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Review Diprostene Safety Reports submitted to FDA

Total Diprostene reports: 9.
Diprostene FDA safety alerts: No.
   Reported hospitalizations: 6.
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FDA Reported Diprostene Side Effects: paraesthesia, pallor, ocular hyperaemia, malaise, erythema, skin lesion, sciatica, herpes zoster disseminated.
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Diprostene Side Effects Report #5650425-1
Physician from FRANCE reported DIPROSTENE problem on Feb 28, 2008. Female patient, 68 years of age, was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. DIPROSTENE dosage: unknown. Patient recovered.

Diprostene Side Effects Report #5650579-7
DIPROSTENE problem was reported by a Consumer or non-health professional from FRANCE on Feb 25, 2008. Female patient, 53 years of age, was diagnosed with tendonitis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. DIPROSTENE dosage: 7 MG;ONCE;PERIA. Patient was hospitalized. Patient recovered.

Diprostene Side Effects Report #5619277-X
Consumer or non-health professional from FRANCE reported DIPROSTENE problem on Jan 30, 2008. Female patient, 53 years of age, was diagnosed with tendonitis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, skin test positive. DIPROSTENE dosage: 7 MG; ONCE; PERIA. Patient was hospitalized. Patient recovered.

Diprostene Side Effects Report #5639177-9
DIPROSTENE problem was reported by a Consumer or non-health professional from FRANCE on Feb 18, 2008. Female patient, 53 years of age, was diagnosed with tendonitis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, blood pressure increased, heart rate increased, hypotension, oedema peripheral, pruritus, rash maculo-papular, skin plaque, skin test positive. DIPROSTENE dosage: 7 MG; ONCE; PERIA. Patient was hospitalized. Patient recovered.

Diprostene Side Effects Report #5508657-9
Physician from FRANCE reported DIPROSTENE problem on Oct 31, 2007. Female patient, 53 years of age, was diagnosed with tendonitis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, blood pressure systolic increased, oedema peripheral, rash maculo-papular. DIPROSTENE dosage: 7 MG; ONCE; IA. Patient was hospitalized. Patient recovered.

Diprostene Side Effects Report #5486024-4
DIPROSTENE problem was reported by a Physician from FRANCE on Oct 10, 2007. Female patient, 53 years of age, was diagnosed with tendonitis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: hypotension, oedema peripheral, pruritus. DIPROSTENE dosage: unknown. Patient was hospitalized. Patient recovered.

Diprostene Side Effects Report #5754046-1
Consumer or non-health professional from FRANCE reported DIPROSTENE problem on May 15, 2008. Female patient, 57 years of age, was diagnosed with pain and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: bronchitis, erythema, fatigue, heart rate increased, hypercholesterolaemia, hyperglycaemia, hyperthyroidism, localised oedema, palpitations. DIPROSTENE dosage: unknown. Patient recovered.

Diprostene Side Effects Report #5755689-1
DIPROSTENE problem was reported by a Consumer or non-health professional from FRANCE on May 15, 2008. Female patient, 57 years of age, was diagnosed with pain and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: bronchitis, fatigue, heart rate increased, hypercholesterolaemia, hyperglycaemia, hypersensitivity, hyperthyroidism. DIPROSTENE dosage: unknown. Patient recovered.

Diprostene Side Effects Report #5343434-3
Physician from FRANCE reported DIPROSTENE problem on May 23, 2007. Female patient, 73 years of age, was diagnosed with sciatica, rheumatoid arthritis and was treated with DIPROSTENE. After drug was administered, patient experienced the following problems/side effects: herpes zoster disseminated, sciatica, skin lesion. DIPROSTENE dosage: unknown. During the same period patient was treated with ENBREL, METHOTREXATE. Patient was hospitalized. Patient recovered.


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