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Regulatory News | 31 July 2015 | By Michael Mezher
The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names.
When a new drug is submitted to FDA for review, the agency's Division of Medication Error Prevention conducts a review of the product's proposed brand name. FDA's main concern in reviewing the brand names of drugs is to ensure that a drug's brand name does not look or sound like one already approved.
Last year, FDA released a draft guidance, Best practices in Developing Proprietary Names for Drugs, which focused heavily on practices to reduce confusion for patients.
For more information on FDA's draft guidance on proprietary names see Focus articles "What's in a Drug Name? FDA Explains in New Draft Guidance" and"What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes"
FDA says it has received 50 reports of medication errors involving Brintellix, an antidepressant, and Brilinta, a blood thinner, as of June 2015. Most of the errors pointed to similarities between the two drugs' brand names.
The agency says 12 of the reports resulted in a patient being given the wrong drug; however, none of the reports indicate that a patient actually consumed the wrong drug. Of these 12 cases, FDA says half resulted from errors in the prescription and half were due to errors when the drugs were dispensed.
One particular case involved a pharmacist refusing to dispense a prescription to a patient after confusing Brintellix for Brilinta, "because the patient had a contraindication to blood thinners."
FDA says several factors have contributed to the confusion between the two drugs' names:
Both brand names begin with the same three letters.Both brand names are presented when selecting medications in a computerized physician order entry (CPOE) system.The pharmacist was not familiar with the new medication Brintellix and so dispensed Brilinta.The brand names look and sound similar.
FDA is urging patients taking either product to inspect their prescriptions and verify they contain the correct product. The two drugs are physically distinguishable, Brintellix is a tear-shaped pill stamped "TL 5," and may come in pink, yellow, orange or red; whereas Brilinta is round and yellow, with the characters "T" and "90" imprinted on it.
Tags: Brand names, Proprietary names, Drug naming, Medication errors, Brintellix, Brilinta