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Review Treprostinil Safety Reports submitted to FDA

Total Treprostinil reports: 4.
Treprostinil FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 3.
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FDA Reported Treprostinil Side Effects: lower respiratory tract infection, syncope, sepsis, enterobacter infection, catheter related infection, waist circumference increased, pyrexia, platelet count decreased.
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Treprostinil Side Effects Report #5726057-3
Pharmacist from UNITED STATES reported TREPROSTINIL problem on May 01, 2008. Female patient, weighting 145.0 lb, was diagnosed with pulmonary hypertension and was treated with TREPROSTINIL. After drug was administered, patient experienced the following problems/side effects: bacterial sepsis, infusion related reaction. TREPROSTINIL dosage: unknown. During the same period patient was treated with SPIRONOLACTONE, OXYCODONE, ESTRADIOL, SILDENAFIL CITRATE, WARFARIN, BOSENTAN. Patient died on 04/23/2008.

Treprostinil Side Effects Report #5741178-7
TREPROSTINIL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 29, 2008. Female patient, 68 years of age, weighting 91.49 lb, was diagnosed with pulmonary arterial hypertension and was treated with TREPROSTINIL. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, anaemia, anoxic encephalopathy, cardiac failure congestive, cardio-respiratory arrest, crest syndrome, diarrhoea, haematemesis, hypoxia. TREPROSTINIL dosage: unknown. During the same period patient was treated with LEXAPRO, LASIX, SOTALOL, SALAGEN, SYNTHROID, COUMADIN, REVATIO, VITAMIN. Patient was hospitalized. Patient died.

Treprostinil Side Effects Report #5345074-9
Consumer or non-health professional from IRELAND reported TREPROSTINIL problem on May 18, 2007. Female patient, 68 years of age, was diagnosed with pulmonary hypertension and was treated with TREPROSTINIL. After drug was administered, patient experienced the following problems/side effects: lower respiratory tract infection. TREPROSTINIL dosage: unknown. During the same period patient was treated with ASPIRIN, BOSENTAN, PRAVASTATIN, LASIX, ALDACTONE, LANOXIN, ALLOPURINOL, SERETIDE. Patient was hospitalized. Patient recovered.

Treprostinil Side Effects Report #5265864-0
TREPROSTINIL problem was reported by a Physician from UNITED STATES on Mar 12, 2007. Male patient, 65 years of age, weighting 218.0 lb, was diagnosed with pulmonary hypertension and was treated with TREPROSTINIL. After drug was administered, patient experienced the following problems/side effects: catheter related infection, enterobacter infection, sepsis, syncope. TREPROSTINIL dosage: unknown. Patient was hospitalized. Patient recovered.


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