FDA Warns Clinicians of Potentially Dangerous Prescribing Error

FDA Warns Clinicians of Potentially Dangerous Prescribing Error
FDA Warns Clinicians of Potentially Dangerous Prescribing Error

The Food and Drug Administration (FDA) is warning healthcare providers and patients that the name confusion between Brintellix (vortioxetine; Takeda and Lundbeck) and Brilinta (ticagrelor; AstraZeneca) has led to the wrong medication being prescribed or dispensed.

Brintellix is a serotonergic agonist and antagonist indicated for the treatment of major depressive disorder (MDD). Brilinta is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina or non-ST-elevation myocardial infarction [MI] or ST-elevation MI).

RELATED: Error-Prone Drug Name Abbreviations

To date, no patients have ingested the incorrect medication but the FDA still reports prescribing and dispensing errors. A total of 50 reports have been received as of June 2015 regarding this brand name confusion; most cases appear to be due to similarities in sound, look, or both sound and look of the two brand names. Although no ingestion of the wrong drug has been reported, in one case Brintellix was misinterpreted as Brilinta, resulting in a pharmacist not dispensing any medication due to the patient having a contraindication to antiplatelet therapy. As a result, the patient went untreated for the psychiatric indication for an unreported period. In the 12 cases where a wrong medication was actually dispensed, the reports showed that:

  • In six cases, the error occurred when prescribing the medication. Five of these prescribing errors occurred during computerized physician order entry. Some CPOE systems auto-populate or present a drop-down menu after the first three letters are typed, at which point a prescriber can select the wrong medication.
  • In the other six cases, the error occurred during dispensing of the medication.

The FDA recommends inclusion of the medication's brand and generic name as well as the indication for use when prescribing these medications. Patients should also verify their prescriptions to make sure that the correct medication was dispensed.

For more information call (888) 463-6332 or visit FDA.gov.

Loading links....