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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Serious cases of gastrointestinal obstruction, ileus, and fecal impaction have been associated with lanthanum use, some requiring surgery or hospitalization. Risk factors include constipation and altered gastrointestinal anatomy. ( 2 , 5.1 ) • FOSRENOL has radio-opaque properties and therefore may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.2 ) 5.1 Gastrointestinal Adverse Effects There have been reports of serious cases of gastrointestinal obstruction, ileus, and fecal impaction reported in association with lanthanum, some requiring surgery or hospitalization. Risk factors for gastrointestinal obstruction identified from post-marketing reports include alteration in gastrointestinal anatomy (e.g., history of gastrointestinal surgery, colon cancer), hypomotility disorders (e.g., constipation, ileus, diabetes) and concomitant medications (e.g., calcium channel blockers). Some cases were reported in patients with no history of gastrointestinal disease. Advise patients to chew the tablet thoroughly to reduce the risk of adverse gastrointestinal events. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in FOSRENOL clinical studies [ See Contraindications (4) ]. 5.2 Diagnostic Tests FOSRENOL has radio-opaque properties and therefore may give the appearance typical of an imaging agent during abdominal X-ray procedures.
6 ADVERSE REACTIONS Overall, the safety profile of FOSRENOL has been studied in over 5200 subjects in completed clinical trials. The most common adverse reactions for FOSRENOL were gastrointestinal events, such as nausea and vomiting and they generally abated over time with continued dosing. • The most common reactions included: nausea, vomiting, diarrhea, and abdominal pain. ( 6.1 ) • The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, hypophosphatemia and tooth injury. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In double-blind, placebo-controlled studies where a total of 180 and 95 ESRD patients were randomized to FOSRENOL and placebo, respectively, for 4-6 weeks of treatment, the most common reactions that were more frequent ( > 5% difference) in the FOSRENOL group were nausea, vomiting, and abdominal pain (Table 1). Table 1. Adverse Reactions* That Were More Common on FOSRENOL in Placebo Controlled, Double-Blind Studies With Treatment Periods of 4-6 Weeks FOSRENOL % (N=180) Placebo % (N=95) Nausea 11 5 Vomiting 9 4 Abdominal pain 5 0 *expressed at the event rate for each term In an open-label long-term 2 year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment. The safety of FOSRENOL was studied in two long-term, open-labeled clinical trials, which included 1215 patients treated with FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of FOSRENOL treated patients discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea and vomiting were the most common types of event leading to discontinuation. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury.