The Food and Drug Administration has issued a Class I recall of the drug Digitek® after reports of serious adverse reactions and digitalis toxicity in some users. Digitek® is used to treat congestive heart failure and atrial fibrillation/atrial flutter, which are types of fast heartbeats.
Digitek® was subject to a nationwide recall on April 25, 2008. The recall applied to all oral strength tablets of Digitek® due to Digitek® tablets containing twice the approved level of active ingredient, which led to heart patients getting huge doses of a potentially lethal drug (1) and serious drug injuries. Class I recalls only occur when there is a reasonable probability that use or exposure of the product will cause drug injury or death.
As the result of apparent manufacturing mistakes, these double-strength tablets were exposing patients to a risk of digitalis toxicity. Digitalis toxicity can cause a number of drug injuries, including severe cardiac impairment and death and results when someone is exposed to an overdose of the active ingredient in Digitek® and other, similar drugs (1).
Actavis Totowa LLC (formerly known as Amide Pharmaceutical Inc.) makes Digitek®. Mylan Pharmaceuticals, Inc., distributes Digitek® under the “Bertek” and “UDL” labels.
If you or someone you know took Digitek® and suffered serious cardiac problems, we want to help. Our drug injury lawyers are currently investigating these cases and seeking compensation for the victims of Digitek® overdoses. Call us or fill out a free online consultation form so you can tell us what happened.
Whether you need a defective medical device lawyer or an environmental danger attorney, we will protect your rights. Call Ferrer, Poirot & Wansbrough today.
Sources:
1) “Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution” on 4/25/08. Accessed 4/25/08 via www.fda.gov/oc/po/firmrecalls/actavis04_08.html.
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