Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Pitavastatin | Livazo | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Myasthenia gravis and Ocular myasthenia | Feb,2023 |
| Fluvastatin | Lescol XL | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Myasthenia gravis and Ocular myasthenia | Feb,2023 |
| Isatuximab | Sarclisa | 4.4 Special warnings and precautions for use | Serious infusion reactions including severe anaphylactic reactions | May,2023 |
| Lamotrigine | Lamictal | 4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects | Human leukocyte antigen B (HLA-B*1502) allele in Asian has been shown to be associated with the risk of developing Stevens-Johnson syndrome/Toxic epidermal necrolysi when treated with lamotrigine., Motor and/or phonic tics,Pseudolymphoma | Sep,2023 |