Hospital, said that although the drug is a common heart therapy medicine, it has dangerous side effects that are directly related to its dosage. An overdose of Digitek, or digoxin, may result in nausea, vomiting, a slowed or irregular heart beat, decreased appetite, dizziness, and low blood pressure.
Pittsburgh-area Allegheny General Hospital has received 50 to 100 phone calls from patients with Digitek prescriptions who are concerned about the possibility of bad reactions to the drug. The U.S. Food and Drug Administration has received "several" reports of illnesses and injuries from those who have taken Digitek.
April 2008 ORIGINAL ALERT – Actavis Totowa LLC, a manufacturing division of the pharmaceutical company Actavis Group, has announced a nationwide recall of all strengths of Digitek tablets (digoxin tablets) for oral use. The drug may contain twice the amount of active ingredient allowed, posing a health risk to consumers.
The medication is distributed by Pittsburgh, Pennsylvania-based Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Digitek is used to treat heart failure and abnormal heart rhythms. Double strength tablets of the drug pose a risk of digitalis toxicity in patients with renal failure. Symptoms of digitalis toxicity are nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. In some cases, digitalis toxicity can be fatal.
Several reports of illnesses and injuries have been received. Actavis manufactures Digitek for Mylan and the medication is distributed by Mylan and UDL under the Bertek and UDL labels.