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RODANAST, P.C.
Attorneys at Law
801 Estelle Drive
Lancaster, PA 17601
Tel: 717.892.3000
Toll Free: 1.888.245.0200
Fax: 717.892.1200
Digitek Recall
Digitek, a prescription-only medication, was recently recalled over the risk of severe and potentially fatal side effects. RODANAST, P.C. represents individuals and families who have been harmed by Digitek treatment.
Digitek Recall April 2008
Derived from digitalis, Digitek can improve the efficiency and strength of the heart, and it is also used to improve blood circulation and reduce swelling of the hands and ankles of patients with cardiac problems. However, the entire line of Digitek oral tablets in the U.S. was voluntarily recalled in April 2008 by the manufacturer, Actavis Totowa, because of an alarming manufacturing mistake, Digitek tablets were manufactured with twice the amount of the active ingredient, digoxin.
The recall was considered a Class I recall, an FDA designation for situations in which there is "a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death." The recalled Digitek is particularly dangerous to individuals with any degree of kidney impairment.
The recalled Digitek was of all strengths/dosages of oral Digitek tablets distributed by two companies, Mylan Pharmaceuticals (labeled "Bertek Digitek") and UDL Laboratories (labeled "UDL Digitek").
FDA Safety Alert
The other forms in which Digitek is made (elixir, intravenous/intramuscular injection, liquid-filled capsules) were not recalled. However, a few days after the recall, the FDA issued a Safety Alert about Digitek to patients, primary-care physicians, cardiologists, pharmacists, and other healthcare professionals.
The FDA stated that it had received multiple reports of Digitek-related injuries and illnesses. The manufacturer of Digitek, the Iceland-based pharmaceutical company Actavis Group, also acknowledges that it had received reports of serious medical events related to Digitek treatment.
Digitek Side Effects
Even at the correct dosage, Digitek presents potential serious side effects. The specific Digitek side effects that have been observed following treatment with the double-dose Digitek include:
- bradycardia (abnormally slow heart beat)
- cardiac instability
- dizziness/lightheaded feeling
- hypotension (low blood pressure)
- nausea
- vomiting
If You Have Suffered a Digitek Side Effect
Dangerous drugs such as the recalled Digitek have harmed many thousands of people. Bring your questions and concerns about side effects Digitek to RODANAST, P.C., highly experienced defective drug attorneys who can help you obtain fair compensation for damages and losses due to Digitek. Contact us online today to schedule a private consultation.
