More Safety Concerns Raised After Class 1 Recall of Dangerous Digitek Pills
Just weeks after the US Food and Drug Administration (FDA) assigned Class 1 status to Actavis Totowa, LLC’s recall of its drug Digitek, possible evidence of faulty manufacturing has come to light. A Class 1 recall is the highest level of product recall, and means that the product involved poses a serious risk of health problems or death.
Recently filed litigation alleges that at least one Actavis manufacturing plant involved in the production of Digitek had run afoul of FDA safety regulations as early as 2006. According to the same lawsuit, several reports of adverse reactions to products containing Digitek were never relayed to the FDA.
Digitek, a drug used to treat abnormal heartbeats or heart failure, was recalled in late April after at least 11 reports of illness or injury in patients taking Digitek. Investigations revealed that many Digitek pills contained double the amount of the active ingredient, digoxin. Digoxin has a narrow therapeutic index; that is, the difference between a safe dose and a toxic, potentially lethal one (known as digitalis toxicity) is very small.
Side effects of the double-dose Digitek include:
- Low blood pressure
- Cardiac instability
- Abnormally slow heart rate
If you or a loved one have been hurt by taking doses of faulty, double-strength Digitek, you deserve justice from the pharmaceutical companies responsible. To learn more about how Actavis Totowa, Mylan Pharmaceuticals, UDL Laboratories, or other companies may be at fault for your injuries, contact a professional from Houston personal injury law firm Williams Hart by calling (888) 220-0640 today.