Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1) ] In controlled trials, the most common adverse reactions that were more frequent (≥ 5% difference vs.
placebo) in lanthanum carbonate were nausea, vomiting, and abdominal pain.
( 6.1 ) The following adverse reactions have been identified during post-approval use of lanthanum carbonate: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet.
( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan pharmaceutical,Inc.
at 1-866-604-3268 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 the 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.
Overall, the safety profile of Lanthanum carbonate chewable tablets has been studied in over 5,200 subjects in completed clinical trials.
The most common adverse reactions for Lanthanum carbonate chewable tablets were gastrointestinal events,such as nausea,vomiting and abdominal pain and they generally abated over time with continued dosing.
In double-blind, placebo-controlled studies where a total of 180 and 95 patients with ESRD were randomized to lanthanum carbonate chewable tablet and placebo, respectively, for 4 to 6 weeks of treatment, the most common reactions that were more frequent (≥5% difference) in the lanthanum carbonate group were nausea, vomiting, and abdominal pain (Table 1).
Adverse Reactions * That Were More Common on Lanthanum Carbonate in Placebo-Controlled, Double-Blind Studies with Treatment Periods of 4 to 6 Weeks LANTHANUM CARBONATE % (N=180) Placebo % (N=95) Nausea 11 5 Vomiting 9 4 Abdominal Pain 5 0 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.
5 WARNINGS AND PRECAUTIONS Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction.
Risks include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications.
Advise patients to chew or crush the tablet completely.
( 5.1 ) Lanthanum carbonate 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 Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction have been reported in patients taking lanthanum, some requiring surgery or hospitalization.
Like all medications, Lanthanum Carbonate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: