Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Allopurinol | Loric | 4.6. Fertility, pregnancy and lactation | Based on findings in animals, Allopurinol may cause fetal harm when administered to a pregnant woman. Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. Advise pregnant women of the potential risk to a fetus. | Sep,2022 |
| Pneumococcal conjugate vaccine | Prevenar | 4.4. Special warnings and precautions for use | The potential risk of apnoea when adminster | Mar,2024 |
| Telotristat Ethyl | Xermelo | 4.8 Undesirable effects | Angioedema, pruritis, rash | Sep,2022 |
| Alemtuzumab | Lemtrada | 4.8 Undesirable effects 4.4. Special warnings and precautions for use | Autoimmune Encephalitis, myasthenia gravis, Lambert-Eaton myasthenic syndrome,Autoimmune Encephalitis | Sep,2022 |
| Dabigatran | Pradaxa | 4.6 Fertility, pregnancy and lactation | Uterine bleeding | Sep,2022 |
| Rivaroxaban | Xarelto | 4.6 Fertility, pregnancy and lactation | Uterine bleeding | Sep,2022 |