THIS MEDICATION IS UNLIKELY TO CAUSE HARM TO YOUR BABY:
Although there is limited information available on the safety of chloroquine and hydroxychloroquine in human pregnancy, both antimalarial medications are considered compatible with pregnancy. There is no evidence in human studies showing an increased risk of birth defects or eye toxicity associated with the use of these medications during pregnancy. Chloroquine and hydroxychloroquine have also been classified as compatible with breastfeeding by the American Academy of Pediatrics. It is important to only use these medications during pregnancy and breastfeeding when required.
What is Chloroquine/Hydroxychloroquine?
Chloroquine and hydroxychloroquine are antimalarial medications. Chloroquine is available as a generic medication in the United States. It is typically administered as a weekly dose after an initial dose as part of a combination of medications followed by doses at 6, 24, and 48 hours. Children require weight-based dosing. Malaria treatment may require a combination of chloroquine with one or more other medications. Chloroquine is available as an oral tablet and is only available by prescription from your doctor.
Hydroxychloroquine is a derivative of chloroquine which is considered slightly more potent than chloroquine. Hydroxychloroquine is available as a generic or brand name (Plaquenil™) medication. Children require weight-based hydroxychloroquine dosing. Hydroxychloroquine is typically administered as a daily dose for treatment of lupus and rheumatoid arthritis, but it is administered weekly for prevention of malaria. To treat malaria, hydroxychloroquine is given as an initial dose as part of a combination of medications followed by doses at 6, 24, and 48 hours for non-severe cases in individuals not receiving preventative chloroquine or hydroxychloroquine. Hydroxychloroquine is available as an oral tablet and is only available by prescription from your doctor.
What is Chloroquine/Hydroxychloroquine used to treat?
Chloroquine is used to treat malaria, and hydroxychloroquine is used to treat malaria as well as lupus and rheumatoid arthritis. Hydroxychloroquine is also used for multiple off-label indications. Malaria infections are mostly a concern in African countries, but they can carry significant risks to both mother and baby during pregnancy. Malaria during pregnancy can be associated with miscarriage, stillbirth, low birth weight, and prematurity.
*Chloroquine and hydroxychloroquine were given emergency use authorization by the US FDA in March/April 2020 to treat COVID-19; however, this authorization was revoked in June 2020 due to a lack of safety and efficacy data. Use of chloroquine or hydroxychloroquine to treat COVID-19 in pregnant women has not been well studied. The American College of Obstetricians and Gynecologists and the Centers for Disease Control and Prevention provide further information on diagnosis and treatment of COVID-19 in pregnant women.
You can find out more about malaria in pregnancy here. Additional information on the use of hydroxychloroquine to treat COVID-19 during pregnancy can be found here. You can find out more about rheumatoid arthritis during pregnancy here, and lupus during pregnancy here.
How does Chloroquine/Hydroxychloroquine work?
Chloroquine works by interfering with the DNA and RNA of the malaria parasite as well as hemoglobin use, growth, and the cell membrane of malaria parasites.
Hydroxychloroquine works by interfering with hemoglobin use and digestive functions of malaria parasites as well as inhibiting negative immune system reactions to the malaria parasite.
If I am taking Chloroquine/Hydroxychloroquine, can it harm my baby?
Pregnant women are encouraged to avoid travel to areas of the world where there is an increased risk of catching malaria. However, if travel is required, pregnant women should take precautions to prevent mosquito bites, such as using insect repellent, and should also receive malaria preventative medications such as chloroquine or hydroxychloroquine.
Chloroquine is used to prevent and treat malaria in pregnant women. The benefits to the mother are expected to outweigh any potential risk to the developing baby. However, due to unknown risks to the developing baby, chloroquine should only be used during pregnancy if required to treat or prevent malaria. Untreated malaria during pregnancy is associated with significant negative outcomes for the baby such as miscarriage, stillbirth, anemia, prematurity, low birth weight, and fetal distress. Infected and untreated mothers can also transmit malaria to their baby. Negative outcomes for pregnant women who remain untreated include respiratory distress, hemolysis, kidney failure, blood clotting, and low blood sugar. Plasmodium falciparum malaria in pregnant women is associated with fetal distress, uterine contractions, intrauterine growth restriction, and placental insufficiency. Transmission of malaria from mother to infant at birth can result in jaundice, fever, and liver/blood issues in babies.
Hydroxychloroquine can be used in pregnant women to prevent malaria; however, use of this medication for conditions such as lupus or rheumatoid arthritis may carry a higher risk to the developing baby. Untreated flare-ups of lupus or rheumatoid arthritis during pregnancy also have the potential to cause harm to both mother and baby.
Evidence from animal studies with Chloroquine/Hydroxychloroquine:
Chloroquine is associated with death and eye defects in rats given high doses (1000 mg/kg) of the medication. It is classified as an animal teratogen (causes malformation of developing offspring). In pregnant mice and monkeys exposed to chloroquine, the medication concentrated in the eyes of the developing babies.
Evidence for the risks of Chloroquine/Hydroxychloroquine in human babies:
Chloroquine crosses the placenta to reach the baby. Chloroquine has not been found to increase the risk of adverse events in the baby when used at low doses for malaria prevention. Case reports of infants exposed in utero to chloroquine have found no conclusive evidence that the medication is associated with an increased risk of birth defects. Studies have not identified an increase in miscarriages or birth defects with chloroquine use during pregnancy. Although animal studies suggest chloroquine can cause retinal toxicity in developing babies, no human studies have proven that there is an increased risk of this adverse event when the medication is used during pregnancy. There have been a few reports of blindness, deafness, and birth defects associated with chloroquine use to prevent malaria during pregnancy. A review including 12 studies found antimalarial use during pregnancy had a low or non-existent risk of eye toxicity. A study in 300 women in areas of Africa with malaria prevalence and who received chloroquine found a decreased risk of malaria transmission as well as decreased cases of the baby dying or having low birth weight.
The Centers for Disease Control and Prevention note that hydroxychloroquine can be used to prevent malaria in pregnant women when used at a dose of 400 mg/week, and this is not expected to cause harm to the baby. However, higher and more prolonged doses of hydroxychloroquine used for treatment of rheumatoid arthritis, lupus, or acute malaria infection have the possibility of increasing the risk of harm to the baby and retinal toxicity. Animal studies have shown the potential for retinal toxicity with chloroquine, but human studies have not confirmed the same risk of retinal toxicity with hydroxychloroquine. Hydroxychloroquine has not been associated with birth defects in the available studies. The Collaborative Perinatal Project reported no adverse effects on the baby with first trimester exposure to hydroxychloroquine. O
ne study in 23 women (27 pregnancies) followed infants for 3 years after in utero exposure to hydroxychloroquine in mothers with lupus during pregnancy, finding no adverse effects associated with the medication. Flare-ups of lupus during pregnancy posed a greater risk of danger to the developing baby. Studies assessing long-term infant development after in utero exposure to hydroxychloroquine have all shown normal development. An analysis of 8 studies in pregnant women exposed to hydroxychloroquine found no increased risk of birth defects, stillbirth, low birth weight, or prematurity. A review of clinical trials published through 2014 found hydroxychloroquine exposure in pregnancy was not associated with an increased risk of birth defects, miscarriage, premature death, or fewer live births in pregnant women with autoimmune conditions.
Bottom line: Chloroquine and hydroxychloroquine can be used to prevent and treat malaria during pregnancy. These medications have also been used to treat and prevent flare-ups of autoimmune conditions during pregnancy. Animal studies have shown the potential for retinal toxicity with chloroquine, but human studies have not confirmed the same risk of retinal toxicity with chloroquine or hydroxychloroquine. A few studies have found an increased risk of birth defects with use of either of these antimalarial medications during pregnancy.
If I am taking Chloroquine/Hydroxychloroquine and become pregnant, what should I do?
If you are taking chloroquine or hydroxychloroquine and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby. Your doctor may counsel you on the risks associated with the use of these medications during pregnancy.
If I am taking Chloroquine/Hydroxychloroquine, can I safely breastfeed my baby?
Chloroquine and hydroxychloroquine are expected to be excreted into breast milk. The American Academy of Pediatrics classifies chloroquine and hydroxychloroquine as compatible with breastfeeding. No adverse events have been reported in nursing infants exposed to chloroquine or hydroxychloroquine. Although the amount of chloroquine or hydroxychloroquine reaching the nursing infant from a mother taking these medications is not anticipated to be harmful, they do not protect the infant against malaria. Limited information exists on the safety of daily use of chloroquine so hydroxychloroquine may be recommended instead. Once weekly doses of hydroxychloroquine used for malaria prevention are not expected to result in significant accumulation or toxicity for the nursing infant. However, daily use of hydroxychloroquine may be associated with a greater risk of toxicity in nursing infants so caution is advised. The follow-up of infants exposed to hydroxychloroquine while nursing has found no evidence of adverse effects on growth, vision, or hearing at 1 year of age. Similarly, maternal doses of chloroquine used for prevention and treatment of malaria are not expected to pose a risk of harm to nursing infants; however, the manufacturer of chloroquine recommends discontinuation of either the medication or breastfeeding to prevent possible adverse effects. Nursing infants exposed to chloroquine should be monitored for signs of hemolysis or jaundice.
Bottom line: Chloroquine and hydroxychloroquine are expected to pass into breast milk. No adverse events have been reported in nursing infants exposed to chloroquine or hydroxychloroquine. Similarly, maternal doses of chloroquine or hydroxychloroquine used for prevention and treatment of malaria are not expected to pose a risk of harm to nursing infants. Caution is recommended if using these antimalarial medications while breastfeeding a baby.
If I am taking Chloroquine/Hydroxychloroquine, will it be more difficult to get pregnant?
Doses of chloroquine 5 mg/day given to male rats decreased testosterone levels and the weight of the testes and prostate. In female rats who mated with male rats exposed to chloroquine, there was a decreased number of offspring.
If I am taking Chloroquine/Hydroxychloroquine, what should I know?
Chloroquine and hydroxychloroquine are considered compatible with pregnancy. There is no evidence in human studies showing an increased risk of birth defects or eye toxicity associated with the use of these medications during pregnancy. Chloroquine and hydroxychloroquine have also been classified as compatible with breastfeeding by the American Academy of Pediatrics. It is important to only use these medications during pregnancy and breastfeeding when required.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of chloroquine or hydroxychloroquine during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about malaria here, rheumatoid arthritis here, lupus here, and reports about the individual medications used to treat immune disorders here. Additional information can also be found in the resources below.
For more information about Chloroquine/Hydroxychloroquine during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
World Health Organization: Malaria in pregnant women
U.S. National Library of Medicine: LACTMED: CHLOROQUINE/HYDROXYCHLOROQUINE