Gliadel and brain oedema Patient Reports February 11, 2012

Gliadel Side Effects Report #5982934-X
Gliadel side effect was reported by a Health Professional from UNITED STATES on July 10, 2008. Female patient was diagnosed with malignant glioma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, cerebral cyst, convulsion, deep vein thrombosis , impaired healing, implant site reaction, intracranial hypotension, meningitis . Gliadel dosage: unknown. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5380024-0
Gliadel side effect was reported by a Physician from UNITED KINGDOM on June 19, 2007. Male patient, 36 years of age, weighting 238.1 lb, was diagnosed with gliosarcoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain neoplasm malignant, brain oedema, gliosarcoma, headache , hemiparesis, inflammation, intracranial pressure increased, malignant neoplasm progression, somnolence. Gliadel dosage: 61.6 MG;X1; ICER. During the same period patient was treated with DEXAMETHASONE, PHENYTOIN, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4945318-9
Gliadel side effect was reported by a Pharmacist from UNITED STATES on Mar 15, 2006. Male patient, 52 years of age, was diagnosed with glioma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, headache . Gliadel dosage: unknown. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4772869-2
Gliadel side effect was reported by a Physician from SOUTH AFRICA on Sept 05, 2005. Female patient, 39 years of age, weighting 125.7 lb, was diagnosed with glioma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, coma. Gliadel dosage: 8 WAFER; 7.7 MG/WAFER. During the same period patient was treated with TEMOXOL, DECADRON, TRILEPTAL. Patient died on 09/02/2005.


Gliadel Side Effects Report #4983044-0
Gliadel side effect was reported by a Physician from UNITED KINGDOM on Apr 05, 2006. Female patient, 26 years of age, was diagnosed with glioma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain herniation, brain oedema, cerebral infarction. Gliadel dosage: 38.5 MG; X1; ICER. During the same period patient was treated with DEXAMETHASONE. Patient was hospitalized. Patient died on 03/17/2006.

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 #4852558-6
Gliadel side effect was reported by a Physician from SPAIN 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, brain scan abnormal, dysphasia, encephalopathy, hemiparesis, pneumocephalus. 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 #4580263-2
Gliadel side effect was reported by a Physician from on Apr 26, 2004. Male 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: brain oedema, coma, decerebration, mydriasis, pupil fixed, pupillary light reflex tests abnormal, pupils unequal, subdural haematoma. Gliadel dosage: unknown. During the same period patient was treated with GENTAMICIN SULPHATE, DEXAMETHASONE, PHENYTOIN CAP, FAMOTIDINE. Patient died on 04/24/2004.

Gliadel Side Effects Report #5526713-6
Gliadel side effect was reported by a Health Professional from UNITED STATES on Feb 14, 2007. Female patient, 58 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: brain oedema, hemiparesis. Gliadel dosage: 61.6 MG;X1;ICER. During the same period patient was treated with PEPCID, DECADRON, KEPPRA, VITAMIN D3, SINEMET, VITAMIN CAP. Patient was hospitalized. Patient recovered.


Gliadel Side Effects Report #5526658-1
Gliadel side effect was reported by a Physician from UNITED STATES on July 19, 2007. Male patient, 55 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, implant site necrosis, neurological symptom. Gliadel dosage: 61.6 MG;1X;ICER. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5264617-7
Gliadel side effect was reported by a Physician from SPAIN on Feb 14, 2006. Female patient, 54 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, disease progression. Gliadel dosage: 61.6 MG;X1;ICERE. Patient was hospitalized. Patient died on 02/21/2006.

Gliadel Side Effects Report #5265081-4
Gliadel side effect was reported by a Health Professional from FRANCE on Dec 01, 2005. Female patient, 51 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, incision site infection. Gliadel dosage: 46.2 MG;X1;ICER. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4852561-6
Gliadel side effect was reported by a Physician from UNITED STATES on Aug 01, 2005. Male patient, 50 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, fall . Gliadel dosage: 7.7 MG/WAFER; 5 1/2 WAFERS. During the same period patient was treated with COUMADIN, DILANTIN, TEMOZOLOMIDE, DEXAMETHASONE, ACTOS. Patient was hospitalized. Patient recovered.

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 #5752990-2
Gliadel side effect was reported by a Physician from SPAIN on May 14, 2008. Male patient, 41 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, neurological symptom, treatment failure. Gliadel dosage: 61.6 MG,1X;ICER. During the same period patient was treated with TEMOZOLOMIDE. Patient was hospitalized. Patient died on 05/31/2008.

Gliadel Side Effects Report #5241324-8
Gliadel side effect was reported by a Health Professional from UNITED STATES on Feb 15, 2007. Female patient, weighting 183.0 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, computerised tomogram abnormal, hemiparesis, muscular weakness, neuropathy. Gliadel dosage: 7.7 MG PER WAFER ONCE IV. During the same period patient was treated with PEPCID, DECADRON, KEPPRA, VITAMIN D3, SINEMET. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5512725-5
Gliadel side effect was reported by a Consumer or non-health professional from UNITED STATES on June 27, 2007. Female patient was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, confusional state, encephalitis , glioblastoma multiforme, malignant neoplasm progression, psychotic disorder . Gliadel dosage: unknown. During the same period patient was treated with TEMOZOLOMIDE. Patient recovered.

Gliadel Side Effects Report #5982908-9
Gliadel side effect was reported by a Consumer or non-health professional from UNITED STATES on June 27, 2007. Female patient was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, disease progression, encephalitis , implant site necrosis, postoperative wound infection, psychotic disorder . Gliadel dosage: unknown. During the same period patient was treated with TEMOZOLOMIDE. Patient died.

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 #5701521-1
Gliadel side effect was reported by a Physician from FRANCE on Nov 25, 2007. Female patient, 43 years of age, weighting 136.7 lb, was diagnosed with glioblastoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, cerebral ischaemia, coma, decubitus ulcer, post procedural oedema. Gliadel dosage: 61.6 MG; X1; ICER. Patient died on 09/09/2007.

Gliadel Side Effects Report #5711792-3
Gliadel side effect was reported by a Physician from FRANCE on Nov 25, 2007. Female patient, 43 years of age, weighting 136.7 lb, was diagnosed with glioblastoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, cerebral ischaemia, coma, decubitus ulcer, intracranial pressure increased, ischaemic stroke, mydriasis. Gliadel dosage: 61.6 MG; X1; ICER. Patient died on 09/09/2007.

Gliadel Side Effects Report #4602930-4
Gliadel side effect was reported by a Physician from on Feb 16, 2005. Female patient, 39 years of age, was diagnosed with astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, implant site oedema, pupil fixed, wound secretion. Gliadel dosage: unknown. Patient recovered.

Gliadel Side Effects Report #4596547-8
Gliadel side effect was reported by a Health Professional from on Feb 11, 2005. Male patient, 60 years of age, weighting 220.5 lb, was diagnosed with anaplastic astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, medical device removal, necrosis, radiation injury. Gliadel dosage: 61.6 MG (7.7 MG, 8 IN 1 ONCE), IMPLANT. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #4852557-4
Gliadel side effect was reported by a Physician from SPAIN on Apr 26, 2005. Female patient, 55 years of age, was diagnosed with anaplastic astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, pleural effusion, urinary tract infection . Gliadel dosage: unknown. During the same period patient was treated with DEXAMETHASONE, DIAZEPAM, VALPROATE, PHENOBARBITAL, TEMOZOLOMIDE. Patient was hospitalized. Patient recovered.


Gliadel Side Effects Report #5982834-5
Gliadel side effect was reported by a Physician from UNITED STATES on Mar 12, 2008. Male patient, 38 years of age, was diagnosed with anaplastic astrocytoma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, meningitis , off label use. Gliadel dosage: unknown. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5982909-0
Gliadel side effect was reported by a Physician from UNITED STATES on Sept 27, 2007. Female patient was diagnosed with anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, oligodendroglioma and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, convulsion, wound infection. Gliadel dosage: unknown. Patient recovered.

Gliadel Side Effects Report #5264633-5
Gliadel side effect was reported by a Physician from SPAIN on Mar 23, 2006. Female patient, 66 years of age, was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, coma. Gliadel dosage: unknown. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5409534-4
Gliadel side effect was reported by a Health Professional from UNITED STATES on Aug 08, 2007. Female patient, weighting 183.0 lb, was diagnosed with glioblastoma multiforme and was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, hemiparesis. Gliadel dosage: 7.7 MG PER WAFER ONCE IV. During the same period patient was treated with PEPCID, DECADRON, KEPPRA, VITAMIN D3, SINEMET. Patient was hospitalized. Patient recovered.

Gliadel Side Effects Report #5009181-2
Gliadel side effect was reported by a Physician from UNITED KINGDOM on May 05, 2006. Female patient was treated with Gliadel. After drug was administered, patient experienced the following side effects: brain oedema, status epilepticus. Gliadel dosage: unknown. Patient was hospitalized. Patient recovered.