Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Telotristat Ethyl | Xermelo | 4.8 Undesirable effects | Angioedema, pruritis, rash | Sep,2022 |
| Alemtuzumab | Lemtrada | 4.8 Undesirable effects 4.4. Special warnings and precautions for use | Autoimmune Encephalitis, myasthenia gravis, Lambert-Eaton myasthenic syndrome,Autoimmune Encephalitis | Sep,2022 |
| Dabigatran | Pradaxa | 4.6 Fertility, pregnancy and lactation | Uterine bleeding | Sep,2022 |
| Rivaroxaban | Xarelto | 4.6 Fertility, pregnancy and lactation | Uterine bleeding | Sep,2022 |
| Cladribine | Mavenclad | 4.4 Special Warnings and Special Precautions for Use | Vaccination with zoster vaccine recombinant, adjuvanted is recommended for patients who are seropositive to VZV, either prior to or during MAVENCLAD treatment, including when their lymphocyte counts are less than or equal to 500 cells per microliter. | Sep,2022 |
| Apixaban | Eliquis | 4.6 Fertility, pregnancy and lactation | Uterine bleeding | Sep,2022 |