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Review Cinacalcet Safety Reports submitted to FDA

Total Cinacalcet reports: 8.
Cinacalcet FDA safety alerts: No.
   Reported hospitalizations: 8.
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FDA Reported Cinacalcet Side Effects: joint injury, hypocalcaemia, convulsion, angioneurotic oedema, rash maculo-papular, platelet count decreased, pancytopenia, kidney transplant rejection, haemoglobin decreased, granulocytes maturation arrest, febrile bone marrow aplasia.
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Cinacalcet Side Effects Report #5657888-6
Physician from UNITED STATES reported CINACALCET problem on Feb 25, 2008. Male patient, weighting 131.2 lb, was diagnosed with hyperparathyroidism secondary and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: electrocardiogram st segment depression, hypersensitivity. CINACALCET dosage: unknown. During the same period patient was treated with PHENERGAN, LISINOPRIL, NEXIUM, LIPITOR, QUININE SULPHATE. Patient was hospitalized. Patient recovered.

Cinacalcet Side Effects Report #5607659-1
CINACALCET problem was reported by a Physician from UNITED STATES on Jan 28, 2008. Female patient, weighting 211.6 lb, was diagnosed with hyperparathyroidism secondary and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: gastritis, mallory-weiss syndrome, upper gastrointestinal haemorrhage. CINACALCET dosage: 90 MG DAILY PO. Patient was hospitalized. Patient recovered.

Cinacalcet Side Effects Report #5418061-X
Health Professional from reported CINACALCET problem on Aug 06, 2007. Female patient, 53 years of age, weighting 249.1 lb, was diagnosed with hyperparathyroidism secondary and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: convulsion, hypocalcaemia, joint injury. CINACALCET dosage: unknown. During the same period patient was treated with ALFACALCIDOL, AQUEOUS CREAM, BECLOMETHASONE DIPROPIONATE, CALCICHEW, CODEINE PHOSPHATE AND ACETAMINOPHEN, FOLIC ACID, OMEPRAZOLE, PAROXETINE. Patient recovered.

Cinacalcet Side Effects Report #5743287-5
CINACALCET problem was reported by a Physician from UNITED STATES on May 08, 2008. Male patient, weighting 110.0 lb, was diagnosed with hyperparathyroidism secondary and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arthralgia, hypoglycaemia, nausea, pancreatitis chronic, vomiting. CINACALCET dosage: unknown. During the same period patient was treated with NEURONTIN, LANTUS, COUMADIN, ATIVAN. Patient was hospitalized. Patient recovered.

Cinacalcet Side Effects Report #5754396-9
Physician from UNITED STATES reported CINACALCET problem on May 19, 2008. Male patient, weighting 110.0 lb, was diagnosed with hyperparathyroidism secondary and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arthralgia, hypoglycaemia, nausea, pancreatitis chronic, vomiting. CINACALCET dosage: unknown. During the same period patient was treated with NEURONTIN, LANTUS, COUMADIN, ATIVAN, CALCIUM ACETATE. Patient was hospitalized. Patient recovered.

Cinacalcet Side Effects Report #5368639-7
CINACALCET problem was reported by a Health Professional from UNITED KINGDOM on June 13, 2007. Male patient, 54 years of age, was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: rash maculo-papular. CINACALCET dosage: unknown. During the same period patient was treated with ASPIRIN, CLOPIDOGREL, DEXAMETHASONE, METOPROLOL SUCCINATE, OMEPRAZOLE, PHENYTOIN. Patient recovered.

Cinacalcet Side Effects Report #5289347-7
Consumer or non-health professional from FRANCE reported CINACALCET problem on Mar 26, 2007. Female patient, 62 years of age, weighting 125.7 lb, was diagnosed with cytomegalovirus infection, prophylaxis against transplant rejection and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, cytomegalovirus infection, diarrhoea, febrile bone marrow aplasia, granulocytes maturation arrest, haemoglobin decreased, kidney transplant rejection, pancytopenia, platelet count decreased. CINACALCET dosage: unknown. During the same period patient was treated with ALDACTONE, ROVALCYTE, NEORAL, MYFORTIC, PROGRAF. Patient was hospitalized. Patient recovered.

Cinacalcet Side Effects Report #5255217-3
CINACALCET problem was reported by a Health Professional from UNITED KINGDOM on Feb 22, 2007. Female patient, 52 years of age, weighting 262.4 lb, was diagnosed with pre-existing disease and was treated with CINACALCET. After drug was administered, patient experienced the following problems/side effects: nephrotic syndrome, proteinuria. CINACALCET dosage: unknown. During the same period patient was treated with ALLOPURINOL, ATORVASTATIN, AUGMENTIN, BECLOMETHASONE DIPROPIONATE, CHLORPHENIRAMINE MALEATE, DOXYCYCLINE, EZETIMIBE, FLUOXETINE. Patient recovered.


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