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Review Vorinostat Safety Reports submitted to FDA

Total Vorinostat reports: 9.
Vorinostat FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Vorinostat Side Effects: tremor, speech disorder, amnesia, neuropathy peripheral, activities of daily living impaired, vomiting, pleural effusion, oral intake reduced, obstruction gastric, hypokalaemia, fatigue.
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Vorinostat Side Effects Report #5684222-8
Pharmacist from UNITED STATES reported VORINOSTAT problem on Mar 27, 2008. Male patient, weighting 154.3 lb, was diagnosed with t-cell lymphoma and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: neuralgia, somnolence. VORINOSTAT dosage: 300MG QDAY PO. During the same period patient was treated with BORTEZOMIB. Patient was hospitalized. Patient recovered.

Vorinostat Side Effects Report #5591072-X
VORINOSTAT problem was reported by a Pharmacist from UNITED STATES on Jan 11, 2008. Male patient, 55 years of age, was diagnosed with mycosis fungoides and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis. VORINOSTAT dosage: 400MG DAILY PO. Patient was hospitalized. Patient recovered.

Vorinostat Side Effects Report #5621663-9
Health Professional from UNITED STATES reported VORINOSTAT problem on Jan 22, 2008. Male patient, 56 years of age, weighting 150.0 lb, was diagnosed with non-small cell lung cancer, anxiety and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: asthenia, diabetes mellitus inadequate control, disorientation, dysuria, fall, loss of consciousness, malignant neoplasm progression, muscle spasms, muscular weakness. VORINOSTAT dosage: 200 MG/BID/PO. During the same period patient was treated with ERLOTINIB HYDROCHLORIDE, ATIVAN, ALTACE, CENTRUM SILVER, EXCEDRIN, LOMOTIL, ZYRTEC. Patient was hospitalized and became disabled. Patient recovered.

Vorinostat Side Effects Report #5483698-9
VORINOSTAT problem was reported by a Health Professional from UNITED STATES on Sept 26, 2007. Female patient, 18 years of age, weighting 114.0 lb, was diagnosed with acute myeloid leukaemia and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: abdominal pain, caecitis, cellulitis, cheilitis, febrile neutropenia, herpes simplex, oral intake reduced, pyrexia, weight decreased. VORINOSTAT dosage: 400 MG/DAILY/PO CAP. During the same period patient was treated with DECITABINE. Patient was hospitalized. Patient recovered.

Vorinostat Side Effects Report #5505226-1
Health Professional from UNITED STATES reported VORINOSTAT problem on Oct 18, 2007. Male patient, 73 years of age, weighting 209.0 lb, was diagnosed with acute myeloid leukaemia and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. VORINOSTAT dosage: 400 MG/DAILY/PO. During the same period patient was treated with DECITABINE UNK. Patient was hospitalized. Patient recovered.

Vorinostat Side Effects Report #5378067-6
VORINOSTAT problem was reported by a Physician from UNITED STATES on June 22, 2007. Male patient, 55 years of age, weighting 231.0 lb, was diagnosed with multiple myeloma and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, neuropathy peripheral. VORINOSTAT dosage: 400 MG/DAILY/PO. During the same period patient was treated with VELCADE, CENTRUM, FOSAMAX, VALTREX, VITAMIN B CAP. Patient recovered.

Vorinostat Side Effects Report #5378068-8
Physician from UNITED STATES reported VORINOSTAT problem on June 22, 2007. Male patient, 67 years of age, weighting 92.00 lb, was diagnosed with multiple myeloma and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: amnesia, speech disorder, tremor. VORINOSTAT dosage: 400 MG/DAILY/PO. During the same period patient was treated with VELCADE, ACCUPRIL, ADVAIR DISKUS, CARDIZEM, CENTRUM, COUMADIN, LORTAB, LOVENOX. Patient recovered.

Vorinostat Side Effects Report #5378067-6
VORINOSTAT problem was reported by a Physician from UNITED STATES on June 22, 2007. Male patient, 55 years of age, weighting 231.0 lb, was diagnosed with multiple myeloma and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, neuropathy peripheral. VORINOSTAT dosage: 400 MG/DAILY/PO. During the same period patient was treated with VELCADE, CENTRUM, FOSAMAX, VALTREX, VITAMIN B CAP. Patient recovered.

Vorinostat Side Effects Report #5378068-8
Physician from UNITED STATES reported VORINOSTAT problem on June 22, 2007. Male patient, 67 years of age, weighting 92.00 lb, was diagnosed with multiple myeloma and was treated with VORINOSTAT. After drug was administered, patient experienced the following problems/side effects: amnesia, speech disorder, tremor. VORINOSTAT dosage: 400 MG/DAILY/PO. During the same period patient was treated with VELCADE, ACCUPRIL, ADVAIR DISKUS, CARDIZEM, CENTRUM, COUMADIN, LORTAB, LOVENOX. Patient recovered.


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neuralgia, somnolence, diabetic ketoacidosis, asthenia, diabetes mellitus inadequate control, disorientation, dysuria, fall, loss of consciousness, malignant neoplasm progression, muscle spasms, muscular weakness, , was diagnosed with t-cell lymphoma and was diagnosed with mycosis fungoides and was diagnosed with non-small cell lung cancer, anxiety and