The drug manufacturer Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The defective drug is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a serious risk of digitalis toxicity in patients with renal failure. Symptoms of digitalis toxicity include: nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported to the FDA. Patients should contact their healthcare professional with questions regarding this medication.

Evidence is emerging to suggest that patients need to be alert to the fact that combining nonsteroidal anti-inflammatory pain medications (NSAIDs) such as ibuprofen (ADVIL) and naproxen (ALEVE) with a class of osteoporosis drugs called bisphosphonates, such as alendronate (FOSAMAX), etidronate (DIDR¬ONEL), ibandronate (BONIVA) and risedronate (ACTONEL) may result in an increased risk of ulcers and other gastrointestinal side effects and complications.

In the article, “Preserving Bones with Bisphosphonates: Should You Avoid NSAIDs?”- Worst Pills Best Pills, one randomized study of 26 healthy subjects looked for stomach ulcers in people who were given three short-term (10-day) treatments with alendronate, naproxen, and both together. Subjects were given all treatments with a one-to four-week washout between each. Eight percent of the people who took alendronate alone developed a stomach ulcer, and 12 percent of patients who took naproxen alone also developed a stomach ulcer. The study found that 38 percent of patients who took the two drugs together developed a stomach ulcer. There was a dramatic increase in the risk of stomach ulcers, demonstrating what is called synergism between the two drugs.

A larger study also examined the medical records of 242 patients who had received NSAID therapy for rheumatoid arthritis over a three-month period and found that over 30 percent of the patients receiving bisphosphonates along with their NSAID therapy had developed gastrointestinal ulcers, compared to 17 percent in those who received NSAIDs alone.