ADVERSE REACTIONS
The safety of OxyContin® was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
Serious adverse reactions which may be associated with OxyContin Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE).
The non-serious adverse events seen on initiation of therapy with OxyContin are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.
In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as OxyContin therapy is continued and some degree of tolerance is developed.
Clinical trials comparing OxyContin with immediate-release oxycodone and placebo revealed a similar adverse event profile between OxyContin and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:
TABLE 3 | OxyContin
(n=227) | Immediate-Release
(n=225) | Placebo
(n=45) |
|---|
| (%) | (%) | (%) |
|---|
| Constipation | (23) | (26) | (7) |
| Nausea | (23) | (27) | (11) |
| Somnolence | (23) | (24) | (4) |
| Dizziness | (13) | (16) | (9) |
| Pruritus | (13) | (12) | (2) |
| Vomiting | (12) | (14) | (7) |
| Headache | (7) | (8) | (7) |
| Dry Mouth | (6) | (7) | (2) |
| Asthenia | (6) | (7) | - |
| Sweating | (5) | (6) | (2) |
The following adverse experiences were reported in OxyContin®-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.
The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience.
General: accidental injury, chest pain, facial edema, malaise, neck pain, pain, and symptoms associated with either an anaphylactic or anaphylactoid reaction
Cardiovascular: migraine, syncope, vasodilation, ST depression
Digestive: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, nausea and vomiting, stomatitis, ileus
Hemic and Lymphatic: lymphadenopathy
Metabolic and Nutritional: dehydration, edema, hyponatremia, peripheral edema, syndrome of inappropriate antidiuretic hormone secretion, thirst
Nervous: abnormal gait, agitation, amnesia, depersonalization, depression, emotional lability, hallucination, hyperkinesia, hypesthesia, hypotonia, malaise, paresthesia, seizures, speech disorder, stupor, tinnitus, tremor, vertigo, withdrawal syndrome with or without seizures
Respiratory: cough increased, pharyngitis, voice alteration
Skin: dry skin, exfoliative dermatitis, urticaria
Special Senses: abnormal vision, taste perversion
Urogenital: amenorrhea, decreased libido, dysuria, hematuria, impotence, polyuria, urinary retention, urination impaired
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO OXYCONTIN
Below is a sample of reports where side effects / adverse reactions may be related to Oxycontin. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Oxycontin side effects / adverse reactions in 16 year old female
Reported by a lawyer from United States on 2007-01-03
Patient: 16 year old female
Reactions: Metabolic Acidosis, Pneumonia Aspiration, Anoxic Encephalopathy, Coagulopathy, Encephalopathy, Hepatic Enzyme Increased, Multi-Organ Failure, Overdose, Euphoric Mood, Cardio-Respiratory Arrest, Renal Failure, Completed Suicide, Sepsis, Hypocalcaemia, Brain Oedema
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Paxil
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Oxycontin
Dosage: 560mg single dose
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2004-11-09
End date: 2004-11-09
Other drugs received by patient: Zyprexa; Doxycycline
Possible Oxycontin side effects / adverse reactions in 74 year old male
Reported by a individual with unspecified qualification on 2007-01-08
Patient: 74 year old male
Reactions: Weight Gain Poor, Weight Decreased, Stomach Discomfort, Insomnia, Myocardial Infarction, Abdominal Pain Upper
Suspect drug(s):
Oxycontin
Other drugs received by patient: Protonix; Ativan; Thyroid Hormones
Possible Oxycontin side effects / adverse reactions in 22 year old male
Reported by a individual with unspecified qualification from United States on 2007-01-11
Patient: 22 year old male
Reactions: Death, Substance Abuse
Adverse event resulted in: death
Suspect drug(s):
Oxycontin
Dosage: unk, unk
Indication: Drug Abuser
Methadone HCL
Dosage: unk, unk
Indication: Drug Abuser
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