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Review Oxandrin Safety Reports submitted to FDA

Total Oxandrin reports: 7.
Oxandrin FDA safety alerts: 2004 .
Reported deaths: 2    Reported hospitalizations: 5.
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FDA Reported Oxandrin Side Effects: disease progression, ascites, hypoxia, pneumonia, nausea, dyspnoea, head injury, fall, oedema peripheral, anaemia, death.
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Oxandrin Side Effects Report #5475663-2
Health Professional from UNITED STATES reported OXANDRIN problem on Sept 20, 2007. Female patient, 82 years of age, weighting 95.00 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: confusional state, delirium, gait disturbance, urinary incontinence. OXANDRIN dosage: unknown. During the same period patient was treated with CIPROFLOXACIN, ETHAMBUTOL, ROBITUSSIN. Patient was hospitalized. Patient recovered.

Oxandrin Side Effects Report #5399923-9
OXANDRIN problem was reported by a Health Professional from UNITED STATES on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: anaemia, ascites, disease progression, gastric cancer. OXANDRIN dosage: 10MG BID PO. During the same period patient was treated with NIFEREX, ALDACTONE, PHENERGAN, PRILOSEC, VITAMIN CAP, REGLAN, LASIX, IMODIUM. Patient was hospitalized. Patient recovered.

Oxandrin Side Effects Report #5399926-4
Health Professional from UNITED STATES reported OXANDRIN problem on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: ascites, disease progression, transient ischaemic attack. OXANDRIN dosage: 10MG BID PO. During the same period patient was treated with NIFEREX, ALDACTONE, PHENERGAN, PRILOSEC, VITAMIN CAP, REGLAN, LASIX, IMODIUM. Patient was hospitalized. Patient recovered.

Oxandrin Side Effects Report #5399935-5
OXANDRIN problem was reported by a Health Professional from UNITED STATES on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: disease progression. OXANDRIN dosage: 10 MG BID PO. Patient died on 06/09/2007.

Oxandrin Side Effects Report #5399923-9
Health Professional from UNITED STATES reported OXANDRIN problem on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: anaemia, ascites, disease progression, gastric cancer. OXANDRIN dosage: 10MG BID PO. During the same period patient was treated with NIFEREX, ALDACTONE, PHENERGAN, PRILOSEC, VITAMIN CAP, REGLAN, LASIX, IMODIUM. Patient was hospitalized. Patient recovered.

Oxandrin Side Effects Report #5399926-4
OXANDRIN problem was reported by a Health Professional from UNITED STATES on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: ascites, disease progression, transient ischaemic attack. OXANDRIN dosage: 10MG BID PO. During the same period patient was treated with NIFEREX, ALDACTONE, PHENERGAN, PRILOSEC, VITAMIN CAP, REGLAN, LASIX, IMODIUM. Patient was hospitalized. Patient recovered.

Oxandrin Side Effects Report #5399935-5
Health Professional from UNITED STATES reported OXANDRIN problem on July 26, 2007. Male patient, weighting 119.5 lb, was diagnosed with weight decreased and was treated with OXANDRIN. After drug was administered, patient experienced the following problems/side effects: disease progression. OXANDRIN dosage: 10 MG BID PO. Patient died on 06/09/2007.


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confusional state, delirium, gait disturbance, urinary incontinence, anaemia, ascites, disease progression, gastric cancer, , was diagnosed with weight decreased and was diagnosed with weight decreased and was diagnosed with weight decreased and