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. For many decades it has been given to: pregnant women, breastfeeding women, children, elderly patients, immune compromised patients and healthy persons. 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). Hydroxychloroquine is a prescription medication used to reduce pain and swelling caused by diseases of the immune system such as rheumatoid arthritis, juvenile arthritis, and systemic lupus erythematosus (SLE). The use of hydroxychloroquine in pregnancy without an increase in the rate of birth defects has been reported in the literature. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. HCQ is safe in pregnancy, well-tolerated, and costs only £0.10 per tablet in the UK. PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. UT Southwestern Medical Center, Division of Rheumatic Diseases, Dallas, Texas, Sign In to Email Alerts with your Email Address. that also can be used to prevent malaria. _____ Lately, we’ve been hearing a lot about using a drug called hydroxychloroquine in the fight against COVID-19. Peak milk level was reached 2 to 4 hours after dosing. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. As the authors point out, while whole blood testing may be more precise, serum levels may have the advantage of being less prone to confounding by cytopenias11. Centers for Disease Control "Guidelines for Treatment of Malaria in the United States. We comply with the HONcode standard for trustworthy health information -, Hydroxychloroquine use while Breastfeeding. 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). pregnant women and nursing mothers. Further studies into the pharmacokinetics of HCQ in the pregnant and nonpregnant state will also be important. In patients with SLE, disease activity was assessed by physician’s global assessment (PGA); SLE Disease Activity Index (SLEDAI) scores; and C3, C4, and dsDNA levels. Hydroxychloroquine is used to treat lupus and rheumatoid arthritis in pregnancy. 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. Costedoat-Chalumeau, et al were among the first to show that HCQ concentration could predict disease activity, with whole blood drug levels of > 1000 ng/ml having a high negative predictive value of flare9. Primary outcome for this study was neonatal gestational age. This medication belongs to a group of drugs called DMARDs (disease modifying antirheumatic drugs) which work by suppressing the excessive activity of the immune system. Learn about side effects, warnings, dosage, and more. These drugs may also have adverse pharmacological effects. Enter multiple addresses on separate lines or separate them with commas. A pregnancy was considered unexposed to HCQ if the drug was never taken or was discontinued before 10 weeks of gestation. HCQ appears more promising than chloroquine due to its greater effectiveness against SARS-CoV-2 … Flash electroretinograms performed on the infants were normal. Note: The Pregistry website includes expert reports on more than 2000 medications, 300 diseases, and 150 common exposures during pregnancy and lactation. ([2019, Dec 11]): "Product Information. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Alternatively, AZA itself could contribute to preterm and lower birth weights12. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. According to author estimation, the 2 infants would receive 0.06 and 0.2 mg/kg/day. PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Hydroxychloroquine may benefit pregnancies by reducing active disease of lupus. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). The guideline committee recommends that all patients … According to author estimation, a fully breastfed infant would receive 1 mg of parent drug and 0.066 mg of desethylchloroquine per day.At 7 time points between 0 and 18 hours after dosing, 13 women who were on long-term therapy donated milk samples. 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. According to author estimation, the infant would receive 0.11 mg/kg/day or about 2% of the mother's weight-adjusted dose. A: Generally acceptable. OBJECTIVE: To determine the safety for both mother and fetus of antimalarial drugs, i.e., chloroquine and hydroxychloroquine, in pregnant patients with lupus who continued antimalarial drugs throughout pregnancy. Hydroxychloroquine crosses the placenta but is considered safe to use during pregnancy. Hydroxychloroquine (HCQ) is known to cross the placenta and is present in similar concentrations in blood from the umbilical cord and the mother (Arthritis Rheum. Hydroxychloroquine may benefit pregnancies by reducing active disease of lupus. BREAST FEEDING COMPATIBILITY. Controlled studies in pregnant women show no evidence of fetal risk. It is available in tablets of 155mg base (200mg salt). 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) decreases flares and neonatal lupus syndrome. These results expand on previous findings while providing reassurance regarding the current guideline recommendations. Hydroxychloroquine (Plaquenil) and prednisone are considered safe during pregnancy. before traveling to the area where malaria transmission occurs. of botulinum toxin, which can have decreased efficacy if taken with hydroxychloroquine. It is available in the United States by prescription only. There are no controlled data in human pregnancy; however, a moderate amount of data on pregnant women (between 300 and 1000 pregnancy outcomes), including prospective studies in long-term use with large exposure, have not shown a significant increase in risk of congenital malformations or poor pregnancy outcomes.Therapeutic doses of 4-aminoquinolines have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages, and abnormal retinal pigmentation.According to the US CDC, this drug is a recommended agent for the treatment of chloroquine-sensitive malaria species during pregnancy; it is also recommended as an alternative for malaria prophylaxis during pregnancy for women traveling to areas where chloroquine-resistant Plasmodium falciparum has not been reported.Malaria in pregnant women increases the risk for adverse pregnancy outcomes, including prematurity, spontaneous abortion, and stillbirth. Anti-malarial drugs (hydroxychloroquine, chloroquine) are considered pregnancy category C drugs. A team of scientists from Japan has identified the approved anti-material drug, mefloquine, as a potential candidate to treat severe acute respiratory syndrome coronavirus 2 (SARS-CoV … 1,2 This low disease activity may have diluted the authors’ findings — HCQ level may have a larger effect in those patients with more active disease. Rationale . 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. Background/Purpose: Chloroquine (CQ) and Hydroxychloroquine (HCQ) have been used for years during pregnancy for multiple indications (malaria prevention, autoimmune disorders, etc.…). However, current management does not prevent all maternal, foetal and neonatal complications of APS. Thank you for your interest in spreading the word about The Journal of Rheumatology. The authors concluded that the benefits of breastfeeding outweighed the risk of this drug. (hydroxychloroquine)." The authors found significant intrasubject variability in serum HCQ during pregnancy11. ([2019, Jul 1]): Centers for Disease Control and Prevention "Treatment of Malaria: Guidelines For Clinicians (United States) Available from: URL: https://www.cdc.gov/malaria/diagnosis_treatment/clinicians1.html." Abstract. 292 Hydroxychloroquine does appear in breast milk, but the amount ingested per day by the breast-feeding infant would be very low. Guideline 5.3.2. Although the authors found a statistically significant relationship between HCQ levels and disease activity as measured by the PGA, the r2 of 0.07 reflects a nonlinear relationship. 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. 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. It should be noted that 4-aminoquinolines in therapeutic doses have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation. To the Editor.— In their excellent review article Tanenbaum and Tuffanelli 1 mention pregnancy as a contraindication to the use of chloroquine phosphate. Embryonic deaths and ocular malformations in the offspring have been reported when pregnant rats received large doses of chloroquine. 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. Plaquenil (R). National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006). The use of hydroxychloroquine in pregnancy without an increase in the rate of birth defects has been reported in the literature. Talk to your healthcare provider about the risks and benefits of using hydroxychloroquine during pregnancy (see Plaquenil and Pregnancy for more information). Hydroxychloroquine (Plaquenil) is used to treat malaria, lupus, and rheumatoid arthritis. 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 … METHODS: We document 9 pregnancies in 8 patients with lupus, all of whom took hydroxychloroquine (Plaquenil) throughout pregnancy. View chapter Purchase book. 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. It is sold under the brand name Plaquenil and it is also sold as a generic medicine. It is generally recommended for pregnant patients with an autoimmune disease. Hydroxychloroquine is also known as: Plaquenil, Quineprox. In the non-SLE patients, disease activity was measured by PGA on a visual analog scale ranging from 0 mm (no disease activity) to 100 mm (highest disease activity), with high disease activity defined as > 25 mm. Twenty-eight patients had SLE, 7 had rheumatoid arthritis or juvenile idiopathic arthritis, 5 had connective tissue disease, and the remaining 10 had other rheumatic and autoimmune disorders. Nonetheless, the evaluation of HCQ level during pregnancy could provide valuable information for disease management. We studied whether HCQ was associated with lower odds of preeclampsia and preterm delivery in SLE … Hydroxychloroquine and prednisone are considered safe during pregnancy. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Hydroxychloroquine is usually considered a pregnancy Category C medication. ([2019, Oct 1]): Centers for Disease Control and Prevention "Travel-Related Infectious Diseases. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Available from: URL: https://www.cdc.gov/malaria/resources/pdf/Malaria_Treatment_Table_120419.pdf." Hydroxychloroquine is usually available as the sulfate salt with hydroxychloroquine constituting about 75% of the labeled dose of hydroxychloroquine sulfate. Surprisingly, mean birth weight was the lowest in the group with optimal therapeutic levels of HCQ. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Talk to your healthcare provider about the risks and benefits of using hydroxychloroquine during pregnancy (see Plaquenil and Pregnancy for more information). HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Data are limited regarding the use of hydroxychloroquine during pregnancy. Objective. Maternal Levels.In a patient beginning therapy with 200 mg of hydroxychloroquine (sal… This study is a good start in understanding the relationship between HCQ levels, disease activity, and pregnancy outcome11, and suggests that maybe we ought to be focusing on drug levels rather than the dose of HCQ in our patients with SLE, whether pregnant or not. It has a half-life of over a month. The finding that nontherapeutic levels of HCQ were associated with a higher frequency of lower gestational age and more preterm delivery supports the authors’ conclusion that targeting strategies to improve HCQ adherence in pregnancy may improve outcome, although the lack of linear correlation between HCQ level and gestational age suggests that this relationship is complex. Hydroxychloroquine is usually considered a pregnancy Category C medication. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. Hydroxychloroquine Sulfate (hydroxychloroquine)." Stopping antimalarial drugs during pregnancy therefore not only puts the mother's health at risk but can also compromise the outcome of pregnancy. Available from: URL: https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/malaria." In a case series, 13 mothers taking 200 mg/day (as sulfate) breastfed their infants for an average of 2.8 months (range: 1 to 6 months); no infant had evidence of retinal, motor, or growth abnormalities during 12 months of follow-up. We do not capture any email address. Pregnancy: Hydroxychloroquine crosses the placenta. Importantly, whatever metric is used to determine HCQ adherence, many of our patients with SLE remain undertreated, and this could affect both disease activity and pregnancy outcome. Hydroxychloroquine in particular is associated with improved obstetric outcomes in SLE [9]. In animal studies on Plaquenil (hydroxychloroquine) and pregnancy, the medication crossed the placenta and accumulated in the eyes of the fetus when it was given to pregnant animals. Additional data assessed included the mother's age at the time of birth, mother's race/ethnicity, maternal diagnosis at the time of subsequent pregnancy, and anti-SSA/Ro-SSB/La antibody status. 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. 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. 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 … In 1 study, daily drug exposures to infants from breast milk were estimated to be less than 2% of the maternal dose (after adjusting for body weight).Infants exposed to this drug during breastfeeding receive only small amounts of the drug. Women with rheumatic diseases, including inflammatory arthritis and systemic lupus erythematosus (SLE), fare better in pregnancy when their disease is under good control1,2. 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 (HCQ) has been FDA approved for over 65 years and has been used billions of times throughout the entire world without restriction. Some studies have not been clear about the salt form and dosage of the products being taken and others have sampled milk after only a few doses before steady state was reached. Feldman, et al used claims data to show that 79% of nonpregnant patients with SLE are nonadherent7. These flaws make interpretation of some of the data difficult. 299 Hydroxychloroquine does appear in breast milk, but the amount ingested per day by a breastfeeding infant would be very low. This is Issue 45 in CLI’s On Point Series. In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Select one or more newsletters to continue. HCQ levels were categorized as nontherapeutic (< 100 ng/ml) or therapeutic (> 100 ng/ml). Caution is recommended; benefit to mother should outweigh risk to the infant.-According to some experts: Use is considered acceptable.Excreted into human milk: Yes (small amounts)Comments:-Infants are extremely sensitive to the toxic effects of 4-aminoquinolines.-When used for malaria prophylaxis, the amount in breast milk is too small to cause harmful effects in the nursing infant but is insufficient to confer any benefit on the infant; the breastfed infant will require separate chemoprophylaxis.-Very limited data available regarding the safety in breastfed infants during long-term maternal therapy. However, several studies of the medication have not shown any increase in the rates of adverse effects for mother or baby. It is generally recommended for pregnant patients with an autoimmune disease. Cerner Multum, Inc. "Australian Product Information." An abstract reported 16 infants breastfed for 1 to 19 months and followed up at an average of 24 months (range: 1 to 86 months) with no evidence of visual or hearing deficits. But these studies have not provided overwhelming evidence proving the safety of this agent in pregnancy, Jean-Charles Piette, M.D., said at an international conference on cutaneous lupus … 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. O 0, Cerner Multum, Inc. "UK Summary of Product Characteristics." 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. 2002;46:1123–4). See references. 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. Data are limited regarding the use of hydroxychloroquine during pregnancy. A: Generally acceptable. This study was unable to establish a statistically significant relationship between serum level of HCQ and disease activity. Malaria. Although human studies are lacking, available evidence suggests a relatively low risk to the fetus. In support of this approach, a survey of North American rheumatologists found that over 69% of rheumatologists continued HCQ in their pregnant patients6. Five mothers took hydroxychloroquine 200 mg daily during pregnancy and breastfeeding, one for 30 months. The role of hydroxychloroquine (HCQ) for achieving this control is now recognized. The relative merits of whole blood versus serum measurement of HCQ are unknown. The paradox that high serum levels > 500 ng/ml were likewise associated with both poor pregnancy outcome and higher disease activity remains confusing. Therapy may include low dose prednisolone [2], azathioprine [5], and /or hydroxychloroquine [6 - 8] as these have proved safe and efficacious in pregnancy [5]. The latter category was further divided into suboptimal therapeutic levels, defined as drug level of 100 ng/ml–500 ng/ml, and optimal therapeutic levels, defined as drug level > 500 ng/ml. A study of women with aPL who were taking hydroxychloroquine (HCQ) during pregnancy to treat lupus found that women taking HCQ had a better pregnancy outcome compared to women who do not take it, with fewer miscarriages and preterm births and a higher live birth rate. In the non-SLE patient group, neither disease activity nor pregnancy outcome was related to HCQ levels; however, the numbers of subjects in each diagnostic subcategory were so small that no definitive conclusions could be drawn. Hydroxychloroquine may also reduce the chance for a baby to be born with a specific heart conduction problem, called congenital heart block. OBJECTIVE: Systemic lupus erythematosus (SLE) increases the risk of complications in pregnancy. Who should not take hydroxychloroquine? Hydroxychloroquine crosses the placenta, but is considered safe to use during pregnancy. 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. We recommend that all women with lupus should be advised to take hydroxychloroquine in pregnancy unless it is contraindicated (1C). 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. Prasco Laboratories, Cincinnati, OH. In patients with SLE, neither the SLEDAI nor serum markers of SLE disease activity correlated with HCQ levels. 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. Both adults and children should take one dose of hydroxychloroquine per week starting at least 1 week . The use of hydroxychloroquine (HCQ) in pregnancy remains controversial. This means that it may not be safe for use during pregnancy, although the full risks are not known. Note: Doses are expressed in terms of hydroxychloroquine base: 400-mg tablet = 310-mg base; 800-mg tablet = 620-mg base Acute Malaria Adult: PO 620-mg base followed by 310-mg base at 6, 18, and 24 h Child: PO 10-mg base/kg, then 5-mg base/kg at 6, 18, and 24 h Malaria Suppression Other uses include treatment of rheumatoid arthritis, lupus, and porphyria cutanea tarda. This use has shown that HCQ is very safe in pregnancy. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Comparing these approaches head to head may clarify this point. 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. Although some providers are already … use of hydroxychloroquine ( HCQ ) in unless! Mothers were 344 and 1424 mcg/L at unspecified times after a dose [ 2019, Oct 1 ] ) centers... Related these levels to disease activity Score in 28 Joints–Gamma-glutamyl Transferase use improve disease. Number of studies using hydroxychloroquine during pregnancy itself could contribute to preterm and lower birth weights12 evidence... After dosing 37 weeks ) and prednisone are considered pregnancy category: D US FDA category... Drug should not be safe for use in men only is also presented for information purposes.... 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