Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Olmesartan medoxomil,amlodipine besilate | Sevikar | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Intestinal angioedema | Sep, 2025 |
| Cariprazine hydrochloride | Reagila | 4.5. Interaction with other medicinal products and other forms of interaction | Strong or moderate CYP 3A4 inhibitors, and CYP 3A4 inducers | Sep, 2025 |
| Ibuprofen | Pedea | 4.4 special warnings and precautions for use 4.8 undesirable effects | Serious skin reactions. Acute generalised exanthematous pustulosis (agep) | Sep, 2025 |
| Somatrogon | Ngenla | 4.4 special warnings and precautions for use 4.8 undesirable effects | Changes in glucose metabolism. Patients received treatment with somatrogon for at least 5 years. No additional safety findings were reported. | Sep, 2025 |
| Certolizumab pegol | Cimzia | 4.8. Undesirable effects 4.6. Fertility, pregnancy and lactation | Update in Human data , pregnancy registry data and Cimzia use during breastfeeding. | Sep, 2025 |
| Sulfasalazine | Salazopyrin-en | 4.8. Undesirable effects | Hypoprothrombinaemia | Sep, 2025 |