Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Omeprazole | Losec Mups | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Acute tubulointerstitial nephritis , Tubulointerstitial nephritis | Jan,2023 |
| Cefuroxime | Zinnat | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Hypersensitivity reactions, Severe cutaneous adverse reactions. Drug Reaction with Eosinophilia and Systemic Symptoms , Kounis syndrome | Jan,2023 |
| Erythromycin | Erythrodar | 4.6 Fertility, pregnancy and lactation | Congenital malformations | Jan,2023 |
| Amoxicillin | Amoxil | 4.4 Special Warnings and Special Precautions for Use , 4.5. Interactions with other medicinal products , 4.8 Undesirable effects | Hypersensitivity reactions can also progress to Kounis syndrome, Drug-induced enterocolitis syndrome, acute renal injury. Interactions with probenecid such as methotrexate. Linear Immunoglobulin A (IgA) disease, Aseptic meningitis, Kounis syndrome, Drug-induced enterocolitis syndrome, Crystalluria | Jan,2023 |
| Amoxicillin/clavulanate | Augmentin | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Drug-induced enterocolitis syndrome, acute renal injury , Drug-induced enteLinear Immunoglobulin A (IgA) disease, Drug-induced enterocolitis syndrome, Pancreatitis acute | Jan,2023 |
| Fexofenadine | Telfast | 4.5. Interactions with other medicinal products, 4.8 Undesirable effects | Interactions with P-glycoprotein inhibitors or inducers, Vision blurred | Jan,2023 |