Revised Labeling & Warnings for Hospice Medications
Posted by Dr. Julia Harder
Revised Proton Pump Inhibitors Labeling
The FDA has revised labeling for prescription and OTC proton pump inhibitors (PPIs), to include new safety information about a possible increased risk of hip, wrist, and spine fracture associated with the use of these medications. The new safety information is based on the FDA's review of 7 epidemiological studies that found those at greatest risk for these fractures received high doses of PPIs or had used them for 1 year or more. The majority of the studies evaluated individuals 50 years of age and older, with increased fracture risk primarily observed in this age group. However, randomized clinical trials of PPIs have not found an increased risk of fracture of the hip, wrist, or spine.
Revised Warning Sections for Ultram and Ultracet
Ortho-McNeil-Janssen and the FDA are notifying health care professionals of changes to the Warnings section of the prescribing information for Ultram (tramadol) and Ultracet (tramadol/acetaminophen). The revised information highlights the risk of suicide for patients who are addiction prone or taking tranquilizers or antidepressant drugs, as well as the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbance or suicidal ideation or attempts, as well as in those who have previously misused tranquilizers, alcohol, and other CNS-active drugs.