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DIGITEK DOUBLE DOSE
On April 25, 2008, Actavis Totowa recalled all lots of its heart medicine Digitek (generic name digoxin) due to a manufacturing defect: tablets were found to have double the appropriate thickness and potentially twice the amount of the active ingredient. Digitek is commonly used to adjust irregular heartbeats and is the country's leading treatment of congestive heart failure, both in humans and pets. Digitek is widely sold through mail-order medication businesses and large retailers such as Wal-Mart, Target and Costco.
Actavis reported several patients becoming ill after taking "double doses" of the drug. However, it is believed that many more patients have not yet reported their symptoms, possibly because they were not told of the recall. In some cases doctors are sending letters to their patients but Actavis has not placed advertisements in newspapers or on television, which would be the most effective method of notification. Instead, pharmacists have been notifying their customers of the recall, telling them to return Digitek immediately for an alternative medication.
The Food & Drug Administration (FDA) classified the Digitek recall as a "Class I", which means the defective Digitek tablets could cause serious health problems or even death. The drug company said the double-strength tablets pose a risk of toxicity in patients with renal failure.
Since the 18th century, digitalis—a chemical derived from the foxglove plant—has been used as a heart medicine. Digitek and digitalis derivatives increase the amount of calcium in the heart's cells by strengthening the force of the heartbeat. Digitalis medicines are also used to control irregular heart rhythms (called arrhythmias) by slowing the signals that start in the sinoatrial (SA) node.
Just one double-strength Digitek tablet can potentially cause digitalis toxicity, particularly in patients suffering renal failure. Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia—a slower than normal heartbeat rate.
Other side effects include vision changes such as halos or light rings around objects, seeing lights and bright colors, changes in color perception, blind spots in vision, and blurred vision. Digitalis toxicity can also result in decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. It can also cause death.
Class action lawsuits have now been filed against the Icelandic generic drug-maker Actavis, along with distributers Mylan Pharmaceuticals Inc. and UDL Laboratories, Inc. One suit claims that in August 2006 the FDA issued a warning letter to Actavis because it failed to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. Allegedly, lots of recalled Digitek came from the same plant. The suit further claims that an FDA inspection before August found six potentially serious and unexpected adverse drug events going back as far back as 1999 (when it was approved by the FDA) that included Digitek, but weren’t reported to the agency.
In early May, a consumer fraud class action suit filed in Kansas City claims negligence, liability, breach of warranty, fraudulent misrepresentation, fraudulent concealment and violations of consumer protection statutes. It also seeks to bar Mylan Pharmaceuticals and UDL Laboratories from distributing the drug.
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