Alpha Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Alpha reports: 8.
Alpha FDA safety alerts: 2001 2002 2003 2004 2005 2006 2007 2008 .
Reported deaths: 1 Reported hospitalizations: 13.
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FDA Reported Alpha Side Effects: pruritus, weight increased, tachycardia, rash maculo-papular, infusion related reaction, face oedema, viral upper respiratory tract infection, skin discolouration, depressed level of consciousness, cardiac disorder, heart disease congenital.
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Alpha Side Effects Report #5270532-5
Physician from UNITED STATES reported ALPHA problem on Mar 01, 2007. Female patient, 46 years of age, weighting 160.7 lb, was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: contusion, dry skin, eczema, gangrene, oedema peripheral, pain in extremity, pitting oedema, pruritus, pseudomonas infection. ALPHA dosage: 20 MG/KG Q2WKS IV. Patient recovered.
Alpha Side Effects Report #5355098-3
ALPHA problem was reported by a Physician from FRANCE on June 05, 2007. Male patient, 43 years of age, weighting 158.7 lb, was diagnosed with nasopharyngitis and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, c-reactive protein increased, epigastric discomfort, lipase increased, pancreatitis acute, serum ferritin increased, white blood cell count increased. ALPHA dosage: unknown. During the same period patient was treated with PIVALONE, VOLTAREN. Patient was hospitalized. Patient recovered.
Alpha Side Effects Report #5081930-7
Physician from KOREA, REPUBLIC OF reported ALPHA problem on July 28, 2006. Female patient, 29 years of age, weighting 74.96 lb, was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: face oedema, gastric ulcer, infusion related reaction, pruritus, rash maculo-papular, tachycardia. ALPHA dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with RANITIDINE. Patient recovered.
Alpha Side Effects Report #5091362-3
ALPHA problem was reported by a Physician from KOREA, REPUBLIC OF on Aug 10, 2006. Female patient, 29 years of age, weighting 74.96 lb, was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: body temperature increased, dyspnoea, face oedema, flushing, infusion related reaction, pruritus, rash maculo-papular, tachycardia. ALPHA dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with RANITIDINE, TAZOBACTAM, ISEPAMICIN. Patient recovered.
Alpha Side Effects Report #5122592-X
Consumer or non-health professional from GREECE reported ALPHA problem on Sept 20, 2006. Female patient was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated, upper respiratory tract infection, weight increased. ALPHA dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with DIURETICS. Patient was hospitalized. Patient recovered.
Alpha Side Effects Report #5205590-7
ALPHA problem was reported by a Physician from UNITED STATES on July 12, 2006. Male patient, 16 years of age, was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: dizziness, headache, nausea, syncope. ALPHA dosage: 20 MG/KG Q2WKS; IV. During the same period patient was treated with PINDOLOL, ENALAPRIL MALEATE. Patient recovered.
Alpha Side Effects Report #5143070-8
Consumer or non-health professional from UNITED STATES reported ALPHA problem on Nov 01, 2006. Female patient, weighting 5.00 lb, was diagnosed with premature baby and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: heart disease congenital. ALPHA dosage: 250 MG WEEKLY IM. Patient died on 05/02/2006.
Alpha Side Effects Report #5162052-3
ALPHA problem was reported by a Physician from GREECE on Nov 09, 2006. Female patient was diagnosed with glycogen storage disease type ii and was treated with ALPHA. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, depressed level of consciousness, skin discolouration, viral upper respiratory tract infection, weight increased. ALPHA dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with DIURETICS. Patient was hospitalized. Patient recovered.
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