Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| METHYLPHENIDATE | Quillivant XR | 4.2 Posology and method of administration | Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established. | Jun, 2026 |
| OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE | SEVIKAR HCT | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Intestinal angioedema | Jun, 2026 |
| Valproate Sodium | Epilim Chrono | 4.2 Posology and Method of Administration 6.6 Special Precautions for Disposal and Handling | Epilim Chrono is a Hazardous drug. Recommended to follow applicable special handling and disposal procedures | Jun, 2026 |
| Marstacimab | HYMPAVZI | 4.8. Undesirable effects | Vascular disorders: Thromboembolic events (thrombosis )* | Jun, 2026 |
| 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 |