Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Lansoprazole | Lanzor | 4.4. Special warnings and precautions for use | Acute tubulointerstitial nephritis | Oct,2022 |
| Dexlansoprazole | Dexilant | 4.4. Special warnings and precautions for use | Acute tubulointerstitial nephritis | Oct,2022 |
| Dexketoprofen | Ketesse | 4.6. Fertility, pregnancy and lactation | Cause oligohydramnios resulting from foetal renal dysfunction | Oct,2022 |
| Ciclosporin | Sandimmun | 4.8 Undesirable effects | Hearing impairment | Oct,2022 |
| Donepezil | Dementile | 4.8 Undesirable effects | Libido increased, hypersexuality , Pleurothotonus (Pisa syndrome) | Oct,2022 |
| Lamotrigine | Lamictal | 4.6. Fertility, pregnancy and lactation | In animal studies lamotrigine was not teratogenic in animal reproductive studies involving mice, rats, and rabbits using oral doses that were 125, 25, and 30 mg/kg, respectively, during organogenesis. However, maternal toxicity and secondary fetal toxicity consisting of increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities at doses lower than those administered clinically. Lamotrigine decreased fetal folate concentrations in rats, an effect known to be associated with adverse pregnancy outcomes in animals and humans | Oct,2022 |