Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Aalirocumab | Praluent | 4.8 Undesirable effects | Added safety information in pediatrics | Sep, 2024 |
| Palbociclib | Ibrance | "4.5. Interactions with other medicinal products 4.8, Undesirable effects" | "Interaction with statins Blood creatinine increased and Erythema multiforme" | Sep, 2024 |
| Human Papillomavirus Type 6 L1,Human Papillomavirus Type 11 L1,Human Papillomavirus Type 16 L1 Protein,Human Papillomavirus Type 18 L1 Protein,Human Papillomavirus Type 31 L1 Protein,Human Papillomavirus Type 33 L1 Protein,Human Papillomavirus Type 45 L1 Protein,Human Papillomavirus Type 52 L1 Protein,Human Papillomavirus Type 58 L1 Protein | Gardasil 9 | 4.6. Fertility, pregnancy and lactation | Updated post marketing safety information during pregnancy "six-year pregnancy registry results" | Sep, 2024 |
| Albumin Human | Human Albumin 20% | 4.4 Special Warnings and Special Precautions for Use | Added Sodium content | Sep, 2024 |
| Tizanidine | Sirdalud | 4.6. Fertility, pregnancy and lactation | In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically | Sep, 2024 |
| Linezolid | Zyvox | "4.4 Special Warnings and Special Precautions for Use. 4.8 Undesirable effects" | Rhabdomyolysis | Sep, 2024 |