Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Tamsulosin | Omnic ocas | 4.8. Undesirable effects | Photosensitivity | Sep, 2025 |
| Naproxen | Aleve | 4.6 Fertility, pregnancy and lactation | Risks of oligohydramnios, ductus arteriosus stenosis | Aug, 2025 |
| Metformin Hydrochloride,Dapagliflozin | Xigduo XR | 4.4 Special warnings and special precautions for use 4.8 Undesirable effects 4.5 Interaction with other medicinal products and other forms of interaction | Patients with renal impairment Vitamin B12 decrease , use in patients with heart failure with reduced ejection fraction and in patients with chronic kidney disease Concomitant use of dapagliflozin and lithium | Aug, 2025 |