FDA actions

The FDA has issued a warning regarding azithromycin and cardiac toxicity. The drug has been associated with fatal heart rhythms — especially in patients already at risk — including those with prolonged QT intervals, torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure. Other patients may be at risk as well, including those with low potassium or magnesium levels, those using drugs that prolong the QT intervals, and elderly patients with cardiac disease. The warning was based on a study published in The New England Journal of Medicine last year.

An FDA advisory committee is recommending against the use of calcitonin salmon (Miacalcin and Fortical nasal sprays, and Miacalcin injection) for the treatment of osteoporosis in postmenopausal women because the risk of cancer outweighs any potential benefit. The recommendation is based on an FDA review that questions the drug's effectiveness in reducing fractures. Another review found a small increased risk of cancer associated with the drug. The drug could still be used for Paget's disease, acute bone loss due to immobilization, and hypercalcemia. The FDA has yet to rule on the advisory committee's recommendations.