A heart medication sold by Mylan Laboratories in the US has had to be recalled, after it emerged that some doses may contain twice the intended dose of active ingredient.

Digitek (digoxin) is used to treat heart failure and cardiac arrhythmias, and the risk of adverse events with the drug is so serious that the US Food and Drug Administration (FDA) has take the unprecedented step of asking pharmacists to notify all patients who have been prescribed it.

In a statement, Actavis Totowa, which manufacturers the product on a contract basis for Mylan, said that double strength tablets could pose a risk of toxicity, particularly in patients with renal failure.

Digoxin – also known as digitalis – is known to cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia, and can be life-threatening at high doses.

“Several reports of illnesses and injuries have been received,” said Actavis in a statement, although it is not certain that these related to the current manufacturing problem. Digitek is sold by Mylan’s Bertek and UDL Laboratories affiliates.

The problem seems to stem from some Digitek tablets being made at twice the thickness – and with double the API – than the specification.

A spokesperson for the company told in-PharmaTechnologist.com that the investigation into the problem was still ongoing, but at the moment there was no further information on what caused it and how many tablets were involved.

This is not the first time that there have been manufacturing problems at the Actavis Totowa facility in New Jersey, which was acquired as part of the takeover of Amide Pharmaceuticals by Actavis in May 2005, although the spokesperson said these earlier issues were entirely unrelated to the current incident.

Just over a year ago Actavis Totowa was sent a warning letter by the FDA after an agency inspection revealed that drugs products manufactured in the facility were ‘adulterated’.

The quality control unit at the site came under criticism from the agency, which said it failed to reliably establish the identity, strength, quality and purity of drug products manufactured and released onto the market. The FDA inspectors also noticed a general lack of investigation of out-of-specification test results, as well as a lack of sufficient documentation of the results.

It is understood, however, that all these ‘Form 483’ issues have since been resolved to the agency’s satisfaction.

Actavis was also forced to recall all lots of its painkilling fentanyl patch products in March after it identified a possible fold-over defect present in the product that might cause leakage of the fentanyl gel. However, on this occasion the recalled patches were manufactured by Corium International, a contract manufacturer for Actavis.



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