ADVERSE REACTIONS
Tables 2 and 3 list the most frequently occurring adverse reactions (in at least 5% of patients) from the placebo-controlled trials in patients with low back pain.
Table 2: Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Naïve Patients with Low Back Pain) | Open-Label
Titration Period | Double-Blind Treatment Period |
| OPANA ER | OPANA ER | Placebo |
| Preferred Term | (N = 325) | (N = 105) | (N = 100) |
| | | |
| Constipation | 26.2% | 6.7% | 1.0% |
| Somnolence | 19.1% | 1.9% | 0% |
| Nausea | 18.2% | 11.4% | 9.0% |
| Dizziness | 11.1% | 4.8% | 3.0% |
| Headache | 10.5% | 3.8% | 2.0% |
| Pruritus | 6.8% | 2.9% | 1.0% |
Table 3. Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Experienced Patients with Low Back Pain) | Open-Label
Titration Period | Double-Blind Treatment Period |
| OPANA ER | OPANA ER | Placebo |
| Preferred Term | (N = 250) | (N = 70) | (N = 72) |
| | | |
| Nausea | 19.6% | 2.9% | 1.4% |
| Constipation | 11.6% | 5.7% | 1.4% |
| Headache | 11.6% | 2.9% | 0% |
| Somnolence | 11.2% | 2.9% | 0% |
| Vomiting | 8.8% | 0% | 1.4% |
| Pruritus | 7.6% | 0% | 0% |
| Dizziness | 6.4% | 0% | 0% |
Adverse Reactions Reported in Placebo-Controlled Trials
The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5)
Table 4: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving OPANA ER. | MedDRA Preferred Term | OPANA ER (N=1259) | Placebo (N=461) |
| Nausea | 33.1% | 13.2% |
| Constipation | 27.6% | 13.2% |
| Dizziness (Exc Vertigo) | 17.8% | 7.6% |
| Somnolence | 17.2% | 2.2% |
| Vomiting | 15.6% | 4.1% |
| Pruritus | 15.2% | 7.6% |
| Headache | 12.2% | 5.6% |
| Sweating increased | 8.6% | 8.7% |
| Dry mouth | 6.4% | 0.7% |
| Sedation | 5.9% | 7.6% |
| Diarrhea | 4.3% | 5.6% |
| Insomnia | 4.0% | 2.0% |
| Fatigue | 3.9% | 1.3% |
| Appetite decreased | 2.9% | 0.4% |
| Abdominal pain | 2.5% | 1.5% |
Adverse Reactions Reported in All Clinical Trials
A total of 2011 patients were treated with OPANA ER in the Phase 2/3 controlled and open-label clinical trials. The clinical trials consisted of patients with moderate to severe chronic pain and post surgical pain.
The adverse reactions are presented in the following manner: most common, common, and less common adverse reactions.
The most common adverse drug reactions (≥10%) reported at least once by patients treated with OPANA ER in the clinical trials were nausea, constipation, dizziness (exc. vertigo), vomiting, pruritus, somnolence, headache, sweating increased, and sedation.
The common (≥1% - <10%) adverse drug reactions reported at least once by patients treated with OPANA ER in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class were:
Eye disorders: vision blurred
Gastrointestinal disorders: diarrhea, abdominal pain, dyspepsia
General disorders and administration site conditions : dry mouth, appetite decreased, fatigue, lethargy, weakness, pyrexia, dehydration, weight decreased, edema
Nervous system disorders: insomnia
Psychiatric disorders: anxiety, confusion, disorientation, restlessness, nervousness, depression
Respiratory, thoracic and mediastinal disorders: dyspnea
Vascular disorders: flushing and hypertension
Other less common adverse reactions known with opioid treatment that were seen <1% in the OPANA ER trials include the following in alphabetical order.
Abdominal distention, agitation, allergic reactions, bradycardia, central nervous system depression, clamminess, depressed level of consciousness, dermatitis, difficult micturition, dysphoria, euphoric mood, feeling jittery, hallucination, hot flashes, hypersensitivity, hypotension, hypoxia, ileus, mental impairment, mental status changes, miosis, oxygen saturation decreased, palpitation, postural hypotension, respiratory depression, respiratory distress, respiratory rate decreased, syncope, tachycardia, urinary retention, urticaria, and visual disturbances.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO OPANA ER
Below is a sample of reports where side effects / adverse reactions may be related to Opana ER. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Opana ER side effects / adverse reactions in 48 year old male
Reported by a physician from United States on 2007-03-01
Patient: 48 year old male weighing 122.5 kg (269.4 pounds)
Reactions: Rhabdomyolysis
Suspect drug(s):
Opana ER
Other drugs received by patient: Lunesta; Seroquel; Requip; Benicar
Possible Opana ER side effects / adverse reactions in 39 year old female
Reported by a physician from United States on 2007-03-21
Patient: 39 year old female weighing 68.0 kg (149.7 pounds)
Reactions: Confusional State, Cognitive Disorder, Amnesia
Suspect drug(s):
Opana ER
Possible Opana ER side effects / adverse reactions in 48 year old male
Reported by a physician from United States on 2007-03-28
Patient: 48 year old male weighing 122.5 kg (269.4 pounds)
Reactions: Rhabdomyolysis
Suspect drug(s):
Opana ER
Other drugs received by patient: Lunesta; Seroquel; Requip; Benicar
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