FDA Reports Requip, Risperdal Medication Errors

June 14, 2011 -- The FDA has issued an alert about medication errors involving patients who were mistakenly given the antipsychotic risperidone, (brand name Risperdal) instead of ropinirole (Requip), which is used to treat Parkinson’s disease and restless legs syndrome, or vice versa.

Some patients who took the wrong medication wound up in a hospital for treatment of symptoms such as confusion, lethargy, hallucinations, tiredness, dizziness, tingling, numbness, and altered mental status.

One person outside the U.S. who received the wrong medicine died, but the FDA says it is not known what role, if any, the medication error played in the death. The person had taken Risperdal for a month stead of Requip. After the error was found, the patient was restarted on Requip for a month before dying.

Dangers of Medication Errors

FDA says it has evaluated 226 wrong-drug medication errors relating to confusion between the two drugs, including five requiring hospitalization.

Factors causing this confusion include:

• Similarities of both the brand and generic names.
• Illegible handwriting on prescriptions.
• Similarities of the container labels and carton packaging.
• Overlapping product characteristics, such as dosage forms, dosing intervals, and drug strength.

The FDA says it is asking manufacturers of the brand-name medications and their generic counterparts to take measures to reduce the potential for confusion between the two products.

The agency requests:

• Use of “tall man” lettering on container labels and carton packaging, to present the generic names as risperiDONE and rOPINIRole. This may improve the ability of health care professionals to tell the difference between the two drug names.
• Changing individual labels and carton packaging to provide better visual differentiation between the generic products for risperidone and ropinirole in order to reduce the potential for confusion.

Generic Medications Increased Confusion?

Confusion between the two products increased considerably after 2006 with the introduction of the generic products, which feature the generic names on container labels.

Generic risperidone was approved in 2006 and generic ropinirole was approved in 2008.

The FDA says it can’t rule out the possibility that the brand names may also have contributed to the confusion that has caused some people to take Risperdal when they should have been receiving Requip, and vice versa.

The FDA’s alert reminds patients taking Requip, Risperdal, or their generic equivalents to know the name and appearance of their medication, the reason why they are taking it, and to ask questions if the medication looks different from what they expect.

Risperidone is an antipsychotic medication used to treat such mental illnesses as schizophrenia, bipolar disorder and irritability associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist that is used in the treatment of restless legs syndrome and Parkinson’s disease.

Risperdal is made by Johnson & Johnson, and Requip by GlaxoSmithKline.