Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Alirocumab | Praluent | 4.8 Undesirable effects | Added safety information in pediatrics | Nov,2024 |
| Terlipressin Diacetate Pentahydrate | Glypressin | "4.4 Special warnings and precautions for use. 4.8 Undesirable effects" | Hepatorenal syndrome and advanced renal or liver disease. Adverse events associated with use of Terlipressin in hepatorenal syndrome (i.e. sepsis/septic shock, respiratory failure, respiratory distress) | Nov,2024 |
| Triptorelin | Diphereline P.R. | 4.4 Special warnings and precautions for use | Idiopathic intracranial hypertension | Nov,2024 |
| Mycophenolic acid | Myfortic | 4.8 Undesirable effects | Agranulocytosis, hypersensitivity reactions (including anaphylaxis) and rash | Nov,2024 |
| Venlafaxine | Effexor XR | 4.9 Overdose | Hypoglycaemia | Oct, 2024 |
| larotrectinib | Vitrakvi | 4.4 Special warnings and precautions for use | Hepatotoxicity | Nov,2024 |