More Jefferson County suits filed over Digitek dosage

-The South East Texas Record

07/23/2009 - Actavis, UDL Laboratories and Mylan Pharmaceuticals are being sued by at least three different plaintiffs who claim they or their deceased relative took a prescription drug for heart problems that contained twice the approved level of its active ingredient.

Plaintiffs in the three suits - Virginia Robinson, Helen Keltz and A.B. Belrose, on behalf of decedent Glenda Belrose - claim they or the deceased were taking Digitek. The drug is normally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, before it was recalled on April 25, 2008.

The complaints claim that little information has been released about the recalled Digitek, which reportedly contained twice the approved level of an active ingredient that can cause digitalis toxicity.

Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia, according to a warning the FDA issued about the drug.

Class I recalls are only instituted when there exists a reasonable probability that the drug will cause serious injury or death, the complaints say.

"Digitek has a narrow therapeutic index, and thus, has a limited margin between effectiveness and toxicity," the suits state. "Digitek manufactured and produced with an amount of digoxin in excess of the labeled dose is not approved for sale or distribution in the United States and can cause a variety of serious health problems, up to and including death."

On Aug. 15, 2006, the FDA sent a warning letter to the defendants about their violations of adverse medical event reporting obligations by marketing drugs without clearance and by causing at least 26 adverse drug experiences by not submitting safety reports, the plaintiffs say.

The plaintiffs say they have experienced pain and suffering, mental anguish, physical impairment and a loss of earning capacity, plus incurred medical expenses because of their ingestion of the drug.

They are asking the court to issue an order authorizing an international service company to serve Actavis Group.

In addition to the Jefferson County lawsuit, Mylan and Actavis are facing multiple lawsuits in St. Clair County District Court in Illinois in which plaintiffs are complaining of the same overdose problems with the drug Digitek.

The Jefferson County plaintiffs are seeking actual and exemplary damages, plus pre- and post-judgment interest, costs and other relief to which they may be entitled.

Jefferson County District Court case numbers:E184-522 ,B184-523, B184-524.

If you are currently taking Digitek (digoxin) and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Digitek (digoxin) , without first consulting with your doctor. If you or a loved one have suffered due to DIgitek (digoxin) side effects contact the Digitek Attorneys of Ennis & Ennis, P.A. by filling out our free Digitek case evaluation form or by calling the toll-free number listed below.