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Review Daptomycin Safety Reports submitted to FDA

Total Daptomycin reports: 10.
Daptomycin FDA safety alerts: 2008 .
   Reported hospitalizations: 4.
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FDA Reported Daptomycin Side Effects: blood creatine phosphokinase increased, rhabdomyolysis, skin exfoliation, rash erythematous, fall, rash, pruritus, erythema, myositis, xerosis, skin ulcer.
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Daptomycin Side Effects Report #5669525-5
Pharmacist from UNITED STATES reported DAPTOMYCIN problem on Mar 12, 2008. Male patient, 69 years of age, weighting 200.0 lb, was diagnosed with streptococcal infection and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: eosinophilic pneumonia. DAPTOMYCIN dosage: 600 MG Q24HRS IV. Patient recovered.

Daptomycin Side Effects Report #5676658-6
DAPTOMYCIN problem was reported by a Pharmacist from UNITED STATES on Mar 20, 2008. Male patient, 64 years of age, weighting 160.0 lb, was diagnosed with endocarditis bacterial and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. DAPTOMYCIN dosage: 500MG Q24H IV. Patient recovered.

Daptomycin Side Effects Report #5684476-8
Pharmacist from UNITED STATES reported DAPTOMYCIN problem on Mar 27, 2008. Male patient, 64 years of age, weighting 160.0 lb, was diagnosed with endocarditis bacterial and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. DAPTOMYCIN dosage: 500 MG Q24H IV. Patient recovered.

Daptomycin Side Effects Report #5625546-X
DAPTOMYCIN problem was reported by a Pharmacist from UNITED STATES on Feb 11, 2008. Male patient, 56 years of age, weighting 460.8 lb, was diagnosed with staphylococcal bacteraemia and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, blood creatinine increased. DAPTOMYCIN dosage: 1000 MG Q24H IV. Patient recovered.

Daptomycin Side Effects Report #5629411-3
Health Professional from UNITED STATES reported DAPTOMYCIN problem on Feb 15, 2008. Female patient was diagnosed with osteomyelitis and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: pruritus, rash macular. DAPTOMYCIN dosage: DAPTOMYCIN 4MG IV QD. During the same period patient was treated with CEFEPIME. Patient recovered.

Daptomycin Side Effects Report #5534243-0
DAPTOMYCIN problem was reported by a Pharmacist from UNITED STATES on Dec 03, 2007. Male patient, weighting 258.2 lb, was diagnosed with staphylococcal infection and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. DAPTOMYCIN dosage: 700MG Q 24 IVPB. Patient was hospitalized. Patient recovered.

Daptomycin Side Effects Report #5546454-9
Pharmacist from UNITED STATES reported DAPTOMYCIN problem on Dec 06, 2007. Female patient, 84 years of age, weighting 198.9 lb, was diagnosed with cellulitis and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, haemodialysis. DAPTOMYCIN dosage: 500 MG Q24H IV DRIP. During the same period patient was treated with ZOSYN, VANCOMYCIN. Patient was hospitalized. Patient recovered.

Daptomycin Side Effects Report #5518290-0
DAPTOMYCIN problem was reported by a Pharmacist from UNITED STATES on Nov 13, 2007. Female patient, 67 years of age, was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: respiratory failure, rhabdomyolysis. DAPTOMYCIN dosage: 360 MG DAILY IV. During the same period patient was treated with CEFEPIME, METHYLPREDNISOLONE, IPATROPIUM, ALBUTEROL. Patient was hospitalized. Patient recovered.

Daptomycin Side Effects Report #5493170-8
Physician from UNITED STATES reported DAPTOMYCIN problem on Oct 22, 2007. Female patient, weighting 123.5 lb, was diagnosed with bacteraemia and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: lung infiltration, oxygen saturation decreased. DAPTOMYCIN dosage: 330 MG Q 24 HRS IV. During the same period patient was treated with RIFAMPIN, PYRIDIUM, PROTONIX, COUMADIN, MEGACE, NORCO, DILTIAZEM, ADVAIR DISKUS. Patient was hospitalized and became disabled. Patient recovered.

Daptomycin Side Effects Report #5503746-7
DAPTOMYCIN problem was reported by a Pharmacist from UNITED STATES on Oct 29, 2007. Female patient, 62 years of age, weighting 273.4 lb, was diagnosed with bacteraemia and was treated with DAPTOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. DAPTOMYCIN dosage: 800 MG IV EVERY 48 HOURS. Patient recovered.


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