Gliadel and post procedural complication Patient Reports February 10, 2010

Gliadel Side Effects Report #5236583-1
Gliadel side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 24, 2007. Female patient, 49 years of age, weighting 125.2 lb, was diagnosed with metastases to central nervous system and was treated with Gliadel. After drug was administered, patient experienced the following side effects: bacterial infection , brain abscess, erythema, extradural abscess, haemoglobin decreased, intracranial hypotension, platelet count increased, post procedural complication, postoperative wound infection. Gliadel dosage: unknown. During the same period patient was treated with TYLENOL, GABAPENTIN, ESZOPICLONE, METHADONE, PAXIL, SENOKOT, TOLTERODINE, LINEZOLID. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5637202-2
Gliadel side effect was reported by a Health Professional from UNITED STATES on Feb 20, 2008. Male patient, 76 years of age, weighting 183.0 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: blood amylase increased, cardio-respiratory arrest, grand mal convulsion, meningitis chemical, post procedural complication, septic shock. Gliadel dosage: 61.6 MG, CEREBRAL IMPLA. Patient died on 02/13/2008.

Gliadel Side Effects Report #4685444-5
Gliadel side effect was reported by a Physician from on May 24, 2005. Female patient, 68 years of age, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, dysphasia, hemiparesis, motor dysfunction, post procedural complication, procedural site reaction, somnolence. Gliadel dosage: unknown. During the same period patient was treated with PHENYTOIN, AMILORIDE, HYDROCHLOROTHIAZIDE, VERAPAMIL, LORAZEPAM, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5261299-5
Gliadel side effect was reported by a Physician from SPAIN on Feb 19, 2007. Female patient, 66 years of age, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: coma, hydrocephalus , post procedural complication. Gliadel dosage: 61.6 MG/X1; ICER. During the same period patient was treated with DEXAMETHASONE, PANTOPRAZOLE, DEPAKENE. Patient was hospitalized. Patient died on 09/16/2005.


Gliadel Side Effects Report #5054299-1
Gliadel side effect was reported by a Physician from UNITED STATES on June 30, 2006. Male patient, 48 years of age, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, cerebral haematoma, deep vein thrombosis , post procedural complication, pulmonary embolism . Gliadel dosage: unknown. During the same period patient was treated with GLIASITE. Patient was hospitalized. Patient died on 05/15/2006.

Gliadel Side Effects Report #5619126-X
Gliadel side effect was reported by a Physician from UNITED STATES on Jan 22, 2008. Male patient, 39 years of age, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: application site discharge, application site inflammation, brain mass, intracranial hypotension, leukocytosis, post procedural complication, purulence, pyrexia, surgical procedure repeated. Gliadel dosage: unknown. During the same period patient was treated with DILANTIN, KEPPRA. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5260978-3
Gliadel side effect was reported by a Physician from SPAIN on Feb 19, 2007. Male patient, 32 years of age, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: hydrocephalus , meningitis aseptic, post procedural complication, recurrent cancer. Gliadel dosage: 61.6 MG;X1;ICER. During the same period patient was treated with TEMOZOLOMIDE, PHENYTOIN, DEXAMETHASONE, PANTOPRAZOLE. Patient was hospitalized. Patient died on 07/31/2005.

Gliadel Side Effects Report #5093838-1
Gliadel side effect was reported by a Health Professional from UNITED STATES on Aug 29, 2006. Female patient, weighting 169.8 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: computerised tomogram abnormal, culture positive, extradural haematoma, headache , incision site complication, lethargy, neurological examination abnormal, post procedural complication, post procedural discharge. Gliadel dosage: 7.7 MG PER WAFER ONCE IV. During the same period patient was treated with LEXAPRO, PROTONIX, CHLORIDE, DECADRON, TYLENOL, ATIVAN, VALPROIC ACID. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5104719-9
Gliadel side effect was reported by a Health Professional from UNITED STATES on Sept 11, 2006. Female patient, weighting 169.8 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: csf test abnormal, extradural haematoma, headache , incision site complication, lethargy, post procedural complication, somnolence, wound infection staphylococcal, wound secretion. Gliadel dosage: 7.7 MG PER WAFER ONCE IV. During the same period patient was treated with LEXAPRO, PROTONIX, CHLORIDE, DECADRON, TYLENOL, ATIVAN, VALPROIC ACID. Patient was hospitalized. Patient recovered.


Gliadel Side Effects Report #4588555-8
Gliadel side effect was reported by a Consumer or non-health professional from on Feb 15, 2005. Female patient, weighting 216.1 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: cerebrospinal fluid leakage, culture positive, incisional drainage, post procedural complication. Gliadel dosage: 7.7 MG PER WAFER - MAX OF 8. During the same period patient was treated with DILANTIN, ASACOL, DECADRON, IMODIUM, PROTONIX. Patient recovered.

Gliadel Side Effects Report #4588555-8
Gliadel side effect was reported by a Consumer or non-health professional from on Feb 15, 2005. Female patient, weighting 216.1 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: cerebrospinal fluid leakage, culture positive, incisional drainage, post procedural complication. Gliadel dosage: 7.7 MG PER WAFER - MAX OF 8. During the same period patient was treated with DILANTIN, ASACOL, DECADRON, IMODIUM, PROTONIX. Patient recovered.

Gliadel Side Effects Report #4725191-4
Gliadel side effect was reported by a Physician from UNITED STATES on July 18, 2005. Male patient, 77 years of age, was diagnosed with glioblastoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: cerebral haematoma, convulsion, depressed level of consciousness, hemiparesis, localised oedema, loss of consciousness, post procedural complication, procedural site reaction. Gliadel dosage: 7.7 MG/WAFER; 8 WAFERS. During the same period patient was treated with AVITENE. Patient recovered.

Gliadel Side Effects Report #5520393-1
Gliadel side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 01, 2007. Female patient, 50 years of age, was diagnosed with glioblastoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, deep vein thrombosis , fatigue, hemiparesis, pneumocephalus, post procedural complication, speech disorder. Gliadel dosage: 61.6 MG; X1; ICER. During the same period patient was treated with KEPPRA, DECADRON. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4725192-6
Gliadel side effect was reported by a Physician from UNITED STATES on July 18, 2005. Male patient, 50 years of age, was diagnosed with astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: arterial haemorrhage, cerebral haemorrhage, cerebral thrombosis, operative haemorrhage, post procedural complication. Gliadel dosage: 7.7MG/WADER; 8 WAFERS. During the same period patient was treated with AVITENE. Patient recovered.


Gliadel Side Effects Report #4847412-X
Gliadel side effect was reported by a Health Professional from UNITED STATES on Nov 22, 2005. Female patient, 49 years of age, was diagnosed with astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: hypertension, post procedural complication, tachycardia, tinnitus . Gliadel dosage: 7.7 MG/WAFER (NUMBER OF WAFERS IMPLANTED NR). Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4847128-X
Gliadel side effect was reported by a Physician from UNITED STATES on Dec 06, 2005. Female patient, 49 years of age, was treated with Gliadel. After drug was administered, patient experienced the following side effects: post procedural complication. Gliadel dosage: unknown. Patient recovered.