Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Dexlansoprazole | Dexilant | 5.2 Pharmacokinetic properties | Effect of CYP2C19 Polymorphism on Systemic Exposure of Dexlansoprazole | Jul, 2024 |
| Dexketoprofen | Ketesse | 4.6. Fertility, pregnancy and lactation | Cause oligohydramnios resulting from foetal renal dysfunction | Oct,2022 |
| Ciclosporin | Invokana | 4.5 Interaction with other medicinal products and other forms of interaction | "Lithium " | Jan,2024 |
| 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 |
| Ondansetron | Dansetron | 4.6. Fertility, pregnancy and lactation | Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy. Available post-marketing data have not identified a drug associated risk of miscarriage or adverse maternal outcomes. Reproductive animal studies did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area (BSA), respectively "Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. One large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks (RR) ranged from 0.97 (95% CI 0.86 to 1.10) to 1.62 (95% CI 1.04, 2.54). A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (RR 2.05, 95% CI 1.19, 3.28); however, this association was not confirmed in other studies." | Sep,2022 |