Brilinta FDA Alerts

Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

ISSUE: AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.

Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor. Brilinta has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of Brilinta increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of Brilinta have a higher risk of getting a blood clot in the stent, having a heart attack, or death. Patients should not stop taking Brilinta without talking to their prescribing doctor. To date, AstraZeneca has not received any reports of adverse events related to this recall.

BACKGROUND: This is limited to one lot (Brilinta lot #JB5047) of professional sample bottles containing eight tablets of Brilinta 90 mg distributed to physicians in the US between March and April of 2017. Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this voluntary recall. This recall does not affect Zurampic.

Brilinta is indicated to reduce the rate of CV death, heart attack and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Zurampic is a prescription medicine used together with a xanthine oxidase inhibitor such as allopurinol or Uloric in adults with gout who still have a high uric acid level.

Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with 90 above a T on one side of the pill. Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side of the pill.

RECOMMENDATION: AstraZeneca is notifying physicians by recall letter and is arranging for return of all recalled products. Consumers that have medicine which is being recalled should contact their physician.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[05/24/2017 - News Release - AstraZeneca]

Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)

ISSUE:  FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.

Because of the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period.

In a July 2015 MedWatch Alert, FDA warned that name confusion between Brintellix and Brilinta had resulted in prescribing and dispensing errors since Brintellix was approved in September 2013. Due to continued reports of name confusion between the two medicines used for very different purposes, FDA worked with Brintellix manufacturer Takeda Pharmaceuticals to change the drug’s brand name.

BACKGROUND: Brintellix/Trintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder in adults. It is in a class of antidepressants called serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced.

RECOMMENDATION: Health care professionals should check carefully to make sure they have prescribed or dispensed the correct medicine. During the transition to the new name change from Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. Patients should make sure they have received the correct medicine. Trintellix tablets will look the same as the Brintellix tablets. Those having any questions or concerns should talk to their prescriber or pharmacist.

Individuals responsible for ordering and stocking the medicine should be aware that Trintellix will have a new National Drug Code (NDC) number. It is important for drug information content publishers and medication-related electronic system administrators to use the new brand name Trintellix and NDC number once Takeda makes vortioxetine available under the new name Trintellix.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/02/2016 - Drug Safety Communication - FDA]

Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion

ISSUE: FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue. 

BACKGROUND: Brintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder (MDD) in adults.  It is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Brilinta (ticagrelor) is an antiplatelet, anti-blood clotting medication used to lower the risk of having another heart attack, or dying from a heart problem after a heart attack or severe chest pain.

RECOMMENDATION: Health care professionals can reduce the risk of name confusion by including the generic (established) name of the medication, in addition to the brand name, and the indication for use when prescribing these medications. Patients should check their prescriptions to ensure that the correct medication was dispensed. See the FDA Drug Safety Communication for more detailed recommendations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/30/2015 - Drug Safety Communication - FDA]