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Review Gefitinib Safety Reports submitted to FDA

Total Gefitinib reports: 8.
Gefitinib FDA safety alerts: 2005 .
Reported deaths: 2    Reported hospitalizations: 3.
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FDA Reported Gefitinib Side Effects: pulmonary fibrosis, interstitial lung disease, transaminases increased, thrombocytopenia, somnolence, prescribed overdose, orthostatic hypotension, metastases to central nervous system, renal failure acute, pneumonia aspiration, nephropathy toxic.
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Gefitinib Side Effects Report #5622193-0
Physician from UNITED KINGDOM reported GEFITINIB problem on Feb 07, 2008. Male patient, weighting 136.7 lb, was diagnosed with non-small cell lung cancer, metastases to liver, pain, angina pectoris, dyspepsia, infection, haemoglobin decreased and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, neutropenic sepsis. GEFITINIB dosage: unknown. During the same period patient was treated with DICLOFENAC, ATENOLOL, FUROSEMIDE, LANSOPRAZOLE, AMOXICILLIN, FERROUS SULPHATE, ASPIRIN. Patient was hospitalized and became disabled. Patient recovered.

Gefitinib Side Effects Report #5585422-8
GEFITINIB problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Male patient, 72 years of age, was diagnosed with lung adenocarcinoma stage iv and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: myelodysplastic syndrome. GEFITINIB dosage: unknown. During the same period patient was treated with GEMCITABINE, CARBOPLATIN. Patient recovered.

Gefitinib Side Effects Report #5601460-0
Health Professional from TAIWAN, PROVINCE OF CHINA reported GEFITINIB problem on Jan 21, 2008. Female patient, 69 years of age, was diagnosed with lung neoplasm malignant and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: dermatosis. GEFITINIB dosage: unknown. Patient recovered.

Gefitinib Side Effects Report #5746747-6
GEFITINIB problem was reported by a Health Professional from FRANCE on May 20, 2008. Female patient, 50 years of age, was diagnosed with lung neoplasm malignant and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: propionibacterium infection. GEFITINIB dosage: unknown. Patient was hospitalized. Patient recovered.


Gefitinib Side Effects Report #5750891-7
Health Professional from TAIWAN, PROVINCE OF CHINA reported GEFITINIB problem on May 20, 2008. Male patient, 57 years of age, was diagnosed with lung neoplasm malignant, adenocarcinoma, metastases to central nervous system and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: radiation skin injury, subdural haematoma. GEFITINIB dosage: unknown. During the same period patient was treated with ERLOTINIB. Patient recovered.

Gefitinib Side Effects Report #5753799-6
GEFITINIB problem was reported by a Health Professional from FRANCE on May 28, 2008. Female patient, 50 years of age, was diagnosed with lung adenocarcinoma and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: propionibacterium infection. GEFITINIB dosage: unknown. Patient was hospitalized. Patient recovered.

Gefitinib Side Effects Report #5267547-X
Consumer or non-health professional from UNITED STATES reported GEFITINIB problem on Apr 25, 2005. Male patient, 55 years of age, was diagnosed with non-small cell lung cancer and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. GEFITINIB dosage: 250 MG DAILY PO. During the same period patient was treated with CARBOPLATIN, PACLITAXEL, DOCETAXEL. Patient died.

Gefitinib Side Effects Report #5267862-X
GEFITINIB problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 25, 2005. Male patient, 59 years of age, was diagnosed with non-small cell lung cancer and was treated with GEFITINIB. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. GEFITINIB dosage: 250 MG DAILY PO. During the same period patient was treated with CARBOPLATIN, PACLITAXEL, DOCETAXEL. Patient died.


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myocardial infarction, neutropenic sepsis, myelodysplastic syndrome, dermatosis, propionibacterium infection, , %drugN% was diagnosed with non-small cell lung cancer, metastases to liver, pain, angina pectoris, dyspepsia, infection, haemoglobin decreased and