Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Cyclophosphamide | Endoxan | "4.4. Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.6 Fertility, pregnancy and lactation" | "Dose adjustment due to myelosuppression is recommended , Men treated with cyclophosphamide should be informed about sperm preservation prior to treatment Clozapine, CYP2B6 and CYP3A4 inhibitors, Grapefruit Contraception in males and females" | Feb,2024 |
| Pilocarpine Hydrochloride | Apicarpine | 4.6 Fertility, pregnancy and lactation | Human and animal data | Feb,2024 |
| Hydroxyurea | CureamL | "4.4. Special warnings and precautions for use 4.6. Fertility, pregnancy and lactation 4.8. Undesirable effects" | "Bone Marrow , Anaemia, HIV , cancer Azoo- or oligospermia, sometimes reversible, have been observed in men. Male patient should be informed about the possibility of sperm conservation before the start of therapy. hydroxyurea may be genotoxic. Men under therapy are advised to use effective contraceptive Hypersensitivity, Drug induced fever, Tumour lysis syndrome" | Jan,2024 |
| Ibuprofen | Prof | 4.4 Special Warnings and Special Precautions for Use | Masking of symptoms of underlying infections | Sep, 2024 |
| 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 |