News

Digoxin Has Been Recalled!

A Class I recall was issued on April 25, 2008 by the FDA on all Digitek® (digoxin tablets, USP, all strengths) for oral use, manufactured by Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Digoxin is a heart medicine that is often prescribed for heart rhythm disturbances (atrial fibrillation and atrial flutter) and to treat heart failure. To make the problem more complicated, the drug is distributed by two companies: Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.

The voluntary recall is due to the possibility that tablets which may contain twice the approved level of digoxin may have been commercially released. This is of particular concern because digitalis toxicity is a well-recognized potentially life-threatening complication of digoxin therapy, even in the absence of overly strong pills. Taking double the amount could therefore more easily lead to an overdose situation. This would be especially likely in someone who also has kidney failure.

The syndrome of digoxin toxicity was described for the first time in 1785. Clinical toxicity results from the interactions between digitalis, various electrolyte abnormalities, and their combined effect on the Na+/K+ ATPase pump. It can be caused by either high level of digitalis in the body, or decrease tolerance to the drug.

Approximately 0.4% of all hospital admissions, 1.1% of outpatients on digoxin, and 10% - 18% of nursing home patients develop toxicity. Morbidity is usually 4.6 – 10%, and if the digoxin level is greater than 6 ng/mL the morbidity is as high as 50%. Older people have a worse outcome than adults and children. Toxicity symptoms include:

1. weakness, fatigue;
2. Cardiovascular: rapid or slow heart rate, syncope, dyspnea, irregular pulse, low blood pressure. Cardiac arrest from asystolic or ventricular fibrillation is usually fatal;
3. Central nervous system: confusion and somnolence, dizziness, agitation, delirium, hallucination, headache, seizures (very rare), and neuropathic pain;
4. Ocular: changes in color vision with a tendency to yellow-green coloring, blurred vision and diplopia, halos or rings around objects, blind spots in vision and photophobia. Although visual changes occur, the pupils are spared; and
5. Gastrointestinal: Nausea, vomiting, anorexia, and diarrhea, loss of appetite, and abdominal pain.

Measurement of serum digoxin concentrations can be helpful to the clinician in determining the adequacy of digoxin therapy and in assigning certain probabilities to the likelihood of digoxin intoxication. About two-thirds of adult patients with clinical toxicity y have serum digoxin concentrations greater than 2 ng/mL. However, since one third of patients with clinical toxicity have concentrations less than 2 ng/mL, values below 2 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy. In acute toxicity, the digoxin level should be repeated after 2-4 hours to guide therapy; and keep in mind that digoxin levels do not equilibrate quickly because of variable absorption and subsequent tissue distribution. Toxicity is related to intracellular levels, not serum levels; and high level drawn within 4 hours of an acute ingestion may be incredibly high with no apparent clinical toxicity. The best way to guide therapy is to follow the digoxin level and correlate it with serum potassium concentrations and the patient's clinical and ECG findings. Other tests recommended to monitor the patients are: Na+, K+, Cl-, CO2-, Mg++, Ca++, BUN, creatinine levels, and cardiac markers if myocardial infarction is a clinical concern. The outcome varies depending on the extent of the toxicity and the symptoms specially the arrythmias.

Patients taking Digitek should contact their physician immediately for medical advice. Further consultation with your pharmacy provider is warranted. Any adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852, or on the MedWatch website at WWW.fda.gov/medwatch.

References:

1. FDA 2008 Medical Product Safety Alerts.
2. Steiner JF, Robbins LJ, Hammermeister KE, et al. Incidence of digoxin toxicity in outpatients. West J Med. Nov 1994;161(5):474-8
3. Lacy CF, Armstrong LL, Goldman MP. Drug Information Handbook. 13th ed. 2005.

Workplace Violence

On January 3, 2008 Governor Corzine mandated the development of a Health Care Committee to monitor all incidents or acts of violence in the health care setting beginning July 3, 2008. In that regard, Aculabs is developing a protocol and retaining records of all incidents of violence both verbal and physical vis-à-vis the phlebotomy service we provide to your nursing facility in relation to the residents, as well as the care givers.

As you develop your protocols, please provide us with a copy of the relevant polices.

Aculabs will be providing to our staff training on identifying and reporting violent or inappropriate behavior and will share that information with you, as appropriate.