"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
The safety of SKELID (tiludronate) has been studied in more than 1100 patients, and the adverse experience profile is similar between controlled and uncontrolled clinical trials. Adverse events occurring in placebo-controlled trials of pagetic patients treated with SKELID (tiludronate) 400 mg/day are presented in the table below.
Adverse events associated with SKELID (tiludronate) usually have been mild, and generally have not required discontinuation of therapy. In two placebo-controlled trials, 1.3% of patients receiving 400 mg SKELID (tiludronate) and 5.4% of patients receiving placebo discontinued therapy due to any clinical adverse event.
Adverse Eventsa (%) Reportedb in >
2% of Pagetic Patients from Placebo-Controlled Studies
| SKELID (tiludronate)
|BODY AS A WHOLE|
|Central and Peripheral Nervous Systems|
|Metabolic and Nutritional|
|Vitamin D Deficiency||2.7||2.7|
|Upper Respiratory Tract Infection||5.3||14.9|
|Skin and Appendage|
a Reported using WHO terminology
b All events reported, irrespective of causality
Other adverse events not listed in the table above but reported in ≥ 1% of pagetic patients treated with SKELID (tiludronate) in all clinical trials of at least one month duration, regardless of dose and causality assessment, are listed below. The adverse event terms within each body system are listed in the order of decreasing frequency occurring in the population.
Central and Peripheral Nervous Systems: Vertigo, involuntary muscle contractions
Musculoskeletal: Fracture pathological
Respiratory System: Bronchitis
Skin and Appendages: Pruritus, increased sweating
Urinary System: Urinary tract infection
Vascular (extracardiac): Flushing
Stevens-Johnson type syndrome has been observed rarely; the causality relationship of this to SKELID (tiludronate) has not been established.
Read the Skelid (tiludronate) Side Effects Center for a complete guide to possible side effects
The bioavailability of SKELID (tiludronate) is decreased 80% by calcium, when calcium and SKELID (tiludronate) are administered at the same time, and 60% by some aluminum- or magnesium-containing antacids, when administered 1 hour before SKELID (tiludronate) . Aspirin may decrease bioavailability of SKELID (tiludronate) by up to 50% when taken 2 hours after SKELID (tiludronate) . The bioavailability of SKELID (tiludronate) is increased 2-4 fold by indomethacin but is not significantly altered by coadministration of diclofenac. The pharmacokinetic parameters of digoxin are not significantly modified by SKELID (tiludronate) coadministration. In vitro studies show that tiludronate does not displace warfarin from its binding site on protein.
Read the Skelid Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/14/2010
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