Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Somatrogon | Ngenla | 4.4 Special warnings and precautions for use 4.8 Undesirable effects | Changes in glucose metabolism and including insulin sensitivity Safety in Long-term exposure | Aug, 2025 |
| Depo-Provera | Depo-Provera | 4.3 Contraindications 4.8 Special warnings and precautions for use 4.8 Undesirable effects | Meningioma or history of meningioma. SOC Neoplasms benign, malignant and unspecified: meningioma, | Aug, 2025 |
| Nirmatrelvir / Ritonavir | Paxlovid | 4.6 Fertility, pregnancy and lactation | Nirmatrelvir and ritonavir were estimated to be present in human mild as reported in clinical lactation study | Jul, 2025 |
| Methotrexate | Metoject | 4.6 Fertility, pregnancy and lactation | The exposure during the first trimester of pregnancy increase incidence of spontaneous abortions and multiple adverse developmental outcomes | Jul, 2025 |
| Eptinezumab | Vyepti | 4.4 Special warnings and precautions for use | Hypertension, Raynaud’s Phenomenon | Jul, 2025 |