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warnings
WARNINGS SKELID, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when SKELID is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers). Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue SKELID and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6–8oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION ). In patients who cannot comply with dosing instructions due to mental or physical disability, therapy with SKELID should be used under appropriate supervision. There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.
ADVERSE REACTIONS The safety of SKELID 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 400 mg/day are presented in the table below. The most frequently occurring adverse events in patients who received SKELID 400 mg/day were in the gastrointestinal body system: nausea (9.3%), diarrhea (9.3%), and dyspepsia (5.3%). Adverse events associated with SKELID 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 and 5.4% of patients receiving placebo discontinued therapy due to any clinical adverse event. Adverse Events Reported using WHO terminology (%) Reported All events reported, irrespective of causality in > 2% of Pagetic Patients from Placebo-Controlled Studies SKELID 400 mg/day (n=75) Placebo (n=74) BODY AS A WHOLE Pain 21.3 23.0 Back Pain 8.0 8.1 Accidental Injury 4.0 2.7 Influenza-like Symptoms 4.0 5.4 Chest Pain 2.7 0 Peripheral Edema 2.7 1.4 CARDIOVASCULAR, GENERAL Dependent Edema 2.7 0 Central and Peripheral Nervous Systems Headache 6.7 12.2 Dizziness 4.0 6.8 Paresthesia 4.0 0 ENDOCRINE Hyperparathyroidism 2.7 0 GASTROINTESTINAL Diarrhea 9.3 4.1 Nausea 9.3 5.4 Dyspepsia 5.3 8.1 Vomiting 4.0 0 Flatulence 2.7 0 Tooth Disorder 2.7 1.4 Metabolic and Nutritional Vitamin D Deficiency 2.7 2.7 Musculoskeletal System Arthralgia 2.7 5.4 Arthrosis 2.7 0 Resistance Mechanism Infection 2.7 0 Respiratory System Rhinitis 5.3 0 Sinusitis 5.3 1.4 Upper Respiratory Tract Infection 5.3 14.9 Coughing 2.7 2.7 Pharyngitis 2.7 1.4 Skin and Appendage Rash 2.7 1.4 Skin Disorder 2.7 1.4 Vision Cataract 2.7 0 Conjunctivitis 2.7 0 Glaucoma 2.7 0 Other adverse events not listed in the table above but reported in ≥1% of pagetic patients treated with SKELID 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. Body as a Whole: Asthenia, syncope, fatigue Cardiovascular: Hypertension Central and Peripheral Nervous Systems: Vertigo, involuntary muscle contractions Gastrointestinal: Abdominal pain, constipation, dry mouth, gastritis Musculoskeletal: Fracture pathological Psychiatric: Anorexia, somnolence, anxiety, nervousness, insomnia 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 has not been established.