Digitek®, a Factory Built Prescription Error

Most of us have seen and heard news about prescription errors that have caused over 7,000 deaths, annually. However on April 25, 2008 Actavis Totowa, LLC, subsidiary of Iceland’s Actavis Group finally identified a very unusual problem. Actavis initiated a class I US Nationwide recall of its digoxin based cardiac drug,  Digitek®, a prescription drug that had a built-in error in all sizes of its digoxin pills.

The pills were twice as large, with twice the dosage of regular size digoxin pills. The trouble was that patients who took the variant Digitek® thought that nothing was extraordinary, and pharmacists thought that they were filling prescriptions for a normal dose and size. It seems that Digitek® distributors had not seen a need to conduct any additional inspections of Digitek® before normal distribution, and evidently for months, Actavis had not bothered to inspect the variant Digitek® pills as they were being manufactured.

Actavis’ lack of attention to a small detail, such as the actual size of the pills leaving the factory, led to thousands of cardiac patients suffering serious injury, and in many cases, death from digoxin overdose.

In a sense, Actavis had allowed the equivalent of a phantom robotic pharmacist to fill each and every future prescription the wrong way. Actavis personnel were oblivious to the fact that Digitek® pills were getting “welded” together during manufacture. Those pills were becoming twice as large in proportion to regular Digitek® pills, and with twice as much digoxin inside. But, nobody was there to catch the error.

If some pills, like aspirin, were produced at twice the size, and consumers took them once in a while for a headache, they would probably cause little harm, other than a transient upset stomach that might result. However, since the advent of digoxin, three centuries ago, physicians have known that they had to take extra caution in prescribing digoxin to patients, because the therapeutic dose was so close to the toxic range for digoxin. In other words, a small dosing error might be catastrophic.  In fact, doctors have long been aware that certain patients with kidney dysfunction might accumulate excess digoxin in their systems, and that they might suffer substantial injury or die as a result in as little time as one week.

Essentially, the oversized, renegade Digitek® pills that Actavis provided to pharmacies could turn every otherwise healthy patient, into patients with an equivalent kidney dysfunction. Those patients taking oversized Digitek® pills, who might already suffer kidney dysfunction, might be at risk of fatality.

For quite a while, Actavis manufactured the oversized Digitek® pills. As a result, doctors and hospitals were seeing patients who had been using digoxin, safely, for years, coming in for treatment complaining of horrific headaches. Patient s complained further that they were overly tired all of the time. However, their hearts might be racing along at 170 beats per minute. In addition, some patients were complaining of nausea, and dizziness, and of fainting happening after walking only a few blocks.

One 90-year old consumer called the double sized Digitek® pill a “horse pill.” The spry 90-year-old had been taken Digitek® for over a year and he had no idea why the manufacturer had suddenly and without comment, giant sized the pills.

When confronted with patients complaining of symptoms, some doctors just changed their prescription to another brand of digoxin, such as Lanoxin. The symptoms may have subsided for many, but for some patients, the aftermath of overdosing on Digitek® was damage to heart tissue.

For some patients who escaped diagnosis, the pendulum could swing fast in seven days from normalcy to death. Such devastation could manifest itself long before those patients would go for their periodic checkups, and in many cases, the penalty for taking the variant Digitek® was death.

Was the production of this oversized Digitek® pill an inadvertent hard to detect manufacturing error?

One federal lawsuit recently filed in Birmingham, Alabama charges that Actavis knew or should have known about such manufacturing and production defects. In fact, the lawsuit alleges that Actavis failed to heed FDA warnings in July and August 2006, and then again in February 2007, a warning that Actavis had been releasing adulterated, impure and miss-dosed pills to the public.

Certainly, the Digitek® consumer expects a detailed explanation of the reasons why the Actavis manufacturing misadventure with Digitek®, took place, and most importantly, further explanation why the Digitek® size and dose discrepancy went unnoticed for such a long period.