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Abuse potential with OROS methylphenidate lower than with other methylphenidate formulations

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
The number of emergency department (ED) reports of abuse with OROS methylphenidate appears to be lower than the number of reports for other formulations of methylphenidate, based on a recent analysis.

Researchers evaluated data from the Drug Abuse Warning Network (DAWN), which is a national health surveillance system that monitors drug-related ED visits. It consists of 2 data sets: 1 that is published annually and includes national estimates of drug-related ED visits based on a sample of hospitals and 1 that consists of an online database used to collect, archive, and retrieve case reports submitted by the sample hospitals. The second data set is restricted and can only be used by federal health agencies and licensed manufacturers of Food and Drug Administration-approved drugs. It contains information that is product- or formulation-specific.

For this analysis, the researchers used the second data set to evaluate ED visits related to drug dependence, abuse, withdrawal, suicidal ideation/gesture, recreational use, or reason unknown from January 2003 through July 2006 for OROS methylphenidate, other methylphenidate formulations (ie, methylphenidate immediate release, methylphenidate sustained release, methylphenidate not otherwise specified, and dexmethylphenidate), atomoxetine, and nonmethylphenidate stimulants (ie, mixed amphetamine salts, dextroamphetamine, and pemoline).

The ratio of abuse potential was calculated by dividing the number of reported ED visits for abuse by the total number of prescriptions dispensed for each drug. Prescription data were provided by IMS Health Inc.

During the study period, there were 1,102 ED reports of abuse for ADHD drugs. Of these, OROS methylphenidate accounted for 89 reports (8%), atomoxetine accounted for 61 reports (6%), other methylphenidate formulations accounted for 301 reports (27%), and non-methylphenidate stimulants accounted for 651 reports (59%).

Despite the number of prescriptions for OROS methylphenidate and other methylphenidate formulations being similar during the study period (approximately 27.8 million vs 25.4 million, respectively), OROS methylphenidate accounted for only 23% of the total reports of abuse involving methylphenidate-based ADHD drugs, whereas the other methylphenidate formulations accounted for 77% of the reports.

The ratio of abuse potential for OROS methylphenidate was lower than that of the other methylphenidate formulations (3.2 x 10^-6 vs 12 x 10^-6). The ratio for OROS methylphenidate was similar to the ratio for atomoxetine (3.5 x 10^-6). Nonmethylphenidate stimulants had the highest ratio of potential abuse, at 14 x 10^-6.

"The compromise-resistant design of OROS methylphenidate may contribute to the disparity between the abuse ratios of OROS methylphenidate and other methylphenidate formulations," the study authors wrote.

"Additional postmarketing surveillance studies are needed to continue assessing relative levels of reported abuse of various stimulant formulations in a real-world setting," they recommended. (Ciccone PE, et al. Poster 325.)

This information concerns uses that have not been approved by the FDA.

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