Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Andexanet alfa | Andexxa | "4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.8 Undesirable effect" | Thromboembolic and ischemic risks, unresponsiveness to heparin | May,2025 |
| Berotralstat | Orladeyo | 4.8 Undesirable effect | Nausea | May,2025 |
| Diphenhydramine hydrochloride,dextromethorphan hydrobromide,pseudoephedrine hydrochloride | Mentex | 4.4 Special warnings and precautions for use | Posterior Reversible Encephalopathy Syndrome (PRES) | May,2025 |
| Risankizumab | Skyrizi | 4.6 Fertility, pregnancy and lactation | IgG antibodies across the placenta | May,2025 |
| Gemcitabine | Gemzar | 4.8 Undesirable effect | Sepsis (Rare), Thrombotic microangiopathy (very rare) | May,2025 |
| Enoxaparin sodium | Inhixa | 4.4 Special warnings and precautions for use | Monitoring of platelet counts, Acute generalized exanthematous pustulosis | May,2025 |