News for January, 2009

Alabama man dies after consuming Digitek

Nicholas Chandler, a 23-year-old resident of Alabama, died after consuming Digitek (Digozin) on Jan. 9, 2009. His doctor prescribed Digitek (Digozin) in order to correct his heart condition that could not be corrected by other medications. Chandler suffered toxicity after taking the medication.

Chandler’s wife Barbara Chandler deems the defendants negligent because was distributed to the public with twice the amount of the active ingredient, according to the West Virginia Record.

The paper reports, “ (Digozin) has a narrow therapeutic index and has a limited margin between effectiveness and toxicity. Chandler, as administratix of the estate is seeking judgment, jointly and severly, (sic.) from all defendants, pre and post judgment interest and costs.”

FDA awaits Actavis permanent injunction

The drug company Actavis, producer of the heart drug Digitek, agreed to close several plants in New Jersey and will not resume operations at these plants until U.S. standards for testing and manufacturing have been met by the . According to Pharma Tech Live, the has filed a consent degree, banning from distributing drugs in Totowa and Little Falls, N.J. The agreement also gives the the right to close the plants if violations persist and to fine the company $15,000 a day afterward.

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Actavis N.J. plant agrees with FDA

Actavis Inc. has made an agreement with the not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.

According to the Philadelphia Inquirer, the agreement says cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” must improve its labs, facilities, and equipment.

has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that is an unsafe and flawed drug.

would not comment if the agreement had influenced the Digitek lawsuits or not.