Are there any special considerations for the use of oral steroids in pregnant patients?

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 4, 2024.

Pregnancy If systemic corticosteroids such as prednisone must be used during pregnancy, the potential risks should be discussed with the patient. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Based on findings from human and animal studies, corticosteroids can cause fetal harm when administered to a pregnant woman. Published epidemiological studies suggest a small but inconsistent increased risk of orofacial clefts with use of systemic corticosteroids during the first trimester. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of systemic corticosteroids during pregnancy; however, the underlying maternal condition may also contribute to these risks. There are no adequate and well-controlled studies in pregnant women.

Contraindications And Precautions If systemic corticosteroids such as sterapred ds must be used during pregnancy, the potential risks should be discussed with the patient. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Based on findings from human and animal studies, corticosteroids can cause fetal harm when administered to a pregnant woman. Published epidemiological studies suggest a small but inconsistent increased risk of orofacial clefts with use of systemic corticosteroids during the first trimester. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of systemic corticosteroids during pregnancy; however, the underlying maternal condition may also contribute to these risks. There are no adequate and well-controlled studies in pregnant women.

2.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 3, 2024.

Pregnancy Systemic oralone use should be approached with caution during pregnancy and should be used during pregnancy only when the anticipated benefit outweighs the potential fetal risk. Human and animal studies suggest that use of systemic corticosteroids during the first trimester of pregnancy is associated with an increased risk of orofacial clefts, intrauterine growth restriction and decreased birth weight. If systemic oralone must be used chronically during pregnancy, the potential risks should be discussed with the patient. Infants born to women receiving large doses of systemic corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency, and appropriate therapy should be initiated, if necessary. Caution is also recommended with the use of nasal oralone. Topical use of oralone during pregnancy should also be approached with caution. Topical corticosteroids, including oralone, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency topical agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. No studies have been conducted with suprachoroidal injection of oralone acetonide (Xipere) in pregnant patients. It is unknown if this route of administration could be associated with fetal risks; however, systemic exposure following suprachoroidal administration is negligible. Administer during pregnancy only if the potential benefit justifies the potential risk to the infant.

Contraindications And Precautions Systemic sp rx 228 use should be approached with caution during pregnancy and should be used during pregnancy only when the anticipated benefit outweighs the potential fetal risk. Human and animal studies suggest that use of systemic corticosteroids during the first trimester of pregnancy is associated with an increased risk of orofacial clefts, intrauterine growth restriction and decreased birth weight. If systemic sp rx 228 must be used chronically during pregnancy, the potential risks should be discussed with the patient. Infants born to women receiving large doses of systemic corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency, and appropriate therapy should be initiated, if necessary. Caution is also recommended with the use of nasal sp rx 228. Topical use of sp rx 228 during pregnancy should also be approached with caution. Topical corticosteroids, including sp rx 228, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency topical agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. No studies have been conducted with suprachoroidal injection of sp rx 228 acetonide (Xipere) in pregnant patients. It is unknown if this route of administration could be associated with fetal risks; however, systemic exposure following suprachoroidal administration is negligible.

3.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 4, 2024.

Contraindications And Precautions Millipred Dp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on findings from human and animal studies, corticosteroids can cause fetal harm when administered to a pregnant woman. Published epidemiological studies suggest a small but inconsistent increased risk of orofacial clefts with the systemic use of corticosteroids during the first trimester. Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of corticosteroids during pregnancy; however, the underlying maternal condition may also contribute to these risks. Published animal studies show millipred dp to be teratogenic in rats, rabbits, hamsters, and mice with an increased incidence of cleft palate in offspring. Advise a pregnant woman about the reproductive risk and the potential harm to a fetus. Neonates born to pregnant women who have received corticosteroids should be carefully monitored for signs and symptoms of hypoadrenalism, and appropriate therapy should be initiated, if necessary. Ophthalmic millipred dp and other ocular corticosteroids were applied to both eyes of pregnant mice (5 times per day on days 10 through 13 of gestation); a significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice.

4.

Elsevier ClinicalKey Clinical Overview

Treatment In general, oral steroids are contraindicated due to adverse effects on fetus, especially during the first trimester. A meta-analysis of 10 studies analyzing the association between oral steroids and adverse fetal outcomes was significant for an increased risk in cleft palate. Topical nasal decongestants which provide rapid symptomatic relief of nasal congestion have fallen out of favor in the general population due to the known side effect of rhinitis medicamentosa that can occur with prolonged use A retrospective analysis of more than 4000 women who used oral decongestants both early and later in pregnancy found no increase in the risk of congenital malformations, lower rate of preterm births, and/or low birth weight compared with the general popuation. Use of oral decongestants is not known to cause rhinitis medicamentosa, but there is mixed data surrounding their safety in pregnancy Nasal anticholinergic medications such as ipratropium are commonly prescribed for vasomotor rhinitis which presents with anterior watery rhinorrhea. There are no studies specifically evaluating the safety of nasal ipratropium in pregnancy. However, ipratropium is commonly used via the inhaled route for the treatment of asthma exacerbations during pregnancy and is considered FDA class B Immunotherapy as it pertains to allergic rhinitis refers to exposing patients to immunologically verified allergens in a controlled and graded fashion to decrease the allergic response to those triggers Continuing immunotherapy during pregnancy at the same dose as what the mother had been taking before pregnancy has been evaluated to be safe in multiple retrospective reviews However, initiating new immunotherapy or increasing the dose of ongoing immunotherapy carries a rare but possible risk of systemic allergic reactions including anaphylaxis. Therefore, escalating doses of allergen during pregnancy is contraindicated, given the greater risk to both mother and fetus

5.

Food and Drug Administration (DailyMed).

Publish date: February 4, 2024.

Precautions Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids. When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., diuretics, amphotericin-B), patients should be observed closely for development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued. Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Corticosteroids may suppress reactions to skin tests. Pregnancy Teratogenic Effects Pregnancy Category C. Prednisolone has been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which prednisolone has been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well controlled studies in pregnant women. PEDIAPRED (prednisolone sodium phosphate)®\ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

6.

Food and Drug Administration (DailyMed).

Publish date: October 3, 2022.

Pregnancy Usage in pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. Corticosteroids have been shown to impair fertility in male rats. Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids. The use of hydrocortisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

7.

Food and Drug Administration (DailyMed).

Publish date: May 1, 2021.

Warnings And Cautions Intraocular pressure may become elevated in some individuals. If corticosteroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Corticosteroids should not be used in active ocular herpes simplex. 5.8 Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease. While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. 5.9 Effect on Growth and Development Long-term use of corticosteroids can have negative effects on growth and development in children. Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully monitored. 5.10 Embryo-Fetal Toxicity RAYOS (prednisone) can cause fetal harm when administered to a pregnant woman. Human studies suggest a small but inconsistent increased risk of orofacial clefts with use of corticosteroids during the first trimester of pregnancy. Published animal studies show prednisolone to be teratogenic in rats, rabbits, hamsters, and mice with increased incidence of cleft palate in offspring. Intrauterine growth restriction and decreased birth weight have also been reported with corticosteroid use during pregnancy, however, the underlying maternal condition may also contribute to these risks. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, advise the patient about the potential harm to the fetus [see Use in Specific Populations (8.1) ].

8.

Nguyen GC, Seow CH, Maxwell C, et al. Gastroenterology. 2016;150(3):734-757.e1. doi:10.1053/j.gastro.2015.12.003.

Publish date: March 2, 2016.

American Gastroenterological Association Institute technical review on the use of thiopurines, methotrexate, and anti-TNF-alpha biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. recommend the use of corticosteroids or anti-TNF therapy in nonpregnant patients who fail to respond to 5-ASA or thiopurine therapy. Anti-TNF therapy is also recommended for maintenance; however, corticosteroids are not. A meta-analysis showed that corticosteroids were effective in inducing remission in UC and may be of benefit in CD. In a small series of pregnant women who were hospitalized with a relapse of IBD, 15 of 18 patients (83%) had a clinical response to intravenous corticosteroid or intravenous cyclosporine therapy and avoided colectomy. In a small case-control study, there were significantly increased risks of preterm birth and LBW associated with exposure to corticosteroids; however, this was confounded by the fact that these patients were hospitalized for severe disease activity. Short-acting prednisone, prednisolone, and methylprednisolone are more efficiently metabolized by the placenta and may result in lower fetal exposure than the longer-acting dexamethasone and betamethasone. In addition, budesonide is a systemic corticosteroid that has high first-pass metabolism. Its use has been reported in patients with CD during pregnancy and may be preferred for the treatment of mild to moderate disease because of low corticosteroid exposure to the fetus. The consensus group concluded that, given the low risk of adverse pregnancy outcomes associated with corticosteroid or anti-TNF therapy and the increased risk of adverse outcomes associated with active disease, the benefits of achieving remission with these agents would likely outweigh the potential risks. The choice of either corticosteroid or anti-TNF therapy should be individualized and consider the severity of disease activity (Figure 2). Although the quality of evidence for the efficacy and safety of corticosteroids is weaker than that for anti-TNF therapy, in clinical practice, corticosteroid therapy may induce remission more rapidly than anti-TNF therapy.