Digitek Tablets Recalled as They May Contain a Dangerous Double Dose of the Active Ingredient

On April 25, 2008, Actavis Totowa LLC issued a Class 1 nationwide recall of all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP, all strengths) for oral use because the heart treatment pills may contain two times the proper dosage of the drug’s active ingredient, digoxin.

Digitek, a generic form of digoxin, is a prescription oral pill used to treat heart failure and abnormal heart rhythms by making the heart beat more efficiently.  Digitek accounts for about one-half of all the digoxin in the U.S. market.

Double-strength tablets pose a risk of digitalis toxicity, which can cause nausea, vomiting, dizziness, abnormal vision, low blood pressure, cardiac instability, irregular or slow heart rate, and death, according to the Recall Notice.

"Tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate," states an Actavis Totowa news release posted on the FDA's web site.

Actavis Totowa also said that these high levels of digoxin pose a risk of digitalis toxicity in patients with renal failure who, unlike other patients, are unable to discharge digitalis from their bodies.

Digitek is manufactured by Actavis Totowa LLC, a United States manufacturing division of the Iceland-based generic pharmaceutical company Actavis Group. It is distributed by Mylan Pharmaceuticals Inc. and sold under the label "Bertek." It is also distributed by UDL Laboratories Inc. and sold under the label "UDL."

All lots of Digitek were recalled.

Adverse Reports Confirmed

Actavis now maintains that it recalled Digitek out of an “abundance of caution” and that none of the defective pills ever reached the public.  Recent data released by the Food and Drug Administration, however, indicate that Digitek could in fact be the primary suspect in 667 reports of deaths attributed to Digitek.

The accounts were reported by heath consumers and care professionals, between April 1 and June 30 of 2008, to the FDA’s Adverse Events Reporting System (AERS).  The FDA has confirmed these reports but remains skeptical of their connection to Digitek, since the reports could have been attributed to many other factors, such as an exaggerated response to a public recall or a patient’s underlying condition.

Still, experts say, the overwhelming number of reports should have, at the very least, served as a sign to the FDA that additional investigation was needed.

FDA: All Warning, No Action

The FDA’s treatment of the Digitek saga has been a source of great criticism amongst health and public officials.  Many believe that the danger posed by the defective tablets could have been avoided if the FDA acted years ago, when it first uncovered significant deficiencies in the facility used to manufacture the tablets.

According to the Center for Public Integrity, a non-profit and non-partisan investigative group, the FDA had concerns about Actavis as far back as 2006 when the agency uncovered unsound manufacturing practices and quality control violations after inspecting three Actavis Totowa plants in New Jersey.

In a letter sent to Actavis the FDA stated, “there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the integrity, strength, quality and purity that they purport to possess.”

Still, even after reprimanding Actavis for serious violations, the FDA did nothing to halt the production or manufacturing of potentially deadly product.  According to the FDA, Actavis chose to voluntarily recall all the products manufactured at this facility, including the double-thick Digitek tablets, after questions regarding the deficiencies were raised.  What the Agency fails to point out though, is that the recall came almost three years after the initial inspection found problems.

What Recall?

The FDA labeled the Digitek recall as a Class 1 recall, which is the most serious type issued by the agency, usually reserved for drugs that can lead to serious injury or death.  What critics found surprising though was the lack of publicity surrounding the recall, despite its severity.

Critics believe that neither Actavis nor the FDA did their best to assure that the public and health providers were notified of the danger.  The FDA never held a press conference and it failed to issue its own news release on the recall.  Also, neither Actavis nor the FDA sent warning letters alerting physicians of the danger.

The recall unfortunately comes too late for the patients and families whose loved ones unknowingly were overdosed by ingesting the potentially deadly tablets.

Well known cardiovascular epidemiologist and former FDA advisor Curt Furberg said that FDA’s handling of Actavis indicated a “total failure of the system to oversee the production of medications and follow up on recalls,” adding that the FDA “should have issued an alert or asked the manufacturer to issue an alert to be sent to all physicians.”

Furberg also showed concern that no one has yet tracked or accounted for the millions of double-dose pills affected by the recall.  He claims that many potentially “poisonous pills” could still be sitting in medicine cabinets and shelves. 

Officials React

Four months after the controversial recall, the House Energy and Commerce Committee began an investigation into the alleged FDA shortcomings regarding Actavis.  Congressman John Dingell, D-Mich., chairman of the committee, and Bart Stupak, D-Mich., chairman of its oversight subcommittee, wrote a letter to the FDA on October 8, 2008, asking for records regarding the agency’s history with Actavis in an effort to determine “whether the FDA permitted additional products from this firm onto the market while the agency knew or should have known about the breakdown of manufacturing practices at Actavis or its subsidiaries.”

Both the FDA and Actavis maintain that reports of injuries posted on the FDA’s AERS website are not proof that patients were harmed by Digitek.  Outside experts remain concerned as the investigation into the recall continues.

To report side effects to the FDA, call the FDA’s hotline at 800-FDA-1088 or visit the FDA's MedWatch web site

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