Medication Errors Resulting From Confusion Between Risperidone (Risperdal) And Ropinirole (Requip)
Posted Jun 17 2011 10:21pm
FDA evaluated 226 wrong drug medication errors relating to confusion between risperidone and ropinirole obtained from FDA’s Adverse Event Reporting System database and the Institute for Safe Medication Practices. Several cases resulted in adverse events (n=16), including 5 cases that resulted in hospitalization of the patients. The adverse events occurred due to the administration of incorrect medication and included confusion, lethargy, ataxia, hallucinations, tiredness, dizziness, tingling, numbness and altered mental status. In one of the cases reported from outside the United States, a patient was given Risperdal instead of Requip for one month before a care worker noticed the error. Requip was restarted without titration, and one month after Requip was restarted the patient died. It is unclear what role, if any, the error had in the death of this patient.
FDA determined the causes of confusion between risperidone and ropinirole are multi-factorial in nature. Contributing factors are orthographic similarity of the proprietary (brand) and established (generic) names, similar container labels and carton packaging, illegible handwriting, and overlapping strengths, dosage forms, and dosing intervals between the two products.
The incidence of confusion between the two products increased considerably after 2006 with the introduction of the generic products, which utilize the established (generic) names on the container labels. Generic risperidone was approved in 2006 and generic ropinirole was approved in 2008. However, FDA cannot rule out the possibility that the proprietary (brand) names also may have contributed to the confusion. All of the cases of confusion between risperidone and ropinirole involved tablet formulations.
FDA evaluated 226 wrong drug medication errors relating to confusion between risperidone and ropinirole obtained from FDA’s Adverse Event Reporting System database and the Institute for Safe Medication Practices. Several cases resulted in adverse events (n=16), including 5 cases that resulted in hospitalization of the patients. The adverse events occurred due to the administration of incorrect medication and included confusion, lethargy, ataxia, hallucinations, tiredness, dizziness, tingling, numbness and altered mental status. In one of the cases reported from outside the United States, a patient was given Risperdal instead of Requip for one month before a care worker noticed the error. Requip was restarted without titration, and one month after Requip was restarted the patient died. It is unclear what role, if any, the error had in the death of this patient.
FDA determined the causes of confusion between risperidone and ropinirole are multi-factorial in nature. Contributing factors are orthographic similarity of the proprietary (brand) and established (generic) names, similar container labels and carton packaging, illegible handwriting, and overlapping strengths, dosage forms, and dosing intervals between the two products.
The incidence of confusion between the two products increased considerably after 2006 with the introduction of the generic products, which utilize the established (generic) names on the container labels. Generic risperidone was approved in 2006 and generic ropinirole was approved in 2008. However, FDA cannot rule out the possibility that the proprietary (brand) names also may have contributed to the confusion. All of the cases of confusion between risperidone and ropinirole involved tablet formulations.