ADVERSE REACTIONS
In controlled and open label clinical studies, 560 patients with chronic malignant or non-malignant pain were treated with AVINZA. The most common serious adverse events reported with administration of AVINZA were vomiting, nausea, death, dehydration, dyspnea, and sepsis. (Deaths occurred in patients treated for pain due to underlying malignancy.) Serious adverse events caused by morphine include respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
Adverse Events
The common adverse events seen on initiation of therapy with morphine are dose-dependent and are typical opioid‑related side effects. The most frequent of these include constipation, nausea and somnolence. The frequency of these events depends upon several factors including the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. These events should be anticipated and managed as part of opioid analgesia therapy.
The most common adverse events (seen in greater than 10%) reported by patients treated with AVINZA during the clinical trials at least once during therapy were constipation, nausea, somnolence, vomiting, and headache. Adverse events occurring in 5‑10% of study patients were peripheral edema, diarrhea, abdominal pain, infection, urinary tract infection, accidental injury, flu syndrome, back pain, rash, sweating, fever, insomnia, depression, paresthesia, anorexia, dry mouth, asthenia and dyspnea. Other less common side effects expected from opioid analgesics, including morphine, or seen in fewer than 5% of patients taking AVINZA in the clinical trials were:
Body as a Whole: malaise, withdrawal syndrome.
Cardiovascular System: bradycardia, hypertension, hypotension, palpitations, syncope, tachycardia.
Digestive System: biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectal disorder, thirst.
Hemic and Lymphatic System: anemia, thrombocytopenia.
Metabolic and Nutritional Disorders: edema, weight loss.
Musculoskeletal: skeletal muscle rigidity.
Nervous System: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo .
Respiratory System: hiccup, hypoventilation, voice alteration.
Skin and Appendages: dry skin, urticaria.
Special Senses: amblyopia, eye pain, taste perversion.
Urogenital System: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO AVINZA
Below is a sample of reports where side effects / adverse reactions may be related to Avinza. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Avinza side effects / adverse reactions in 39 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-01
Patient: 39 year old female weighing 56.7 kg (124.7 pounds)
Reactions: Grand MAL Convulsion, Treatment Noncompliance
Adverse event resulted in: hospitalization
Suspect drug(s):
Avinza
Dosage: 120 mg;bid;po
Administration route: Oral
Start date: 2006-04-06
Fentanyl Buccal Tablet
Dosage: 800 ug;prn;bucc
Indication: Breakthrough Pain
Start date: 2005-08-09
Fentanyl Buccal Tablet
Dosage: 800 ug;prn;bucc
Indication: Drug Tolerance
Start date: 2005-08-09
Roxicodone
Dosage: 30 mg;prn;po
Administration route: Oral
Start date: 2005-07-18
Other drugs received by patient: Soma; Xanax; Lexapro; Vytorin; Adderall 10
Possible Avinza side effects / adverse reactions in 62 year old female
Reported by a pharmacist from United States on 2007-04-20
Patient: 62 year old female
Reactions: Grand MAL Convulsion, Renal Injury, Blood Pressure Diastolic
Adverse event resulted in: hospitalization
Suspect drug(s):
Avinza
Narcan
Dosage: 1 dose of narcan given
Possible Avinza side effects / adverse reactions in 35 year old female
Reported by a pharmacist from United States on 2007-05-02
Patient: 35 year old female
Reactions: Abasia, Rhinorrhoea, Inadequate Analgesia, Drug Withdrawal Syndrome, Hyperhidrosis, Hot Flush, Diarrhoea, Pharmaceutical Product Complaint
Suspect drug(s):
Avinza
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