A class I nationwide recall of Digitek brand of digoxin tablets. Digitek is used to treat heart failure and abnormal heart rhythms. The voluntary recall of all lots is because some tablets with double thickness and double the labeled amount of active ingredient were released. Double-strength tablets pose a risk of toxicity, especially in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, and slow heart rate. Digoxin toxicity can lead to death. There have been several reports of illness but no fatalities. Consumer inquiries should be directed to Stericycle customer service at 1-888-276-6166. Additional information is available at http://www.actavis.us/. Medical questions should be directed to your doctor or pharmacist. Adverse reactions should be reported to the FDA's MedWatch Program at 1-800-FDA-1088 or on the website http://www.fda.gov/medwatch.

Another recent report involving the use of a prescription medication, Fosamax, indicates that women who have taken Fosamax to prevent osteoporosis are nearly twice as likely to develop an irregular heartbeat called atrial fibrillation than those who have never used the drug. Fosamax belongs to a class of drugs known as bisphosphonates used to prevent osteoporosis (bone loss). Atrial fibrillation can cause palpitations, fainting, fatigue, or congestive heart failure. It can also lead to blood clots and stroke. The risk of atrial fibrillation was a surprise finding in earlier studies of Fosamax, which lead to researchers investigating further. Women with confirmed atrial fibrillation beginning between 2001 and 2004 were compared to women the same age who did not atrial fibrillation. An 86% higher risk of atrial fibrillation was identified in women who took Fosamax than those who had never used it. Researchers say that there is not enough evidence to say that taking Fosamax is dangerous. Patients are advised not to stop taking Fosamax or other bisphosphonate drugs such as Actonel without first discussing it with their doctors because there aren't very many other good options to preventing osteoporosis. Researchers feel that for patients at high risk of fracture, the benefits of taking Fosamax outweigh the risk of atrial fibrillation; however, for those who only have a moderate risk of fracture and/or other risk factors for atrial fibrillations such as diabetes, coronary heart disease, or heart failure, the risk of using Fosamax may outweigh the benefits. At this point no action regarding the use of Fosamax will be taken but studies will continue.

References: http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html, http://seattlepi.nwsource.com/health/360903_bonedrug29.html?source=mypi.

[Return to Archive Index]

[PageTop]