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A low discontinuation rate
Focalin® XR (dexmethylphenidate hydrochloride) extended-release capsules provided Attention Deficit Hyperactivity Disorder (ADHD) therapy that patients stayed with in clinical trials.
- No patients receiving Focalin® XR discontinued treatment due to adverse events in a pediatric study (0% versus 2.1% for placebo)1
- Discontinuation rates similar to those seen in pediatric placebo-controlled trials of immediate-release Focalin tablets (0% versus 2.4%
for placebo) 1
- In all trials of immediate-release Focalin tablets, including open-label and dose-ranging studies (n=684), 7.3% of patients discontinued due to adverse events2
- Incidence of irritability in pediatric studies was <5%1
- Observed adverse events are consistent with those of other stimulant medications
A low incidence of adverse events
Patients experienced a low incidence of adverse events
in clinical trials.
*This table lists the incidence of those adverse events that occurred in 5% or more patients receiving Focalin® XR. In children and adolescents, these adverse events occurred at least twice as often with Focalin® XR as with placebo. Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.
REFERENCES:
- Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.
- Focalin [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2001.
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