SIDE EFFECTS
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 CHEMET, i.e., gastrointestinal symptoms or increases in serum transaminases, have been observed in about 10% of patients. 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 CHEMET. Rechallenge with CHEMET may be considered if lead levels are high enough to warrant retreatment. Allergic reactions including urticaria and angioedema have been reported on repeated administration of the drug. Mild to moderate neutropenia has been observed in some patients receiving CHEMET. Table I presents adverse events reported with the administration of CHEMET for the treatment of lead and other heavy metal intoxication.
TABLE I INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES REGARDLESS OF ATTRIBUTION OR CHEMET 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. | ||||
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SRC: NLM .