Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Rosuvastatin | Crestor | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Myasthenia gravis and Ocular myasthenia | Feb,2023 |
| Pegcetacoplan | Syfovre | 4.8 Undesirable effects | Retinal Vasculitis and/or Retinal Vascular Occlusion | Dec,2023 |
| Fluvastatin | Lescol Xl | 4.4 Special Warnings and Special Precautions for Use | Lichen planus , myasthenia gravis | Dec,2023 |
| Hydroxyurea | Hydrea | 4.5. Interactions with other medicinal products | Lab tests interactions | Dec,2023 |
| Bupropion Hydrochloride; Naltrexone Hydrochloride | Contrave | 4.4 Special Warnings and Special Precautions for Use | Brugada pattern/syndrome | Dec,2023 |
| 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 |