By Catherine Larkin/Bloomberg News
Actavis Group has recalled all lots of the generic heart drug Digitek because they may contain twice as much medicine as they should.
“Several reports of illnesses and injuries have been received” in connection with the tablets, distributed by Mylan Laboratories Inc. under its Bertek and UDL brands, according to a notice posted Monday on the Food and Drug Administration’s Web site. Actavis has received 11 reports of side effects in about a year, though some may be unrelated to this issue, said John LaRocca, the firm’s general counsel.
Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies and is prescribed to treat heart failure and abnormal heart rhythms. Excess dosing in patients with kidney failure may cause nausea, vomiting, dizziness, low blood pressure, slow heartbeat or death, the FDA said. READ MORE
