Like all medicines, GLIADEL Implants can cause side effects, although not everybody gets them.
If you experience any of the following side effects as a new event, or if a side effect that you have worsens, tell your doctor immediately or go to the casualty department at your nearest hospital.
The most common adverse events observed during trials in either newly-diagnosed malignant glioma (brain tumour) (120 patients) or recurrent diagnosed malignant glioma (110 patients) are presented below.
The following four categories of side effects are possibly related to treatment with GLIADEL Implants.
1. Seizures were very common. Most of them had a mild to moderate intensity and occurred within 5 days of the surgical treatment.
2. Brain swelling was very common. The development of brain swelling could necessitate a new surgical intervention either to remove the implants or the remnants of the implants.
3. Mild to severe wound healing problems were very common.
4. Infections in the brain (infections within the skull) such as meningitis and abscess(es) (localised collections of pus) were common.
The following side effects were seen in the patients during the trials. They were similar to those encountered by patients who have surgery for their brain cancer without the insertion of GLIADEL Implants.
Very common: may affect more than 1 in 10 people
Depression
Weakness, especially on one side of the body; convulsion (fits); confusion; headache; swelling of the brain; somnolence (drowsiness); problems with speech
Vein inflammation
- Gastrointestinal disorders (stomach and intestinal related disorders)
Nausea (feeling sick); vomiting; constipation
- Skin and subcutaneous (tissue under the skin) disorders
Rash; hair loss
- Renal (kidney) and urinary disorders
Infection of the urinary tract
- General disorders and administration site conditions
A worsening of your condition; infection; headache; feeling of weakness; fever or pain; abnormal (slow) healing of the surgical wound
Common: may affect up to 1 in 10 people
- Blood and lymphatic (immune) system disorders
Reduction in red blood cells which can make the skin pale and cause weakness and breathlessness; reduction in blood platelets which increases the risk of bleeding; increase in white blood cells
- Endocrine disorders (hormonal disorders)
Diabetes mellitus (abnormally high sugar level in blood)
- Metabolism & nutrition disorders
Peripheral oedema (excess fluid in the arms and legs); low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma; high blood sugar levels; low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
Changes in your personality; excessive anxiety; abnormal thinking; hallucinations; insomnia (little or poor sleep)
Amnesia (loss of memory); an increase in the blood pressure in the skull due to abnormal build up of fluid; paralysis of the face; lack of coordination; diminished sensitivity to stimulation; abnormal burning or prickling sensation; problems with walking; dizziness; epileptic seizures (fits); tremor (small shaking movements); meningitis (inflammation of the brain); abscess (localised collection of pus); loss of consciousness
Blurred or abnormal vision; swelling of the eye lining; eye pain
Vascular disorders
Bleeding; high or low blood pressure
- Respiratory disorders (Lung related disorders)
Lung infection or pneumonia which causes breathlessness, cough and raised temperature
- Gastrointestinal disorders (Stomach and intestinal related disorders)
Yeast infection of the mouth; diarrhoea; constipation; faecal incontinence (uncontrolled bowel movements); difficulty in swallowing; bleeding in the stomach or in bowels.
- Skin and subcutaneous (tissue under the skin) disorders
Rash
- Muscle, skeletal and soft tissue related disorders
General infection
- Renal (kidney) and urinary disorders
Urinary infections ; urinary incontinence
- General disorders and administration site conditions
Abdominal, back and chest pain; swelling of the face; abscess (localised collection of pus); accidental injury; allergic reaction; neck pain and infection in the blood stream.
Uncommon side effects (between 1 and 10 patients in every 1000)
Injury, poisoning and procedural complications
Pneumocephalus (air accumulation at the implant site)
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.