Extended Indication and New Strength Tablet for Brilinta
September 3, 2015 – The U.S. Food and Drug Administration (FDA) approved an extended indication and a new strength tablet for Brilinta (ticagrelor), a platelet inhibitor. Previously approved by the FDA in 2011, Brilinta was indicated to decrease the risk of heart attacks, strokes, and cardiovascular-related death for patients who have acute coronary syndrome (ACS) or who have already had a heart attack. FDA’s new indication for Brilinta extends treatment beyond one year at a low dose of 60mg twice daily rather than the 90mg as it was originally approved. Brilinta labels will continue to have boxed warnings that using it may increase the risk of significant bleeding and that taking more than 100mg of aspirin per day decreases Brilinta’s effectiveness. The 60mg Brilinta tablets are scheduled to be launched in the third quarter of 2015 by AstraZeneca.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.