Stalevo (Page 3 of 8)
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling:
- Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ]
- Hypotension/Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.2) ]
- Dyskinesia [see Warnings and Precautions (5.3) ]
- Depression and suicidality [see Warnings and Precautions (5.4) ]
- Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.5) ]
- Impulse Control and/or Compulsive Behaviors [see Warnings and Precautions (5.6) ]
- Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.7) ]
- Diarrhea and Colitis [see Warnings and Precautions (5.8) ]
- Rhabdomyolysis [see Warnings and Precautions (5.9) ]
- Peptic Ulcer Disease [see Warnings and Precautions (5.13) ]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment/total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.
Entacapone
The most commonly observed adverse reactions (incidence at least 3% greater than placebo incidence) in the double-blind, carbidopa-levodopa-placebo-controlled trials of entacapone (N=1,003 patients) associated with the use of carbidopa-levodopa-entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, dry mouth, and urine discoloration.
The treatment difference incidence for premature study discontinuation for entacapone with levodopa and dopa decarboxylase inhibitor in the double-blind, placebo-controlled trials was 5%. The treatment difference incidence for the most frequent causes of study discontinuation was 2% for diarrhea, and 1% for other specific adverse reactions including psychiatric reasons, dyskinesia/ hyperkinesia, nausea, or abdominal pain.
Adverse Reaction Incidence in Controlled Clinical Studies of Entacapone
Table 2 lists treatment emergent adverse reactions that occurred in at least 1% of patients treated with carbidopa/levodopa and 200 mg of entacapone who participated in the double-blind, placebo-controlled studies, and that were numerically more common in this group than in the carbidopa/levodopa plus placebo group. In these studies, either entacapone or placebo was added to carbidopa/levodopa (or benserazide/levodopa).
SYSTEM ORGAN CLASS | Carbidopa/levodopa plus Entacapone | Carbidopa/levodopa plus Placebo |
---|---|---|
Adverse Reaction | (n=603)% of patients | (n=400)% of patients |
SKIN AND APPENDAGES DISORDERS | ||
Sweating Increased | 2 | 1 |
MUSCULOSKELETAL SYSTEM DISORDERS | ||
Back Pain | 5 | 3 |
CENTRAL AND PERIPHERAL NERVOUS SYSTEM DISORDERS | ||
Dyskinesia | 25 | 15 |
Hyperkinesia | 10 | 5 |
Hypokinesia | 9 | 8 |
Dizziness | 8 | 6 |
SPECIAL SENSES, OTHER DISORDERS | ||
Taste Perversion | 1 | 0 |
PSYCHIATRIC DISORDERS | ||
Anxiety | 2 | 1 |
Somnolence | 2 | 0 |
Agitation | 1 | 0 |
GASTROINTESTINAL SYSTEM DISORDERS | ||
Nausea | 14 | 8 |
Diarrhea | 10 | 4 |
Abdominal Pain | 8 | 4 |
Constipation | 6 | 4 |
Vomiting | 4 | 1 |
Mouth Dry | 3 | 0 |
Dyspepsia | 2 | 1 |
Flatulence | 2 | 0 |
Gastritis | 1 | 0 |
Gastrointestinal Disorders NOS | 1 | 0 |
RESPIRATORY SYSTEM DISORDERS | ||
Dyspnea | 3 | 1 |
PLATELET, BLEEDING AND CLOTTING DISORDERS | ||
Purpura | 2 | 1 |
URINARY SYSTEM DISORDERS | ||
Urine Discoloration | 10 | 0 |
BODY AS A WHOLE-GENERAL DISORDERS | ||
Fatigue | 6 | 4 |
Asthenia | 2 | 1 |
RESISTANCE MECHANISM DISORDERS | ||
Infection Bacterial | 1 | 0 |
6.2 Postmarketing Experience
The following spontaneous reports of adverse events temporally associated with entacapone or Stalevo have been identified since market introduction and are not listed in Table 2. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish causal relationship to entacapone or Stalevo exposure.
Hepatitis with mainly cholestatic features has been reported.
Effects of Gender and Age on Adverse Reactions
No differences were noted in the rate of adverse reactions attributable to entacapone alone by age or gender.
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