Actavis orders recall of digoxin tablets

In some cases, patients were receiving twice the recommended dose.

A manufacturing division of the Actavis Group pharmaceutical company has issued a voluntary class I nationwide recall of its oral digoxin tablets, 0.125 mg and 0.25 mg.

The recall was instituted after it was discovered by the manufacturer that certain lots of the drug may have been infused with twice the amount of active ingredient than approved for the individual doses. Digoxin (Digitek, Actavis) is used to treat HF and abnormal heart rhythms.

The doubled level of medication poses a risk for digitalis toxicity in patients with renal failure. Adverse effects of digitalis include nausea, vomiting, dizziness, low BP, cardiac instability and bradycardia. Death can also occur from excessive levels of digitalis toxicity. According to a press release, several injuries resulting from ingestion of the drug have been reported. – by Eric Raible

During the last couple of years, patients’ dosages of digoxin have generally been decreased. There has been a lot of data coming out suggesting that lower doses were safer than higher doses. It used to be that everybody would get 0.25 mg daily of digoxin. During the years, lots of patients have been dropped down to 0.125 mg. Theoretically, if the patient was already receiving a 0.25 mg per day dose and it doubled up to 0.5 mg, it could perhaps place the patient at greater risk for digitoxicity. From my perspective, however, I just have not seen an increase in hospital admissions or presentations to clinic for symptoms that would make me think digitoxicity was present.

– James B. Young, MD
Cardiology Today Section Editor