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Rilutek Safety Reports submitted to FDA

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Total Rilutek reports: 34.
Rilutek FDA safety alerts: No.
Reported deaths: 21    Reported hospitalizations: 12.
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FDA Reported Rilutek Side Effects: death, alanine aminotransferase increased, disease progression, pneumonia aspiration, pyrexia, aspartate aminotransferase increased, gamma-glutamyltransferase increased, condition aggravated, dysphagia, blood alkaline phosphatase increased, atrial fibrillation.
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Rilutek Side Effects Report #5207170-6
Consumer or non-health professional from reported RILUTEK problem on Nov 13, 2006. Female patient, 70 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, atrial fibrillation, blood alkaline phosphatase increased, pyrexia, urinary tract infection. RILUTEK dosage: unknown. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5208963-1
RILUTEK problem was reported by a Physician from UNITED KINGDOM on Jan 24, 2006. Male patient, 85 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: choking, disease progression, dysphagia. RILUTEK dosage: unknown. Patient was hospitalized. Patient died on 12/30/2005.

Rilutek Side Effects Report #5213219-7
Physician from JAPAN reported RILUTEK problem on Jan 11, 2007. Male patient, 78 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. RILUTEK dosage: unknown. Patient died.

Rilutek Side Effects Report #5220849-5
RILUTEK problem was reported by a Physician from JAPAN on Jan 18, 2007. Male patient, 78 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. RILUTEK dosage: unknown. Patient died.

Rilutek Side Effects Report #5235766-4
Health Professional from JAPAN reported RILUTEK problem on Feb 07, 2007. Male patient, 73 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: injury asphyxiation. RILUTEK dosage: unknown. Patient died on 02/04/2007.

Rilutek Side Effects Report #5264897-8
RILUTEK problem was reported by a Health Professional from JAPAN on Mar 07, 2007. Male patient, 73 years of age, was diagnosed with amyotrophic lateral sclerosis, hypertension and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disease progression. RILUTEK dosage: unknown. During the same period patient was treated with CALSLOT. Patient died on 02/04/2007.

Rilutek Side Effects Report #5267151-3
Physician from JAPAN reported RILUTEK problem on Mar 14, 2007. Female patient, 65 years of age, weighting 100.5 lb, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hepatic function abnormal, interstitial lung disease. RILUTEK dosage: unknown. Patient recovered.

Rilutek Side Effects Report #5273778-5
RILUTEK problem was reported by a Pharmacist from UNITED KINGDOM on Mar 13, 2007. Male patient, 61 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: dysphagia, nasopharyngitis. RILUTEK dosage: unknown. Patient died.

Rilutek Side Effects Report #5286237-0
Consumer or non-health professional from reported RILUTEK problem on Mar 26, 2007. Female patient, 70 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, atrial fibrillation, blood alkaline phosphatase increased, pyrexia. RILUTEK dosage: unknown. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5304393-2
RILUTEK problem was reported by a Health Professional from JAPAN on Apr 18, 2007. Male patient, 79 years of age, was diagnosed with amyotrophic lateral sclerosis, hypertension, rhinitis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: femur fracture. RILUTEK dosage: unknown. During the same period patient was treated with TANATRIL, ALESION, MUCODYNE, PROMAC, HARNAL, ENSURE. Patient recovered.

Rilutek Side Effects Report #5311398-4
Consumer or non-health professional from AUSTRALIA reported RILUTEK problem on Apr 19, 2007. Male patient, 62 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. RILUTEK dosage: unknown. Patient died on 04/13/2007.

Rilutek Side Effects Report #5311399-6
RILUTEK problem was reported by a Consumer or non-health professional from AUSTRALIA on Apr 23, 2007. Male patient, 76 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. RILUTEK dosage: unknown. Patient died on 04/22/2007.

Rilutek Side Effects Report #5329945-5
Consumer or non-health professional from UNITED STATES reported RILUTEK problem on May 17, 2007. Male patient, 75 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: aphagia, dyspnoea. RILUTEK dosage: unknown. Patient was hospitalized. Patient died on 10/22/2006.

Rilutek Side Effects Report #5347717-2
RILUTEK problem was reported by a Health Professional from JAPAN on June 01, 2007. Male patient, 61 years of age, weighting 125.7 lb, was diagnosed with amyotrophic lateral sclerosis, hyperuricaemia, diabetes mellitus and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, pneumonia aspiration. RILUTEK dosage: unknown. During the same period patient was treated with SELOKEN, ALLOPURINOL, GLIMICRON. Patient died on 07/01/2005.

Rilutek Side Effects Report #5044072-2
Health Professional from JAPAN reported RILUTEK problem on May 18, 2006. Male patient, 73 years of age, weighting 143.3 lb, was diagnosed with amyotrophic lateral sclerosis, muscle spasticity and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: disease progression, gastric ulcer haemorrhage, shock haemorrhagic, syncope. RILUTEK dosage: unknown. During the same period patient was treated with MYONAL. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5052502-5
RILUTEK problem was reported by a Health Professional from JAPAN on Aug 09, 2005. Male patient, 76 years of age, was diagnosed with amyotrophic lateral sclerosis, constipation, cerebral infarction, gastric ulcer, anxiety, depression, asthma and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: amyotrophic lateral sclerosis, disease progression, pneumonia, pneumonia aspiration. RILUTEK dosage: unknown. During the same period patient was treated with PURSENNID, SENNOSIDE, CEROCRAL, GASTER, DEPAS, DEPROMEL, NEOPHYLLIN. Patient was hospitalized. Patient died on 03/01/2002.

Rilutek Side Effects Report #5084480-7
Health Professional from JAPAN reported RILUTEK problem on Sept 13, 2005. Male patient, 76 years of age, was diagnosed with amyotrophic lateral sclerosis, constipation and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: ileus, lymphoma, pneumocystis jiroveci pneumonia. RILUTEK dosage: unknown. During the same period patient was treated with PANTOSIN, ALOSENN, MAGNESIUM OXIDE. Patient died on 06/01/2006.

Rilutek Side Effects Report #5084482-0
RILUTEK problem was reported by a Health Professional from CANADA on Aug 01, 2006. Male patient, 60 years of age, was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia. RILUTEK dosage: unknown. Patient died on 08/05/2006.

Rilutek Side Effects Report #5092243-1
Pharmacist from UNITED STATES reported RILUTEK problem on Aug 28, 2006. Male patient, 37 years of age, weighting 195.3 lb, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: asthenia, cough, decreased appetite, dry mouth, dyspnoea, headache, nausea, pyrexia. RILUTEK dosage: 50MG BID PO. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5110164-2
RILUTEK problem was reported by a Pharmacist from CANADA on Sept 08, 2006. Female patient, 42 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: coma, haemorrhage. RILUTEK dosage: unknown. During the same period patient was treated with GRAVOL, ZOPICLONE, DURAGESIC, MORPHINE, MAXERAN, BACLOFEN, LOSEC, SULCRATE PLUS. Patient died on 09/08/2006.

Rilutek Side Effects Report #5123794-9
Pharmacist from JAPAN reported RILUTEK problem on Sept 22, 2006. Male patient, 62 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. RILUTEK dosage: unknown. Patient died on 09/01/2006.

Rilutek Side Effects Report #5143152-0
RILUTEK problem was reported by a Pharmacist from JAPAN on Sept 22, 2006. Male patient, 62 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: disease progression. RILUTEK dosage: unknown. Patient died on 09/01/2006.

Rilutek Side Effects Report #5157359-X
Consumer or non-health professional from reported RILUTEK problem on Nov 13, 2006. Female patient, 70 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, atrial fibrillation, blood alkaline phosphatase increased, hepatic trauma, pyrexia. RILUTEK dosage: unknown. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5159941-2
RILUTEK problem was reported by a Health Professional from JAPAN on Aug 01, 2006. Male patient, 61 years of age, was diagnosed with amyotrophic lateral sclerosis, gastritis, bulbar palsy and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disease progression, pneumonia, pyrexia. RILUTEK dosage: unknown. During the same period patient was treated with FAMOTIDINE, MARZULENE S, AMINO ACIDS. Patient was hospitalized. Patient died on 05/30/2006.

Rilutek Side Effects Report #5190075-7
Physician from DENMARK reported RILUTEK problem on Dec 13, 2006. Female patient, 51 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased. RILUTEK dosage: unknown. During the same period patient was treated with MARCUMAR, VITAMIN K. Patient recovered.

Rilutek Side Effects Report #5392205-0
RILUTEK problem was reported by a Consumer or non-health professional from AUSTRALIA on July 12, 2007. Female patient, 64 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. RILUTEK dosage: unknown. Patient died.

Rilutek Side Effects Report #5397700-6
Physician from AUSTRALIA reported RILUTEK problem on July 20, 2007. Female patient, 64 years of age, was diagnosed with motor neurone disease, depression and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: motor neurone disease. RILUTEK dosage: unknown. During the same period patient was treated with IMIPRAMINE. Patient died.

Rilutek Side Effects Report #5401243-0
RILUTEK problem was reported by a Physician from GERMANY on July 16, 2007. Male patient, weighting 143.3 lb, was diagnosed with progressive supranuclear palsy, cardiovascular event prophylaxis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: dehydration, nausea, pulmonary embolism. RILUTEK dosage: unknown. During the same period patient was treated with ASPIRIN. Patient died.

Rilutek Side Effects Report #5412102-1
Consumer or non-health professional from AUSTRALIA reported RILUTEK problem on Aug 03, 2007. Female patient, 73 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: dysphagia, increased upper airway secretion. RILUTEK dosage: unknown. During the same period patient was treated with ENDEP, AMOXICILLIN. Patient recovered.

Rilutek Side Effects Report #5412106-9
RILUTEK problem was reported by a Health Professional from JAPAN on Aug 08, 2007. Male patient, 63 years of age, was diagnosed with amyotrophic lateral sclerosis, nervous system disorder and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, pneumonia aspiration. RILUTEK dosage: unknown. During the same period patient was treated with JUVELA NICOTINATE, METHYCOBAL, ALLEGRA, VITAMIN B NOS, COMBINATIONS OF VITAMINS, DEPAS. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5412111-2
Physician from JAPAN reported RILUTEK problem on Aug 07, 2007. Female patient, 65 years of age, weighting 100.5 lb, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, interstitial lung disease. RILUTEK dosage: unknown. Patient recovered.

Rilutek Side Effects Report #5412112-4
RILUTEK problem was reported by a Health Professional from JAPAN on Aug 07, 2007. Male patient, 57 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood urea increased, gamma-glutamyltransferase increased, hepatic function abnormal, malaise, myalgia, proteinuria. RILUTEK dosage: unknown. During the same period patient was treated with PL GRAN. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5464462-3
Health Professional from JAPAN reported RILUTEK problem on Sept 18, 2007. Male patient, 57 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood urea increased, gamma-glutamyltransferase increased, liver disorder, malaise, myalgia, proteinuria. RILUTEK dosage: unknown. During the same period patient was treated with PL GRAN. Patient was hospitalized. Patient recovered.

Rilutek Side Effects Report #5465898-7
RILUTEK problem was reported by a Consumer or non-health professional from AUSTRALIA on Sept 14, 2007. Male patient, 79 years of age, was diagnosed with motor neurone disease and was treated with RILUTEK. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. RILUTEK dosage: unknown. Patient died on 06/26/2007.


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alanine aminotransferase increased, atrial fibrillation, blood alkaline phosphatase increased, pyrexia, urinary tract infection, was diagnosed with amyotrophic lateral sclerosis and was diagnosed with motor neurone disease and was diagnosed with amyotrophic lateral sclerosis and