ts of OPANA ER and know how they will react to the medication.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
Respiratory Depression [see Warnings and Precautions (5.2)]
Chronic Pulmonary Disease [see Warnings and Precautions (5.6)]
Head Injuries and Increased Intracranial Pressure [see Warnings and Precautions (5.10)]
Interactions with Other CNS Depressants [see Warnings and Precautions (5.7)]
Hypotensive Effect [see Warnings and Precautions (5.9)]
Gastrointestinal Effects [see Warnings and Precautions (5.11)]
Seizures [see Warnings and Precautions (5.12)]
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of oxymorphone hydrochloride extended-release tablets was eva luated in a total of 2011 patients in open-label and controlled clinical trials. The clinical trials enrolled of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain. The most common serious adverse events reported with administration of oxymorphone hydrochloride extended-release tablets were chest pain, pneumonia and vomiting.
Tables 1 and 2 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 1:Treatment-Emergent Adverse Reactions 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
Oxymorphone Hydrochloride Extended-Release Tablets
Oxymorphone Hydrochloride Extended-Release Tablets
Placebo
Preferred Term
(N = 325)
(N = 105)
(N = 100)
Constipation
26%
7%
1%
Somnolence
19%
2%
0%
Nausea
18%
11%
9%
Dizziness
11%
5%
3%
Headache
11%
4%
2%
Pruritus
7%
3%
1%
Table 2: Treatment-Emergent Adverse Reactions 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
Oxymorphone Hydrochloride Extended-Release Tablets
Oxymorphone Hydrochloride Extended-Release Tablets
Placebo
Preferred Term
(N = 250)
(N = 70)
(N = 72)
Nausea
20%
3%
1%
Constipation
12%
6%
1%
Headache
12%
3%
0%
Somnolence
11%
3%
0%
Vomiting
9%
0%
1%
Pruritus
8%
0%
0%
Dizziness
6%
0%
0%
The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5).
Table 3: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving Oxymorphone Hydrochloride Ex |
