Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Upadacitinib | Rinvoq | 4.4 Special Warnings and Special Precautions for Use | Serious heart-related problems, thrombosis, malignancies, mortality | Sep,2022 |
| Vigabatrin | Sabril | 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 |
| Valproate Sodium | Depakine | 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 |
| Deferiprone | Ferriprox | 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 |