Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Carbamazepine | Tegretol | "4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects" | "Class I (immediate) hypersensitivity reactions Pregnancy risk related to carbamazepine and Risk in women of childbearing potential hyperammonaemia" | Mar,2024 |
| Teriflunomide | Aubagio | 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 |
| Olaparib | Lynparza | 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 |
| Zidovudine | Retrovir | 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 |
| Mycophenolate mofetil | Cellcept | 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 |
| Ceritinib | Zykadia | 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 |