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Doxylamine succinate-pyridoxine hydrochloride (Diclegis®|Diclectin®)
- Friday, 01 December 2017
In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. This sheet talks about whether exposure to the combination of doxylamine succinate and pyridoxine hydrochloride may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.
What is doxylamine succinate-pyridoxine hydrochloride?
Doxylamine succinate is a medication that has been used as an antihistamine and as a sleeping aid. Antihistamines lessen the symptoms of allergic reactions, insomnia (unable to sleep) and colds. Pyridoxine hydrochloride is a form of vitamin B6.
The combination of 10mg of doxylamine succinate and 10mg of pyridoxine hydrochloride is a medication used to treat nausea and vomiting of pregnancy (NVP), also called “morning sickness.” For more information on NVP, please see the MotherToBaby fact sheet Nausea and Vomiting of Pregnancy ( https://mothertobaby.org/fact-sheets/nausea-vomiting-pregnancy-nvp/pdf/ ).
In the United States, the combination of doxylamine and pyridoxine has been sold under the name Diclegis® since 2013. Many years ago, it was sold under the name Bendectin®. In Canada, it has been sold under the brand name Diclectin® since 1979.
Diclegis® and Diclectin® are delayed-release tablets available by prescription. Delayed-release means that the tablet coating prevents the ingredients from being absorbed too quickly by the body. For this reason, it is important to take the medication on a set schedule (not just as needed) in order to obtain the greatest benefit. Doxylamine succinate and/or pyridoxine hydrochloride may also be available as over-the-counter medicine (OTC).
Did the manufacturer stop making Bendectin® because it was unsafe?
No. Bendectin® was used by over 33 million women worldwide, from 1956, when it was first approved by the U.S. FDA, through 1983. In the 1970s, lawsuits filed against the manufacturer claimed that the use of Bendectin® in pregnancy caused babies to be born with birth defects. However, the scientific evidence did not support these claims. In 1983, Bendectin® production was stopped because of the increased costs of these lawsuits. The FDA released a statement in 1983 and again in 1999 emphasizing that the withdrawal was not related to safety. In 2013 the FDA classified Diclegis® as not having risk to the fetus and approved the use of Diclegis® for treatment of NVP.
Is it okay to use doxylamine succinate-pyridoxine hydrochloride during pregnancy?
Yes. Doxylamine succinate-pyridoxine hydrochloride is well studied in its use to treat NVP. Studies totaling hundreds of thousands of exposed pregnant women have not found its use during pregnancy to increase the chance of birth defects or other adverse pregnancy outcomes. The combination of doxylamine succinate and pyridoxine hydrochloride is currently recommended as a first-line treatment for NVP by the American Congress of Obstetricians and Gynecologists (ACOG) and by several medical organizations in Canada. In addition, keeping your NVP under control might help to keep you out of the hospital for dehydration caused by vomiting.
What if I need to take more than the standard dose of doxylamine succinate-pyridoxine hydrochloride?
Researchers have looked at the use of doxylamine succinate-pyridoxine hydrochloride in pregnancy when women were prescribed more than the standard dose due to the severity of their symptoms and/or their body weight. There was no increase in the number of adverse pregnancy outcomes for those who used higher doses that were prescribed by their healthcare provider when compared to those who used the standard dose. You should always talk with your health care provider before making any changes in your medications.
Could this medication cause long-term effects on my children if I take it during pregnancy?
Studies that have followed children from ages two to seven years did not find a higher risk of problems associated with doxylamine succinate – pyridoxine hydrochloride when used by their mother during pregnancy.
Can I take doxylamine succinate-pyridoxine hydrochloride while breastfeeding?
There are no formal studies looking at the effects of the combination of doxylamine succinate and pyridoxine hydrochloride on the breastfed infant. Antihistamines that can make mom drowsy could cause drowsiness in a breastfeeding infant, especially when used on a regular basis. Pyridoxine hydrochloride is excreted into breast milk but it has not been associated with any problems in breastfeeding infants. Be sure to talk to your health care provider about all of your breastfeeding questions.
What if the father of the baby takes doxylamine succinate-pyridoxine hydrochloride?
There are no studies looking at possible risks to a pregnancy when the father takes doxylamine-pyridoxine. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures and Pregnancy at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/ .
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Meet An Expert
Dr. Braddock is Professor of Pediatrics and Director of Medical Genetics at Saint Louis University in St. Louis, Missouri, and is board-certified in both Pediatrics and Medical Genetics. He is involved in the evaluation and treatment of individuals with birth defects and the education of healthcare professionals and the general public regarding teratology. Dr. Braddock was the founder and Medical Director of the Missouri Teratogen Information Service (MOTIS) at the University of Missouri. He is also one of the specialists who evaluates the babies participating in MotherToBaby Pregnancy Studies.
– Stephen Braddock, MD
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As a rule of thumb, many pregnant women refrain from taking medication during pregnancy. Not many medications are considered safe to take during gestation. In some instances, however, it cannot be avoided. For me, dealing with depression and insomnia, medication is necessary for me to take both during and outside of pregnancy.
In order to make the decision to medicate as a pregnant woman easier, the FDA has developed a system of categorizing medication for use during pregnancy. The categories are A, B, C, D and X. Medications in category A, for example, are generally considered safe to take during pregnancy. Medications in category B have not been shown to cause problems in humans during pregnancy. Category C medications have too little information to determine whether or not they are safe. As it is unethical to ask pregnant women to volunteer for experimental medications, researchers have to collate the data that already exists and in the case of category C drugs, there is just not enough information. Category D medications are not indicated for use during pregnancy as they have been proven to have adverse effects in humans. Category X drugs should never be used by pregnant women. The risks of taking a category X drug far outweigh any benefits.
When deciding to medicate during pregnancy, one has to weigh the benefits versus the risks of each medication. This is a conversation that is best had with your doctor.
Many people are concerned about the use of antidepressants and anti-anxiety medication during pregnancy, and rightly so. There are some powerful antipsychotics that are known to be completely unsafe for pregnancy and have been shown to cause birth defects. There are some medications, however, that have been categorized as fairly safe to take during pregnancy. Paxil, a popular antidepressant, has been linked to certain heart abnormalities, while Zoloft is considered category B and relatively safe to take during pregnancy.
It must be noted that, when talking to your doctor, you and he or she must weigh the benefits versus the risks of taking any medication. Is taking a person off the medication and risking injury to herself or the fetus worth the risk of remaining on it? In many cases, the benefits of remaining on a medication clearly outweigh the risks.
11 Sleeping Medication
Similar to antidepressants, medication for sleep must be viewed in light of the benefits and risks. Taking a powerful sleep aid such as Ambien throughout pregnancy can cause problems with the newborn at birth, namely withdrawal from the medication post-delivery. Many of these medications cross the placenta and at delivery the infant’s supply of the drug is cut off, cold turkey. The infant may suffer from shakes and inability to sleep or be soothed.
There are a few over-the-counter sleeping medications that are considered safe to take during pregnancy. Unisom, or doxylamine succinate, is one that is considered safe to take. As an insomniac myself, Unisom helped me get through my first pregnancy. Benadryl or diphenhydramine hydrochloride, is another medication that can help you sleep and is considered safe to take during pregnancy. Speak with your obstetrician about possibilities for medications that can help you sleep.
10 Herbal Supplements
People often think that because a substance is natural it is safe. This is not the case and during pregnancy, extra caution must be used when considering whether or not to take herbal supplements. Some herbal supplements have been known to possibly cause miscarriage, premature birth, uterine contractions or injury to the fetus. Aside from these risks, herbal remedies are not regulated as strictly by the Food and Drug Administration as medications and thus the potency of various batches may differ greatly.
Rosemary, for example, is considered “Generally Recognized as Safe,” however, during pregnancy it is considered unsafe as it could cause uterine contractions and premature labor. Don’t, however, be afraid to sprinkle a little rosemary into your spaghetti sauce. There is no risk to the fetus for enjoying Italian food!
Aspirin, a popular pain medication, has been used for many years to treat anything from the common headache to preventing stroke. Generally, it is not recommended to take aspirin during pregnancy, as it is category D, except for with certain medical conditions. High dose aspirin taken during the first trimester poses a risk for pregnancy loss, while high dose aspirin taken in the third trimester can possibly cause premature closing of the vessels of the heart. It can also cause bleeding of the brain in babies who are born premature.
Contradictorily, low dose aspirin of 60-100 milligrams a day might be indicated in the first trimester if a woman has recurrent pregnancy loss due to clotting factor disorders. It is best to talk to your doctor before starting an aspirin regimen.
Ibuprofen is another popular pain killer that is contraindicated during pregnancy, considered category B in the first and second trimesters but category D in the third. Sold in stores under the brand name of Advil or Motrin, it poses much the same threat to a newborn as aspirin, namely causing vessels in the baby’s heart to close prematurely. This can lead to heart or lung damage, or even death. When taken during the third trimester it has also been linked to lower amniotic fluid levels and even prolonged bleeding of the mother during labor. In the first month of pregnancy it could possibly cause miscarriage.
One or two doses throughout the pregnancy likely won’t cause any damage, but it would be wise to try to avoid ibuprofen during pregnancy.
When you’re pregnant and you have a cold, life can be pretty miserable. There are very few things that you are allowed to take during pregnancy for cough and congestion. Sudafed is among these controversial medications of pregnancy, classified in category B. Sudafed is among a group of drugs that can affect the developing vessels of a fetus and may cause vessel restriction. This can lead to a condition called gastroschisis, which is a hole in the abdomen that the fetus’s internal organs can protrude from. It is also linked to preterm birth, intrauterine growth restriction and cardiac problems.
It is not a good idea to take Sudafed during the first trimester, but many doctors feel that it can be safely taken during the second and third trimesters. If you need to take Sudafed during pregnancy, it would be a good idea to talk to your doctor about the benefits versus risks.
Everybody knows that you’re supposed to take prenatal vitamins and folic acid during pregnancy. These are essential for the growth of your baby. I bet you didn’t know that there are some vitamins that should not be taken in excess during pregnancy. Vitamin A in large doses, should not be consumed. At high levels it has been known to be detrimental to fetal development. Many foods contain vitamin A, such as liver and other meats, as well as some enriched foods. Carrots and certain vegetables, however, contain carotene which will convert to vitamin A, only if the body needs it. You cannot consume too much vitamin A by eating carrots and vegetables. An overdose of vitamin A can occur in as little as four times the normal level, meaning it is relatively easy to overdose.
Other vitamins that should be watched out for during pregnancy are vitamins D, E and K. Too much vitamin E has been noted to potentially cause heart defects in a developing fetus. Vitamin K is associated with increased jaundice of the newborn.
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5 Essential Oils
Essential oils are highly concentrated substances extracted from plants and have many benefits; I am a recent convert. From warding off infection, to making safe cleaning supplies and relaxing with a little lavender, essential oils have many amazing uses. There are, however, a few essential oils that are considered unsafe during pregnancy and breastfeeding and it would be wise to take note of these.
Nutmeg may have hallucinogenic effects and can react with pain-relieving drugs taken during labor. Rosemary, as we already know, can cause uterine contractions and can possibly increase blood pressure. Basil, jasmine and sage should be avoided as well as rose and juniper berry. Thyme is an oil that can stimulate contractions. While essential oils have their place, it would be a good idea to talk to your doctor before use during pregnancy.
Sometimes infections during pregnancy cannot be avoided and antibiotics must be taken. While some medications pose risk to the unborn fetus, there are medications that are safer to take than others. Certain medications have the potential to cause congenital abnormalities in newborns. Antibiotics in category X, for example, have been known to cause problems such as anencephaly, choanal atresia (a blockage of the nasal passage), and congenital heart defects, among others.
In some cases, however, the use of antibiotics cannot be avoided. Common infections that occur during pregnancy are urinary tract infections and Group B Strep infections. In the case of Group B Strep, the mother must be treated with antibiotics because of the risk to the newborn during delivery. Passage through the birth canal can allow the bacteria to enter the child’s system through the eyes or nose and cause bacterial meningitis, a serious, life-threatening illness. In this instance the benefits of the antibiotics far outweigh the risks to the fetus. Your doctor will pick the best medication to treat the infection while posing the least threat to the baby.
3 Medication For Morning Sickness
Ah, morning sickness-our favorite part of early pregnancy. Actually, for some people it’s their favorite part of the entire pregnancy, lasting throughout the entire nine months. For some people the nausea is so bad that they cannot get the fluids and nutrition they need for proper fetal development. In these instances, a prescription anti-nausea medication might be indicated. For more mild cases, one half to one whole Unisom may be enough to treat the nausea, but some may need something stronger.
Phenergan, Metoclopramide and Zofran are common medications prescribed to treat nausea during pregnancy. Phenergan can be taken in tablet, suppository or even a cream form. Metoclopramide is a tablet and Zofran can be dissolved under the tongue, negating the need to swallow something on an already iffy stomach. Take it from me, vomiting during pregnancy is no fun and sometimes these medications are absolutely necessary.
Tylenol is another pain and inflammation medication that many people turn to in times of headache. Recently, a study was published that connected frequent use of Tylenol during pregnancy to behavioral problems, ADHD, autism and delayed speech issues in the resulting children. The article didn’t prove an actual link between Tylenol and these conditions, it simply put forth an association.
Regardless, Tylenol is considered safe to take during pregnancy. It is the pain reliever of choice for use by pregnant and breastfeeding women. It doesn’t have the same risks to the fetal heart as Ibuprofen and Aspirin. Fever during pregnancy is considered harmful for the fetus so if you have a fever over 101 degrees, Tylenol is recommended to bring it down to normal range. Be careful, however, when choosing multi-symptom Tylenol relief as it could contain another medication that is contraindicated during pregnancy.
Misoprostol, or Cytotec, is definitely one of the most controversial medications taken during pregnancy. It is used to treat stomach ulcers. When taken during pregnancy, however, it will cause labor to commence. It is used during induction to soften or ripen the cervix. Oxytocin is used to induce labor, but will not work well if the cervix isn’t prepared.
It is also used to cause abortion during early pregnancy. In the case of a missed miscarriage (a miscarriage has occurred but the fetus hasn’t yet left the uterus), it can be used to expel the fetus in lieu of having a dilation and curettage, or D & C. It can cause vomiting, diarrhea and abdominal pain and is considered pregnancy category X.
Sources: Babycenter, American Pregnancy
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