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Clinical experience with CHEMET has been limited. Consequently, the full spectrum and incidence of adverse reactions including the possibility of hypersensitivity or idiosyncratic reactions have not been determined. The most common events attributable to succimer, i.e., gastrointestinal symptoms or increases in serum transaminases, have been observed in about 10% of patients (see PRECAUTIONS). Rashes, some necessitating discontinuation of therapy, have been reported in about 4% of patients. If rash occurs, other causes (e.g. measles) should be considered before ascribing the reaction to succimer. Rechallenge with succimer may be considered if lead levels are high enough to warrant retreatment. One allergic mucocutaneous reaction has been reported on repeated administration of the drug (see PRECAUTIONS). Mild to moderate neutropenia has been observed in some patients receiving succimer (see WARNINGS). Table I presents adverse events reported with the administration of succimer for the treatment of lead and other heavy metal intoxication.

TABLE I : INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES REGARDLESS OF ATTRIBUTION OR SUCCIMER DOSAGE

  Pediatric Patients (191) Adults (134)
% (n) % (n)
Digestive: 12.0 23 20.9 28
Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, loose stools, metallic taste in mouth.
Body as a Whole: 5.2 10 15.7 21
Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis.
Metabolic: 4.2 8 10.4 14
Elevated SGPT, SGOT, alkaline phosphatase, elevated serum cholesterol.
Nervous: 1.0 2 12.7 17
Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia.
Skin and Appendages: 2.6 5 11.2 15
Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritus.
Special Senses: 1.0 2 3.7 5
Cloudy film in eye, ears plugged, otitis media, eyes watery.
Respiratory 3.7 7 0.7 1
Throat sore, rhinorrhea, nasal congestion, cough.
Urogenital: 0.0 - 3.7 5
Decreased urination, voiding difficulty, proteinuria increased.
Cardiovascular: 0.0 1.8 2
Arrhythmia
Heme/Lymphatic: 0.5* 1 1.5* 2
Mild to moderate neutropenia, increased platelet count, intermittent eosinophilia.
Musculoskeletal: 0.0 3.0 4
Kneecap pain, leg pains.
*Does not include neutropenia - see WARNINGS.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-755-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.