Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Bupropion Hydrochloride; Naltrexone Hydrochloride | Wellbutrin | 4.8 Undesirable effects | Alopecia | Aug, 2024 |
| Valproate Sodium | Depakine | "4.6. Fertility, pregnancy and lactation , 5.3 Preclinical Safety Data" | In utero exposure to valproate may result in hearing impairment or deafness and eye malformations. Reproductive and developmental toxicity have been reported in animal studies | Dec,2023 |
| Sotorasib | Lumykras | "4.2 Posology and method of administration , 4.5. Interactions with other medicinal products" | Interaction with omeprazole and Breast cancer resistance protein (BCRP) substrate | Dec,2023 |
| Asciminib | Scemblix | 4.5. Interactions with other medicinal products | Interaction with OATP1B and BCRP substrates, rosuvastatin and atorvastatin | Nov,2023 |
| Zanubrutinib | Itrazol | "4.3 Contraindications , 4.5. Interactions with other medicinal products" | "4.3 Contraindications 4.5. Interactions with other medicinal products" "Co-administration of Cytochrome (CYP3A4) substrates is contraindicated with ITRAZOL " | Nov,2023 |
| Warfarin Sodium | Coufatex | 4.5. Interactions with other medicinal products | Interactions with Ibrutinib. | Nov,2023 |