The following serious adverse reactions are discussed below and elsewhere in labeling: Gastrointestinal and Gastrointestinal Procedure-Related Risks [see Warnings and Precautions ( 5.1 ) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.2 ) ] Orthostatic Hypotension [see Warnings and Precautions ( 5.3 ) ] Hallucinations/Psychosis/Confusion [see Warnings and Precautions ( 5.4 ) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.5 ) ] Depression and Suicidality [see Warnings and Precautions ( 5.6 ) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.7 ) ] Dyskinesia [see Warnings and Precautions ( 5.8 ) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions ( 5.9 )] Neuropathy [see Warnings and Precautions ( 5.10 ) ] Cardiovascular Ischemic Events [see Warnings and Precautions ( 5.11 ) ] Laboratory Test Abnormalities [see Warnings and Precautions ( 5.12)] Glaucoma [see Warnings and Precautions ( 5.13 ) ] Most common adverse reactions for DUOPA (DUOPA incidence at least 7% greater than oral carbidopa-levodopa incidence) were: complication of device insertion, nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, and incision site erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience
Because clinical studies are run under widely varying conditions, the incidence of adverse reactions 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 practice. In clinical studies, 416 patients with advanced Parkinson’s disease received DUOPA. 338 patients were treated with DUOPA for more than 1 year, 233 patients were treated with DUOPA for more than 2 years, and 162 patients were treated with DUOPA for more than 3 years.
In a 12-week, active-controlled clinical trial (Study 1), a total of 71 patients with advanced Parkinson’s disease were enrolled and had a PEG-J procedure. Of these, 37 patients received DUOPA and 34 received oral immediate-release carbidopa-levodopa. The most common adverse reactions for DUOPA (incidence at least 7% greater than oral immediate-release carbidopa-levodopa) were: complication of device insertion, nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, and incision site erythema.
Table 3 lists the incidence of adverse reactions occurring in the DUOPA-treated group (requiring at least 2 patients in this group) in Study 1 when the incidence was numerically greater than that for oral immediate-release carbidopa-levodopa. Table 3. Adverse Reactions in Study 1 for DUOPA in Patients with Advanced Parkinson’s disease Preferred Term DUOPA (n = 37) % Oral immediate-release carbidopa-levodopa a (n = 34) % Complication of device insertion 57 44 Nausea 30 21 Constipation 22 21 Incision site erythema 19 12 Dyskinesia 14 12 Depression 11 3 Post procedural discharge 11 9 Peripheral edema 8 0 Hypertension 8 0 Upper respiratory tract infection 8 0 Oropharyngeal pain 8 0 Atelectasis 8 0 Confusional state 8 3 Anxiety 8 3 Dizziness 8 6 Hiatal hernia 8 6 Postoperative ileus 5 0 Sleep disorder 5 0 Pyrexia 5 0 Excessive granulation tissue 5 0 Rash 5 0 Bacteriuria 5 0 White blood cells urine positive 5 0 Hallucination 5 3 Psychotic disorder 5 3 Diarrhea 5 3 Dyspepsia 5 3 a All patients in the clinical trial regardless of treatment arm received a PEG-J.
Procedure and Device- Related Adverse Reactions The most common adverse reactions associated with complications due to naso-jejunal (NJ) insertion were: oropharyngeal pain, abdominal distention, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal injury, esophageal hemorrhage, anxiety, dysphagia, and vomiting. The most common adverse reactions associated with complications due to PEG-J insertion were: abdominal pain, abdominal discomfort, abdominal distension, flatulence, or pneumoperitoneum.
Additional adverse reactions that were co-reported with complication of naso-jejunal and PEG-J insertion included upper abdominal pain, duodenal ulcer, duodenal ulcer hemorrhage, erosive duodenitis, erosive gastritis, gastrointestinal hemorrhage, intussusception, peritonitis, post-operative abscess, and small intestine ulcer.
