Label Changes for:
Lysteda (tranexamic acid) Tablets
Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- using combination hormonal contraception
WARNINGS AND PRECAUTIONS
Concomitant Use of Hormonal Contraceptives
- Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because Lysteda is antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when hormonal contraceptives are administered with Lysteda. This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.
- Women using hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of Lysteda, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of Lysteda with hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used Lysteda concomitantly with combination hormonal contraceptives. For this reason, concomitant use of Lysteda with combination hormonal contraceptives is contraindicated.
- Because Lysteda is antifibrinolytic, concomitant use of hormonal contraception and Lysteda may further exacerbate the increased thrombotic risk associated with combination hormonal contraceptives. For this reason, concomitant use of Lysteda with combination hormonal contraceptives is Contraindicated.
5 WARNINGS AND PRECAUTIONS
5.1 thromboembolic Risk
- ...Concomittant Use of Hormonal Contraceptives...
5.4 Ligneous Conjunctivitis
- section added