Despite the recognition that HCQ is a key component of SLE disease management in both nonpregnant and pregnant patients, adherence to HCQ remains abysmally low. In one study, hydroxychloroquine concentrations ≤100 ng/mL correlated with increased disease activity and adverse maternal/fetal outcomes in women with SLE, but there was no … There is evidence that HCQ may be safe during pregnancy, with previous research finding no increased risk of, prematurity, fetal death, retinopathy, low birth weight, stillbirth, or congenital defects[2-4]. HCQ is safe in pregnancy, well-tolerated, and costs only £0.10 per tablet in the UK. Hydroxychloroquine (HCQ) is often needed to manage disease activity in systemic lupus erythematosus (SLE) during pregnancy. Hydroxychloroquine crosses the placenta but is considered safe to use during pregnancy. A pregnancy was considered unexposed to HCQ if the drug was never taken or was discontinued before 10 weeks of gestation. Who should not take hydroxychloroquine? Hydroxychloroquine is used to treat lupus and rheumatoid arthritis in pregnancy. [1,15] Another group of investigators have reported numerous infants whose mother took hydroxychloroquine during pregnancy and were breastfed during maternal hydroxychloroquine use. Select one or more newsletters to continue. Hydroxychloroquine is also known as: Plaquenil, Quineprox. These medications are not usually taken together. This is Issue 45 in CLI’s On Point Series. While there is evidence of risk for damage to the eye and ear, if the benefits of these drugs in controlling RA symptoms are judged to outweigh the risks, they may continue to be used during pregnancy. Pregnancy: Hydroxychloroquine crosses the placenta. Maternal Levels.In a patient beginning therapy with 200 mg of hydroxychloroquine (sal… In this issue of The Journal, Balevic, et al report on a single-center observational study of 50 pregnant patients with rheumatic disease who were prescribed HCQ11. Several studies demonstrate that patients with SLE who continue HCQ during pregnancy have decreased flares and improved pregnancy outcomes, including longer fetal gestation and infants with higher birth weight3,4. 299 Hydroxychloroquine does appear in breast milk, but the amount ingested per day by a breastfeeding infant would be very low. It has a half-life of over a month. The recent demonstration that HCQ passes across the placenta, with cord blood concentrations nearly identical to those found in maternal blood, emphasizes the need for … _____ Lately, we’ve been hearing a lot about using a drug called hydroxychloroquine in the fight against COVID-19. Some studies have not been clear regarding salt form and dose of the products used and others have sampled milk after only a few doses before steady state was reached, making interpretation of some of the data difficult.In a patient starting therapy with 200 mg (salt unspecified) twice a day, the highest milk level detected was 10.6 mcg/L from 3 to 12 hours after the fourth dose. Further studies into the pharmacokinetics of HCQ in the pregnant and nonpregnant state will also be important. Several studies demonstrate that patients with SLE who continue HCQ during pregnancy have decreased … I have been involved with this problem with one patient, a 23-year-old woman who was taking 200 mg/day of hydroxychloroquine sulfate during the first 16 weeks of pregnancy as a therapy for discoid lupus erythematosus. Available from: URL: https://www.cdc.gov/malaria/resources/pdf/Malaria_Treatment_Table_120419.pdf." Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of hydroxychloroquine may be altered in pregnant women; however, dosage adjustments are not needed (Balevic 2019b). HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. It is generally recommended for pregnant patients with an autoimmune disease. "Product Information. We comply with the HONcode standard for trustworthy health information -, Hydroxychloroquine use while Breastfeeding. Database search . Even if it is generally agreed that pregnancy per se increases disease activity in patients with SLE and that withdrawal of HCQ at the onset of pregnancy may result in exacerbation of SLE, use of HCQ during pregnancy has remained controversial for a long time. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. Available for Android and iOS devices. No ocular toxicity or growth abnormalities were found at 1-year follow-up of the infants.After 5 mothers took 200 mg/day during pregnancy and breastfeeding (1 for 30 months), flash electroretinograms performed on the infants were normal.A group of investigators have reported numerous infants whose mother took this drug during pregnancy and were breastfed during maternal use. Travel to malarious areas should be avoided during pregnancy; if this is not possible, women should receive effective prophylaxis.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. Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). However, in multiple studies, hydroxychloroquine use has not been associated with congenital disabilities, stillbirth, prematurity, low birth weight, fetal death, or retinopathy following maternal intake at recommended … However, several studies of the medication have not shown any increase in the rates of adverse effects for mother or baby. Doses (as sulfate) ranged from 200 mg once every 2 days to 200 mg twice a day, with most taking 200 mg once (24%) or twice (64%) a day; these doses are equivalent to 155 and 310 mg base. In a letter, they reported 8 breastfed infants followed up at 1, 6, and 12 months of age who had normal growth and development and who had thorough, normal eye examinations at 1 and 12 months of age. 1,2 Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). Hydroxychloroquine … This drug crosses the placenta. Abstract. Controlled studies in pregnant women show no evidence of fetal risk. Learn about side effects, warnings, dosage, and more. Introduction. PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Exercise caution when administering hydroxychloroquine to nursing women; When administered to nursing women, hydroxychloroquine is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines; Pregnancy Categories. This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. These paradoxical findings could reflect that the patients in the > 500 ng/ml group may have been sicker. Eighty-three percent of patients in this group compared to 12% in the suboptimal therapeutic group and 16.7% in the nontherapeutic groups were taking azathioprine (AZA), suggesting that these patients may have had disease that is more complex. Nonetheless, the evaluation of HCQ level during pregnancy could provide valuable information for disease management. Hydroxychloroquine does cross the placenta and is considered Category D in pregnancy (see DermNet NZ's pages on Safety of medicines taken during pregnancy and on Lactation and the skin). Stopping antimalarial drugs during pregnancy therefore not only puts the mother's health at risk but can also compromise the outcome of pregnancy. HCQ is considered a Category C medication, indicating that it remains unknown what effect the drug will have on the fetus. Objective: The use of hydroxychloroquine (HCQ) in pregnancy remains controversial. Stopping antimalarial drugs can precipitate disease flares of systemic lupus erythematosus (SLE), which are known to be detrimental to the outcome of pregnancy in patients with SLE. Among the SLE pregnancies, those with nontherapeutic levels of HCQ (< 100 ng/ml) had a higher frequency of infants with lower gestational age (p = 0.03); however, the authors were unable to demonstrate a linear association between HCQ serum level and gestational age. Alternatively, AZA itself could contribute to preterm and lower birth weights12. ([2019, Oct 1]): Centers for Disease Control and Prevention "Travel-Related Infectious Diseases. This study was unable to establish a statistically significant relationship between serum level of HCQ and disease activity. Too Little of a Good Thing: Hydroxychloroquine in Pregnancy, DOI: https://doi.org/10.3899/jrheum.181046, Influence of disease activity and medications on offspring birth weight, pre-eclampsia and preterm birth in systemic lupus erythematosus: a population based study, Rheumatoid arthritis and pregnancy: beyond smaller and preterm babies, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Feasibility of hydroxychloroquine adjuvant therapy in pregnant women with systemic lupus erythematosus, BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids, Survey of antimalarial use in lupus pregnancy and lactation, Medication nonadherence is associated with increased subsequent acute care utilization among Medicaid beneficiaries with systemic lupus erythematosus, Trends in use of hydroxychloroquine during pregnancy in systemic lupus erythematosus patients from 2001–2015, Low blood concentration of hydroxychloroquine is a marker for and predictor of disease exacerbations in patients with systemic lupus erythematosus, Hydroxychloroquine serum concentrations and flares of systemic lupus erythematosus: A longitudinal cohort analysis, Hydroxychloroquine levels throughout pregnancies complicated by rheumatic disease: implications for maternal and neonatal outcomes, Retardation of fetal growth in patients receiving immunosuppressive therapy, Relapsing Polychondritis and Large-vessel Vasculitis. It is available in the United States by prescription only. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. OBJECTIVE: Systemic lupus erythematosus (SLE) increases the risk of complications in pregnancy. Pregnancy and hydroxychloroquine. The authors found significant intrasubject variability in serum HCQ during pregnancy11. The authors also found a higher frequency of infants preterm born to mothers with a serum level of HCQ < 100 ng/ml compared to those with therapeutic levels of HCQ (> 100 ng/ml; p = 0.01)11. These authors also reported 2 other women with milk drug levels of 1131 and 1392 mcg/L at unreported times after unspecified doses (presumably 200 to 400 mg/day); according to author estimation, their 2 infants would receive no more than 0.2 mg/kg/day via breast milk.Numerous milk samples were collected from 6 women using 400 mg (n=5) or 200 mg (n=1) per day; the milk level averaged 376 mcg/L (range: 20 to 1463 mcg/L) as parent drug and 36 mcg/L (range; 11 to 111 mcg/L) as desethylchloroquine. It appears the 8 infants reported in the letter were included among the 13 infants in the case series, but it is unclear whether the 16 infants reported in the abstract were part of the case series. However, current management does not prevent all maternal, foetal and neonatal complications of APS. To view this report as a PDF, see: On Point 45 Hydroxychloroquine Use During Pregnancy In recent weeks, hydroxychloroquine (HCQ) has received significant media attention because of initial reports that suggest that it could be an effective treatment for the highly infectious respiratory disease, COVID-19, caused by the novel coronavirus, SARS-CoV-2. The optimal duration of therapy to achieve steady state, timing of blood draw in relation to dose administration, changes in pharmacokinetics because of pregnancy, and disease factors still represent unresolved issues. High disease activity for patients with SLE was defined as a PGA > 1.0. Data are limited regarding the use of hydroxychloroquine during pregnancy. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. While there is evidence of risk for damage to the eye and ear, if the benefits of these drugs in controlling RA symptoms are judged to outweigh the risks, … Hydroxychloroquine and prednisone are considered safe during pregnancy. BREAST FEEDING COMPATIBILITY. The change in recommendations is based on the recent Food and Drug Administration (FDA) re-categorization of mefloquine from a pregnancy category C drug to category B, based on their review of the published data on mefloquine use during pregnancy. The pregnancy category and safety statement for some medicines that are no longer registered for use in Australia are presented in this database for information only. HCQ drug level during pregnancy is likely to be even more unpredictable given the increased volume of distribution of the drug and the increase in the body mass index of pregnant women. Flash electroretinograms performed on the infants were normal. It is generally recommended for pregnant patients with an autoimmune disease. Hydroxychloroquine levels in the two mothers were 344 and 1424 mcg/L at unspecified times after a dose. Thank you for your interest in spreading the word about The Journal of Rheumatology. This systematic review contains a meta-analysis of the available clinical studies investigating the use of HCQ during pregnancy and will focus on the risk of congenital defects, number of live births, spontaneous abortions, fetal deaths and pre-maturity in fetuses born to women taking HCQ. Average milk levels were dose related and ranged from 0.4 to 1.2 mg/L (mean: 0.7 mg/L) with 200 mg once a day and 0.5 to 3.7 mg/L (mean: 1.4 mg/L) with 200 mg twice a day. In patients with SLE, neither the SLEDAI nor serum markers of SLE disease activity correlated with HCQ levels. Thus, low adherence to HCQ confounds conclusions regarding this drug’s effect on disease control and pregnancy outcome in SLE. Hydroxychloroquine may also reduce the chance for a baby to be born with a specific heart conduction problem, called congenital heart block. The Pregnancy subsection (8.1) includes information for a pregnancy exposure registry for the drug when one is available. Additionally, women need to know which medications should be established pre-pregnancy (for example, hydroxychloroquine), and ensure that their blood pressure is controlled. Hydroxychloroquine (HCQ) is often needed to manage disease activity in systemic lupus erythematosus (SLE) during pregnancy. Anti-malarial drugs (hydroxychloroquine, chloroquine) are considered pregnancy category C drugs. The role of hydroxychloroquine (HCQ) for achieving this control is now recognized. The recent demonstration that HCQ passes across the placenta, with cord blood concentrations nearly identical to those found in maternal blood, emphasizes the need for careful evaluation of pregnancies in women receiving HCQ. Two women who had taken hydroxychloroquine 200 mg (probably sulfate equivalent to 150 mg of base) once or twice daily (the report is unclear) before and during pregnancy had milk levels measured after delivery. The purpose of this study was to examine lupus activity and pregnancy outcomes in women with SLE treated or not treated with HCQ during pregnancy. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. Objective. 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