Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Gabapentin | Neurontin | 4.6 Fertility, pregnancy and lactation | Neonatal withdrawal syndrome | Nov,2022 |
Durvalumab | Imfinzi | 4.8. Undesirable effects | Myelitis transverse | Nov,2022 |
Elasomeran (COVID-19 mRNA vaccine ) | Spikevax | 4.8. Undesirable effects | Heavy menstrual bleeding | Nov,2022 |
Tozinameran (COVID-19 mRNA vaccine ) | Comirnaty | 4.8. Undesirable effects | Heavy menstrual bleeding | Nov,2022 |
Dorzolamide | Trusopt | 4.8 Undesirable effects | Tachycardia, Hypertension | Nov,2022 |
Ertugliflozin, Sitagliptin | Steglujan | 4.5. Interactions with other medicinal products | Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations | Oct,2022 |