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Zeffix Safety Reports submitted to FDA

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Total Zeffix reports: 29.
Zeffix FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 6.
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FDA Reported Zeffix Side Effects: alanine aminotransferase increased, polymerase chain reaction, leukopenia, splenomegaly, neutropenia, hepatitis b virus, hbv dna increased, joint swelling, arthralgia, dyspnoea exertional, hepatitis b surface antigen positive.
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Zeffix Side Effects Report #5197172-0
Physician from GERMANY reported ZEFFIX problem on Dec 29, 2006. Female patient, child 12 years of age, weighting 103.0 lb, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: hypokalaemia. ZEFFIX dosage: 100MG PER DAY. During the same period patient was treated with DECORTIN, ADALAT, FOLIC ACID, NEXIUM. Patient recovered.

Zeffix Side Effects Report #5198761-X
ZEFFIX problem was reported by a Physician from EGYPT on Jan 03, 2007. Male patient, 24 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia, splenomegaly. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5200096-3
Physician from EGYPT reported ZEFFIX problem on Jan 03, 2007. Male patient, 24 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia, splenomegaly. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5220897-5
ZEFFIX problem was reported by a Consumer or non-health professional from FRANCE on Jan 17, 2007. Female patient, 74 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: coagulopathy, haemorrhage, hepatitis fulminant, hypoalbuminaemia, jaundice, platelet count decreased, prothrombin level decreased, transaminases increased. ZEFFIX dosage: 100MG PER DAY. During the same period patient was treated with PARACETAMOL, HYZAAR, TRIMETAZIDINE, CACIT D, ACTONEL, DOLIPRANE, VIREAD. Patient was hospitalized. Patient died on 10/23/2006.

Zeffix Side Effects Report #5233709-0
Physician from EGYPT reported ZEFFIX problem on Jan 31, 2007. Male patient, 41 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, polymerase chain reaction. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5249857-5
ZEFFIX problem was reported by a Pharmacist from UNITED KINGDOM on Feb 26, 2007. Male patient was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: non-hodgkin's lymphoma. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5255334-8
Consumer or non-health professional from ITALY reported ZEFFIX problem on Mar 01, 2007. Female patient, 50 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. ZEFFIX dosage: 100MG PER DAY. During the same period patient was treated with HEPSERA. Patient recovered.

Zeffix Side Effects Report #5267287-7
ZEFFIX problem was reported by a Physician from EGYPT on Mar 05, 2007. Male patient, 41 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, polymerase chain reaction. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5272788-1
Consumer or non-health professional from GERMANY reported ZEFFIX problem on Mar 21, 2007. Male patient, 67 years of age, weighting 165.3 lb, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: hepatic failure, lactic acidosis. ZEFFIX dosage: 100MG PER DAY. Patient was hospitalized. Patient died on 03/09/2007.

Zeffix Side Effects Report #5293525-0
ZEFFIX problem was reported by a Physician from KOREA, REPUBLIC OF on Apr 03, 2007. Male patient, 45 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: facial palsy, hypertonia, hypotonia, neck pain, viral hepatitis carrier. ZEFFIX dosage: unknown. During the same period patient was treated with HEPSERA. Patient recovered.

Zeffix Side Effects Report #5296194-9
Physician from EGYPT reported ZEFFIX problem on Apr 12, 2007. Male patient, 41 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, hbv-dna polymerase increased, hepatitis b surface antigen positive, polymerase chain reaction. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5297940-0
ZEFFIX problem was reported by a Physician from KOREA, REPUBLIC OF on Apr 12, 2007. Male patient, 45 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: facial palsy, hypertonia, neck pain, viral hepatitis carrier. ZEFFIX dosage: unknown. During the same period patient was treated with HEPSERA. Patient recovered.

Zeffix Side Effects Report #5085611-5
Physician from FRANCE reported ZEFFIX problem on Aug 16, 2006. Female patient, 28 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: ovarian failure. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5096011-6
ZEFFIX problem was reported by a Consumer or non-health professional from FRANCE on Aug 24, 2006. Male patient, 59 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, anorexia, asthenia, blood creatine increased, blood potassium increased, c-reactive protein increased, dehydration, dialysis. ZEFFIX dosage: 100MG PER DAY. Patient was hospitalized. Patient recovered.

Zeffix Side Effects Report #5096031-1
Health Professional from GERMANY reported ZEFFIX problem on Aug 31, 2006. Male patient, 48 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: cardiovascular disorder, circulatory collapse, fall. ZEFFIX dosage: unknown. Patient died on 08/31/2006.

Zeffix Side Effects Report #5112690-9
ZEFFIX problem was reported by a Consumer or non-health professional from FRANCE on Feb 17, 2005. Male patient, 52 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anuria, ascites, atrial fibrillation, bone marrow failure, dizziness postural, dyspnoea exertional, hepatocellular damage, inflammation. ZEFFIX dosage: 100MG PER DAY. During the same period patient was treated with ISKEDYL, VASTAREL, BISOPROLOL FUMARATE, FOZITEC, ATACAND, ATEPADENE, NOOTROPYL, TANAKAN. Patient was hospitalized. Patient died on 05/09/2005.

Zeffix Side Effects Report #5123873-6
Consumer or non-health professional from SWITZERLAND reported ZEFFIX problem on Oct 05, 2006. Male patient, 51 years of age, weighting 163.1 lb, was diagnosed with nephritic syndrome, portal hypertension and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: breath sounds abnormal, bronchial obstruction, cough, dyspnoea, obstructive airways disorder, prolonged expiration, rhonchi. ZEFFIX dosage: unknown. During the same period patient was treated with ZESTRIL, INDERAL. Patient recovered.

Zeffix Side Effects Report #5146066-5
ZEFFIX problem was reported by a Physician from GERMANY on Nov 07, 2006. Female patient, child 12 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: hypokalaemia. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5146890-9
Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA reported ZEFFIX problem on Nov 02, 2006. Female patient, 35 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: arthralgia, joint swelling. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5152195-2
ZEFFIX problem was reported by a Consumer or non-health professional from ISRAEL on Nov 07, 2006. Female patient was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: hbv dna increased, hepatitis, hepatitis b virus. ZEFFIX dosage: 3MGK PER DAY. Patient recovered.

Zeffix Side Effects Report #5154022-6
Consumer or non-health professional from ISRAEL reported ZEFFIX problem on Nov 07, 2006. Female patient was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: hbv dna increased, hepatitis, hepatitis b virus. ZEFFIX dosage: 3MGK PER DAY. Patient recovered.

Zeffix Side Effects Report #5157554-X
ZEFFIX problem was reported by a Physician from EGYPT on Nov 18, 2006. Male patient, 24 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: leukopenia. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5164753-X
Physician from TAIWAN, PROVINCE OF CHINA reported ZEFFIX problem on Nov 02, 2006. Female patient, 35 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthritis, joint swelling, local swelling. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5165594-X
ZEFFIX problem was reported by a Physician from EGYPT on Nov 29, 2006. Male patient, 24 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia, splenomegaly. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5188273-1
Consumer or non-health professional from FRANCE reported ZEFFIX problem on Dec 12, 2006. Female patient, 50 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: nephropathy toxic, renal failure chronic, renal transplant, surgical procedure repeated. ZEFFIX dosage: unknown. During the same period patient was treated with HEPSERA, NEORAL, EPREX, FUROSEMIDE INTENSOL, SECTRAL, MEDIATENSYL, NOCTRAN, RENAGEL. Patient was hospitalized. Patient recovered.

Zeffix Side Effects Report #5190516-5
ZEFFIX problem was reported by a Physician from EGYPT on Dec 18, 2006. Male patient, 41 years of age, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, polymerase chain reaction. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5393884-4
Consumer or non-health professional from KOREA, REPUBLIC OF reported ZEFFIX problem on July 16, 2007. Male patient, 50 years of age, was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: arthropathy, rhabdomyolysis. ZEFFIX dosage: unknown. Patient recovered.

Zeffix Side Effects Report #5400449-4
ZEFFIX problem was reported by a Physician from GERMANY on July 18, 2007. Female patient, 19 years of age, weighting 132.3 lb, was diagnosed with hepatitis b and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: premature labour. ZEFFIX dosage: 100MG PER DAY. Patient recovered.

Zeffix Side Effects Report #5412538-9
Consumer or non-health professional from FRANCE reported ZEFFIX problem on Aug 08, 2007. Male patient, 56 years of age, weighting 110.2 lb, was diagnosed with viral infection and was treated with ZEFFIX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, anaemia, cholelithiasis, leukocytosis, liver disorder, oedematous pancreatitis, pancreatic necrosis, pancreatitis acute. ZEFFIX dosage: 100MG PER DAY. During the same period patient was treated with CLAFORAN, KALETRA, TELZIR, ACTRAPID, TRIATEC, LASIX, TENORMIN, EUPRESSYL. Patient was hospitalized. Patient recovered.

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