Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Tenofovir Alafenamide Fumarate | Vemlidy | 4.4 Special Warnings and Special Precautions for Use | Nephrotixity warning, acute renal failure, and proximal renal tubulopathy | Sep,2022 |
| Lixisenatide, Insulin Glargine | Soliqua | 4.8 Undesirable effects | Delayed gastric emptying | Sep,2022 |
| Alglucosidase Alfa | Myozyme | 4.8 Undesirable effects | Hypoxia, Abdominal pain Retching , Dyspepsia, Dysphagia, Palmar erythema, Transient skin discoloration, Blister, Infusion site erythema, Infusion site urticaria | Sep,2022 |
| Dolutegravir | Tivicay | 4.4 Special Warnings and Special Precautions for Use | Remove the disease information relating to sexual transmission of HIV "While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines." | Sep,2022 |
| Eliglustat | Cerdelga | 4.2 Posology And Method Administration 6.6. Special precautions for disposal and other handling | SFDA requested SPC/ PIL update to all registered hazardous medications to add the proposed language regarding safe handling and disposal of hazardous medications in order to ensure safety of patients, healthcare professionals, and family caregivers. | Sep,2022 |
| Oxcarbazepine | Trileptal | 4.2 Posology And Method Administration 6.6. Special precautions for disposal and other handling | SFDA requested SPC/ PIL update to all registered hazardous medications to add the proposed language regarding safe handling and disposal of hazardous medications in order to ensure safety of patients, healthcare professionals, and family caregivers. | Sep,2022 |