Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Prednisolone Acetate | Pred Forte | 4.8 Undesirable effects | Visual disturbance may be reported with systemic and topical corticosteroid use | Feb, 2025 |
| Telmisartan | Micardis | 4.4 Special warnings and precautions for use. 4.8 Undesirable effects | Intestinal angioedema | Feb, 2025 |
| Tucatinib | Tukysa | 4.4 Special warnings and precautions for use | Prompt medical management should also be instituted in the event of persistence of concomitant Grade 2 diarrhoea with concomitant Grade ≥2 nausea and/or vomiting. | Feb, 2025 |
| 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 |