These are unwanted effects that you consider are linked to taking a medicine. Side effects also include any effects from: misuse, abuse, an error in the way the medicine has been given or overdose (taking too much medicine). Reports can be made for any medicine (including specials and unlicensed products), any vaccine, herbal product, and complimentary remedies such as homeopathic remedies, blood factors (. factors I to XIII) and immunuloglobulins (. anti-D (RHO) immunoglobulin). You can even report suspected side effects from a drug you think might be happening as a result of interactions with food and drink.
In a multigenerational developmental study in pregnant rats given oral gavage doses of , 1, 3 g/kg/day ethyl-EPA from gestation day 7-17, an increased incidence of absent optic nerves and unilateral testes atrophy were observed at ≥ g/kg/day at human systemic exposure following an oral dose of 4 g/day based on body surface area comparisons across species. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting multigenerational effects of ethyl-EPA at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species.
Gabapentin is excreted in human breast milk. A breast-feeding infant could be exposed to a maximum gabapentin dose of approximately 1 mg/kg/day. The effects of gabapentin on the breast-fed infant and milk production are unknown. Because of the potential for adverse reactions in breast-feeding infants, discontinue breast-feeding or gabapentin enacarbil, taking into account the importance of the drug to the mother. For other gabapentin products, consider the developmental and health benefits of breast-feeding along with the mother's clinical need for gabapentin and any potential adverse effects on the breast-fed infant from gabapentin or the underlying maternal condition. Only use gabapentin in breast-feeding women if the benefits clearly outweigh the risks. The infant dose of gabapentin excreted in breast milk was examined in 4 infants, 3 of which were 2 to 3 weeks of age and 1 who was approximately 3 months old. The average daily maternal dosage of gabapentin was 1,575 mg (range, 600 to 2,100 mg/day). A single milk sample was obtained approximately 10 to 15 hours after the last dose. Assuming a breast milk consumption of 150 mL/kg/day, the relative infant dose of gabapentin was estimated to be to mg/kg/day, which approximates % to % of the weight-adjusted maternal dose. At 2 to 3 weeks after delivery, 2 infants had detectable gabapentin plasma concentrations that were under the normal range of quantification, and 1 had an undetectable concentration. At 3 months, the gabapentin plasma concentration in another infant was under the normal range of quantification. No adverse effects were reported.