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Review Vianite Safety Reports submitted to FDA

Total Vianite reports: 7.
Vianite FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 4.
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FDA Reported Vianite Side Effects: asthma, obstruction, fatigue, exercise tolerance decreased, dyspnoea, cough, breast pain, speech disorder, increased upper airway secretion, dysphonia, chest discomfort.
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Vianite Side Effects Report #5664519-8
Consumer or non-health professional from GERMANY reported VIANITE problem on Mar 07, 2008. Female patient, 23 years of age, was diagnosed with asthma and was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: asthma, bronchitis, condition aggravated, dyspnoea, infection, lung disorder, swelling face. VIANITE dosage: unknown. During the same period patient was treated with SULTANOL, NOVOPULMON, CICLESONIDE, DILTIAZEM, SINGULAIR, OMEPRAZOLE, PROCORALAN. Patient was hospitalized. Patient recovered.

Vianite Side Effects Report #5614195-5
VIANITE problem was reported by a Health Professional from GERMANY on Feb 01, 2008. Female patient, 64 years of age, was diagnosed with respiratory failure, tachycardia, alveolitis, hypertension and was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: blister, chronic myeloid leukaemia, conjunctivitis, genital erosion, hyperuricaemia, lip erosion, nikolsky's sign, oral herpes, oral mucosa erosion. VIANITE dosage: unknown. During the same period patient was treated with SPIRIVA, SALMETEROL, DILTIAZEM RETARD, PREDNISOLONE, TORSEMIDE, SEREVENT, ALBUTEROL, CALCIUM GLUCONATE. Patient was hospitalized. Patient died on 03/11/2005.

Vianite Side Effects Report #5645361-0
Physician from GERMANY reported VIANITE problem on Feb 26, 2008. Female patient, 75 years of age, weighting 165.3 lb, was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, infective exacerbation of chronic obstructive airways disease. VIANITE dosage: unknown. During the same period patient was treated with THEOPHYLLINE, SPIRIVA, BERODUAL, OXYGEN, CIPROFLOXACIN HYDROCHLORIDE, PREDNISOLONE. Patient was hospitalized. Patient died on 11/24/2007.

Vianite Side Effects Report #5593332-5
VIANITE problem was reported by a Consumer or non-health professional from GERMANY on Jan 09, 2008. Female patient, 23 years of age, was diagnosed with asthma and was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: asthma, bronchitis, lung disorder. VIANITE dosage: unknown. During the same period patient was treated with NOVOPULMON, CICLESONIDE, DILTIAZEM, SINGULAIR, OMEPRAZOLE, PROCORALAN. Patient was hospitalized. Patient recovered.


Vianite Side Effects Report #5442004-6
Consumer or non-health professional from GERMANY reported VIANITE problem on Aug 30, 2007. Female patient was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: asthma, chest discomfort, dysphonia, increased upper airway secretion, speech disorder. VIANITE dosage: unknown. During the same period patient was treated with SINGULAIR, BERODUAL, XOLAIR. Patient recovered.

Vianite Side Effects Report #5451442-7
VIANITE problem was reported by a Consumer or non-health professional from GERMANY on Sept 12, 2007. Female patient, 32 years of age, was diagnosed with asthma and was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: asthma, breast pain, cough, dyspnoea, exercise tolerance decreased, fatigue, obstruction. VIANITE dosage: unknown. During the same period patient was treated with SINGULAIR, SULTANOL, BERODUAL. Patient recovered.

Vianite Side Effects Report #5709661-8
Consumer or non-health professional from GERMANY reported VIANITE problem on Apr 15, 2008. Female patient, 27 years of age, was diagnosed with asthma and was treated with VIANITE. After drug was administered, patient experienced the following problems/side effects: asthma, fluid retention, joint swelling, micturition urgency, oedema peripheral, pollakiuria, rash. VIANITE dosage: unknown. During the same period patient was treated with FLUTIDETE, AERIUS, SINGULAIR. Patient recovered.


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