Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Phenytoin Sodium | Epanutin | 4.4 Special warnings and precautions for use | Decrease in CYP2C9*3 activity lead to a decrease in the clearance of phenytoin. | Feb, 2025 |
| Remifentanil | Ultiva | 4.4 Special warnings and precautions for use. 4.5 Interaction with other medicinal products and other forms of interaction. 4.8 Undesirable effects | Tolerance and opioid use disorder Risk of concomitant use with opioids and gabapentinoids withdrawal syndrome, arrythmia. Cough | Jan, 2025 |
| Ibuprofen | Ibudeef | 4.3 Contraindications. 4.6 Fertility, pregnancy and lactation | Contraindicated in third trimester of pregnancy | Jan, 2025 |
| Tagraxofusp | Elzonris | 4.4 Special warnings and precautions for use | Capillary leak syndrome, Hepatotoxicity | Jan, 2025 |
| Nifedipine | Adalat | 4.5 Interaction with other medicinal products and other forms of interaction | Antiarrhythmics,Calcium Channel Blockers,Angiotensin-II Blockers,Beta-blockers | Jan, 2025 |
| Moxifloxacin | Avalox | 4.5. Interactions with other medicinal products | Interactions with Warfarin, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Atenolol | Dec, 2024 |