7 Interactions found for:

The following applies to the ingredients: Aspirin

Professional Content

100 mg/day or less: Use with caution
Greater than 100 mg/day: NSAIDs should be avoided at 20 weeks gestation and later

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-Guidelines recommend low-dose aspirin prophylaxis (e.g., 81 mg/day) in women at high risk of preeclampsia; initiation should be between 12- and 28-weeks gestation (optimally before 16 weeks) and continued until delivery; the use aspirin at 81 mg/day dose for certain pregnancy-related conditions at any point in pregnancy is an exception to the FDA recommendations to avoid use of NSAIDs in pregnancy at 20 weeks or later.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.

In animals, prostaglandin synthesis inhibitors have been shown to increase pre and post-implantation loss and embryo-fetal lethality. Epidemiologic studies suggest increased risk of miscarriage, cardiac malformations, and gastroschisis when used early in pregnancy; the absolute risk of cardiovascular malformations increased from less than 1% to up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

Aspirin (acetylsalicylic acid) is a NSAID that inhibits cyclooxygenase (COX) isoenzymes 1 and 2. The effect on COX isoenzymes is dose-dependent with lower doses (60 to 150 mg) inhibiting platelet synthesis while higher doses results in inhibition of both COX-1 and COX-2 blocking all prostaglandin production. Low-dose aspirin has been used during pregnancy to prevent or delay the onset of preeclampsia. Daily low-dose aspirin has been shown to be associated with a low likelihood of serious maternal, or fetal complications. Guidelines should be consulted for specific use.

During the third trimester of pregnancy, administration of COX-1 and COX-2 blocking nonsteroidal anti-inflammatory drugs (NSAIDs) may cause premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, pulmonary hypertension, and prolongation of bleeding time. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later; the use aspirin at 81 mg/day dose for certain pregnancy-related conditions at any point in pregnancy is an exception. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

Administration during labor and delivery is not recommended as the onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child.

A study of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Semaglutide (found in Ozempic)

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Benefit should outweigh risk

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other maternal or fetal outcomes; based on animal data, there may be potential risks to the fetus from exposure during pregnancy. Additionally weight loss offers no benefit to a pregnant patient and may cause fetal harm.

Comments:
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.
-When pregnancy is recognized for a women on Wegovy, this drug should be discontinued and the patient should be advised of the risk to a fetus.
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-A pregnancy registry has been created to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy; pregnant women exposed to Wegovy and healthcare providers are encourage to contact Novo Nordisk at 1-800-727-6500.

Studies in pregnant rats have shown embryofoetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at doses below the MRHD. In cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed at exposures of 10-fold or higher that of the MRHD. In rabbits and monkeys, these finding coincided with marked maternal body weight loss. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet has been shown to cross the placenta and reach fetal tissue in rats. Administration of SNAC to pregnant rats has shown an increase in number of stillbirths and a decrease in pup viability. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with pregestational diabetes and a HbA1c greater than 10, this risk has been reported as 20% to 25%.
-Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues during pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Aspirin

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-This drug appears compatible with breastfeeding for occasional use and in low doses for anti-thrombosis; however, repeated use in normal doses and long-term use, especially in high doses should be avoided.
-Breastfed infants should be monitored for hemolysis, prolonged bleeding time, and metabolic acidosis.

This drug is excreted in human milk in small amounts. Low dose aspirin (75 to 162 mg/day) is considered by many experts to be compatible with breastfeeding. Peak milk salicylate levels have been reported up to 9 hours after maternal dosing with peak levels generally occurring 2 to 6 hours after nursing. Large doses may result in rashes, platelet abnormalities, and bleeding in nursing infants. Long-term, high dose maternal use was associated with 1 case of metabolic acidosis in breastfed infant. The risk for Reye's syndrome in infants with viral infections is unknown.

The following applies to the ingredients: Semaglutide (found in Ozempic)

Professional Content

Oral Administration: Not recommended
Subcutaneous Administration: Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Oral tablets: Breastfeeding is not recommended with maternal use of the oral tablet due to the possible accumulation of the absorption enhancer (salcaprozate sodium) in breastfed infant; if therapy is necessary, the subcutaneous injection should be used.
-Subcutaneous injection: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Some authorities advise against semaglutide use during lactation as a risk to the breastfed child cannot be excluded.

Subcutaneous formulation: In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.

Oral Tablet: Salcaprozate sodium (SNAC) is present in the oral formulation as an absorption enhancer. SNAC and/or its metabolites have been found in concentrated quantities in the milk of lactating rats. There are no data in the presence of SNAC in human milk, however, the enzyme needed to clear SNAC (UGT2B7) is lower in infants compared to adults and therefore higher SNAC plasma levels may occur in breastfed infants. The potential for serious adverse reactions due to accumulation of SNAC are unknown.