Clinical drug investigation
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Randomized Controlled Trial
Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial.
Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years. ⋯ This 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.
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A 62-year-old man with no drug allergies was admitted for coronary artery bypass grafting. Postoperatively, metoclopramide was commenced for the treatment of gastroparesis. Ten days after the drug was initiated a purpuric rash was noticed on his lower limbs. ⋯ The rash later began to subside upon discontinuation of metoclopramide. A rechallenge was not attempted for ethical reasons. In conclusion, metoclopramide was considered to be the causative agent of this rash as it subsided after the discontinuation of metoclopramide.