Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Valproate Sodium | Depakine | 4.6. Fertility, pregnancy and lactation 5.3 Preclinical Safety Data | Congenital hearing and eye abnormalities following in utero valproate exposure. New preclinical and clinical evidence regarding testicular toxicity and male infertility. | May,2026 |
| Sertraline Hydrochloride | Lustral | 4.8 Undesirable effects | Multiple Acyl Coenzyme A Dehydrogenase Deficiency (MADD) disorder | April, 2026 |
| ATOGEPANT | Aquipta | 4.4 Special warnings and precautions for use 4.8 Undesirable effects section | Hypertension, Raynaud’s Phenomenon | April, 2026 |
| ASCORBIC ACID,SODIUM ASCORBATE,SODIUM SULFATE,MACROGOL ,POTASSIUM CHLORIDE,SODIUM CHLORIDE | Moviprep | 4.4 Special warnings and precautions for use | Hypersensitivity reactions | Mar,2026 |
| 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 |