Digitek
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Digitek
Digitek is the brand name for a heart medication known generically as digoxin. It was originally derived from the foxglove plant and has been used for medical purposes since the 18th century. Today, Digitek is a widely prescribed medication for treatment of irregular heart beat and for congestive heart failure. The drug is manufactured by a unit of Actavis Totowa and is distributed by Mylan Pharmaceuticals Inc., under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label. Both labels are affiliates of Mylan.
Generally, Digitek improves the strength and efficiency of the heart, which leads to better circulation of blood and reduction of the uncomfortable swelling that is common in people with congestive heart failure. It is often prescribed along with a diuretic (to help relieve swelling) and a drug called an ACE inhibitor (to further improve circulation). Until this year, Digitek has been a common treatment for patients exhibiting a variety of heart-related symptoms.
Digoxin can also be poisonous when consumed in excessive amounts. That is why Actavis recalled all Digitek pills currently in circulation on April 28th of 2008, because it had come to light that some of their tablets may have been manufactured containing twice the dosage of digoxin that was reflected on the packaging. Actavis had received several complaints about reactions to Digitek, as had the FDA. Digitek was pulled from the shelves in all dosages and in every region of the country.
There is apparently a fine line between the proper dosage of Digitek – that is, enough to have an impact on congestive heart failure – and an overdose, which can incite serious side effects up to death. Those side effects include nausea, vomiting, blurred vision, an abnormally slow heart rate, palpitations and an irregular pulse. Patients who unwittingly take twice the prescribed dose can be exposed to significant physical trauma.
The Digitek recall was put in the Class I category by the FDA. Class I means that the recall extends all the way to the consumer, who should return the prescription to the pharmacy. Often recalls for medication only reach the pharmacy level and doses that area already in circulation are not included.
In the case of Digitek and the potentially lethal effects of an overdose, the FDA felt that recapturing every dose possible was in order. The recall does not mean that Digitek is not an effective and appropriate medication if taken properly. It is really an indictment of the manufacturing quality control practiced in the Actavis production facility.
Digitek In The News
Federal regulators sue to halt production of Actavis heart drugFederal regulators are seeking a permanent injunction against production of the heart drug Digitek by Actavis at a plant it operates in Little Falls, according to Bloomberg News.The legal action, taken by the Justice Department on behalf of the Food...
Attorneys move to close Actavis NJ facilitiesU.S. Attorneys in New Jersey on Friday filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations. The complaint requests that the court prevent Actavis Inc.,...
Actavis Comments on Filing of DOJ ComplaintMORRISTOWN, N.J.----Actavis, Inc. today said that the Department of Justice, on behalf of the Food and Drug Administration , has filed a complaint seeking a permanent injunction against the business of its Actavis Totowa LLC subsidiary.
Attorneys move to close Actavis NJ facilitiesU.S. Attorneys in New Jersey on Friday filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations.
Actavis Sued by U.S. Regulators to Shut Heart Drug ManufacturerNov. 13 (Bloomberg) -- Actavis Group hf said U.S. regulators sued seeking a permanent injunction against its subsidiary that makes the heart drug Digitek.
Lawsuit targets Actavis plantsNEW YORK — U.S. attorneys in New Jersey on Friday filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations.
Mother�s death reason for Becnel to file this suitEditor and Publisher RESERVE – Danny Becnel has handled so many class action lawsuits in his lengthy legal career that he might not even remember many of them.
