Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Carbidopa / Levodopa | Sinemet | 4.8. Undesirable effects | Addition of Urinary tract infections (frequency: very common) | Apr,2024 |
| Epinephrine | EpiPen | 4.4 Special Warnings and Special Precautions for Use | Risk for adrenaline not reaching the muscle tissue resulting in a suboptimal effect patients with a thick sub-cutaneous fat layer | Apr,2024 |
| Isavuconazonium | Cresemba | "4.4. Special warnings and precautions for use 4.8 Undesirable effects" | "Anaphylactic reaction Immune system disord Aenrsa emia, not known Anaphylactic reaction" | Mar,2024 |
| Maraviroc | Celsentri | 4.3 Contraindications | Contraindicated in patients with severe renal impairment or ESRD (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers. | Mar,2024 |
| Meningitis B Vaccine | Bexsero | 4.8 Undesirable effects | Blood and lymphatic system disorders, Lymphadenopathy | Mar,2024 |
| COVID-19 Vaccine Moderna | Spikevax | 4.4 Special warnings and precautions for use | Altered immunocompetence | Mar,2024 |