Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Tisagenlecleucel | Kymriah | 4.8 Undesirable effects | Haemolysis, haemolytic anemia | Nov,2024 |
| Ibrutinib | Imbruvica | 4.8 Undesirable effects | Cutaneous vasculitis | Nov,2024 |
| Albumin Human | Flexbumin | 4.4 Special warnings and precautions for use | Sodium content | Nov,2024 |
| Human Papillomavirus Type 6 L1,Human Papillomavirus Type 11 L1,Human Papillomavirus Type 16 L1 Protein,Human Papillomavirus Type 18 L1 Protein | Gardasil Recombinant vaccine | 4.8 Undesirable effects | Injection site nodule | Nov,2024 |
| Risankizumab | Skyrizi | 4.6 Pregnancy, lactation and fertility. 4.8 Undesirable effects | Updated safety information for use during pregnancy. Safety information for use in patients with Crohn's disease | Nov,2024 |
| Lopromide | Ultravist | 4.4 Special warnings and precautions for use | Thyroid dysfunction in pediatric patients younger than 3 years | Nov,2024 |