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Digitek: Manufacturing Error leads to Recall
The heart medication Digitek was recalled in April 2008, apparently due to a manufacturing error. The FDA classified the Digitek recall a Class I recall, meaning that the defective “double dose” Digitek tables may contain twice the approved level of active ingredient than is appropriate. Countless injuries have been reported and at least one death. However, the FDA and the manufacturer had received 11 complaints about Digitek side effects since 2006.
Digitalis toxicity can cause serious health problems and even death. It may be caused by an acute ingestion of digitalis and it can occur from just one single exposure or chronic overmedication. Renal patients are more at risk because reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.
Symptoms of digitalis toxicity include 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.
Patients suffering digitalis toxicity can also experience vision changes and blurred vision. Other symptoms include decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down.
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. The brand Digitek is made by Icelandic generic drug-maker Actavis Towtowa and is sold by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
A class action lawsuit was filed just a few weeks after the Digitek recall. It claims that the FDA issued a warning to the manufacturer in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. According to the suit, some of the defective Digitek was made in that plant. The lawsuit further claims that the FDA inspected the plant months earlier and found six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek but were not reported to the agency.
To date, several lawsuits have been filed against Actavis Totowa LLC, Mylan Mylan Pharmaceuticals, Mylan Bertek Pharmaceuticals and UDL Laboratories Inc. One lawsuit alleges that a patient died after consuming Digitek and in other suits, patients claim they were injured because the pills they recently consumed contained twice the federally approved level of active ingredient.
Digitek has been the country's leading treatment for congestive heart failure for many years--in humans and in pets. It can be purchased by mail-order, in large retail stores and in pharmacies. Consumers who have taken Digitek between March 2006 and April 2008 have been advised to contact their physicians and return the Digitek to their supplier. Consumers who have become ill from taking double-dose Digitek may also want to seek legal help.
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