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Review Oramorph Safety Reports submitted to FDA

Total Oramorph reports: 7.
Oramorph FDA safety alerts: No.
Reported deaths: 3    .
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FDA Reported Oramorph Side Effects: respiratory arrest, cardiac arrest, confusional state, overdose, accidental overdose, completed suicide, death, swollen tongue, dyspnoea, memory impairment, hallucination.
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Oramorph Side Effects Report #5642566-X
Physician from UNITED STATES reported ORAMORPH problem on Feb 27, 2008. Female patient, 60 years of age, was diagnosed with myofascial pain syndrome and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hallucination, palpitations, stomach discomfort. ORAMORPH dosage: SR 100MG ONE QD #30 (ORAL). During the same period patient was treated with METHADONE. Patient recovered.

Oramorph Side Effects Report #5408884-5
ORAMORPH problem was reported by a Consumer or non-health professional from on Aug 07, 2007. Male patient, 24 years of age, was diagnosed with trigeminal neuralgia and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: hypertensive crisis. ORAMORPH dosage: unknown. During the same period patient was treated with VICODIN, DILAUDID, DEMEROL. Patient recovered.

Oramorph Side Effects Report #5408886-9
Pharmacist from UNITED KINGDOM reported ORAMORPH problem on Aug 06, 2007. Male patient, 84 years of age, was diagnosed with carcinoid tumour of the stomach and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: accidental overdose. ORAMORPH dosage: 100 MG/5 ML. Patient died.

Oramorph Side Effects Report #5384612-7
ORAMORPH problem was reported by a Pharmacist from UNITED KINGDOM on July 09, 2007. Male patient, 84 years of age, was diagnosed with analgesia and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: accidental overdose. ORAMORPH dosage: 100 MG/5 ML. Patient died.

Oramorph Side Effects Report #5400944-8
Physician from reported ORAMORPH problem on July 27, 2007. Female patient, 59 years of age, was diagnosed with pain, cholecystitis, hypertension, haemoglobin decreased, thyroid disorder and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: dyspnoea, swollen tongue. ORAMORPH dosage: unknown. During the same period patient was treated with CIPROFLOXACIN, GENTAMICIN, LOSARTAN POTASSIUM, FERROUS SULPHATE, LEVOTHYROXINE. Patient recovered.

Oramorph Side Effects Report #5384612-7
ORAMORPH problem was reported by a Pharmacist from UNITED KINGDOM on July 09, 2007. Male patient, 84 years of age, was diagnosed with analgesia and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: accidental overdose. ORAMORPH dosage: 100 MG/5 ML. Patient died.

Oramorph Side Effects Report #5400944-8
Physician from reported ORAMORPH problem on July 27, 2007. Female patient, 59 years of age, was diagnosed with pain, cholecystitis, hypertension, haemoglobin decreased, thyroid disorder and was treated with ORAMORPH. After drug was administered, patient experienced the following problems/side effects: dyspnoea, swollen tongue. ORAMORPH dosage: unknown. During the same period patient was treated with CIPROFLOXACIN, GENTAMICIN, LOSARTAN POTASSIUM, FERROUS SULPHATE, LEVOTHYROXINE. Patient recovered.


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dyspnoea, hallucination, palpitations, stomach discomfort, hypertensive crisis, accidental overdose, , was diagnosed with myofascial pain syndrome and was diagnosed with trigeminal neuralgia and was diagnosed with carcinoid tumour of the stomach and