Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Infliximab | Xifi | 4.8 Undesirable effects | New onset immune disorders (e.g., psoriasis, rheumatoid arthritis, inflammatory bowel disease) and Rheumatoid arthritis | Feb,2026 |
| Azithromycin | Zithromax | "4.4 Special warnings and precautions for use 4.8 Undesirable effects" | The risk of acute cardiovascular death | Feb,2026 |
| Ketorolac Tromethamine | Acuvail Ophthalmic Solution | 4.6 Fertility, pregnancy and lactation | Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACUVAIL during late pregnancy should be avoided. | Feb,2026 |
| Gadoteric Acid | Dotarem | 4.8. Undesirable effects | Gastrointestinal Disorders: diarrhea, salivary hypersecretion, acute pancreatitis with onset within 48 hours after GBCA administration. | Jan, 2026 |
| Quetiapine | Seroquel Xl | 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction | Serotonin syndrome Quetiapine should be used with caution in combination with serotonergic medicinal products | Jan, 2026 |
| Dexketoprofen | Ketesse | 4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects | Warnings for serious exacerbation of infections Warning on the use of DKP after pregnancy week 20 Kounis syndrome | Jan, 2026 |