Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Hydrochlorothiazide,Olmesartan | Olmetec Plus | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Acute respiratory distress syndrome (ARDS) | Sep,2022 |
| Baricitinib | Olumiant | 4.4 Special Warnings and Special Precautions for Use | Serious heart-related problems, thrombosis, malignancies, mortality | Sep,2022 |
| 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 |