D.H.E. 45

THE SAFETY OF DIHYDROERGOTAMINE DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Dihydroergotamine should not be taken during pregnancy or while breastfeeding a baby. Human and animal studies indicate that taking dihydroergotamine during pregnancy may be harmful to the developing baby.

What is dihydroergotamine?

Dihydroergotamine is a medication that is taken to control the symptoms of migraine headache in adults. Dihydroergotamine is currently available as brand name (Migranal, D.H.E. 45) and generic medications in the United States. Dihydroergotamine is available in solution for injection and nasal spray and is taken at least once daily. It is only available by prescription from your doctor. 

What is dihydroergotamine used to treat?

Dihydroergotamine is used to treat migraine headache with or without aura, cluster headache, and severe migraine headache lasting for more than 72 hours (status migrainosus) in adults. Cluster headache is a headache disorder characterized by severe headaches that occur in a series (for example, every other day up to several times a day) and last for 15 minutes to 2 hours, followed by a period of remission lasting more than a 1 month. Symptoms of a cluster headache include severe nerve pain on one side of the head and near the eyes or temple. A cluster headache is considered the most painful type of headache. Patients may also experience other symptoms including red eyes, tearing, facial sweating, droopy eyelids, runny nose, congestion, or restlessness. Cluster headache is differentiated from migraine headache based on symptoms and severity, Migraine headache is characterized by episodes of pain lasting over 2 hours, desire to be still or silent, changing location of pain between episodes, and a lack of the facial symptoms associated with cluster headache.

How does dihydroergotamine work?

Dihydroergotamine works by activating serotonin receptors of the blood vessels in the brain, causing narrowing of the blood vessels (vasoconstriction) and activation of serotonin receptors on the trigeminal nerve that decrease the release of inflammatory chemicals. 

If I am taking dihydroergotamine, can it harm my baby?

Dihydroergotamine should be avoided during pregnancy. Dihydroergotamine stimulates uterine contractions similar to oxytocin and can cause the developing baby not to get enough oxygen. Human and animal studies have not reported an increase in the risk of birth defects in babies exposed to dihydroergotamine in the womb. 

Evidence from animal studies with dihydroergotamine:

When given to pregnant rats during fetal organ development at intranasal doses 0.4 to 1.2 times the maximum recommended human dose, dihydroergotamine was found to cause reduced body weight and delayed bone development. When administering a similar intranasal dose throughout pregnancy, dihydroergotamine was associated with decreased body weight and alterations to reproductive function in offspring. When given to pregnant rabbits during fetal organ development at intranasal doses 7 times the maximum recommended human dose,  dihydroergotamine was associated with delayed bone development in offspring. Pregnant guinea pigs given dihydroergotamine during pregnancy had decreased placental blood flow and decreased fetal body weights.

Evidence for the risks of dihydroergotamine in human babies:

A comprehensive review of 11 published studies found no increase in the risk of birth defects with dihydroergotamine exposure during pregnancy; however, there was an increase in premature delivery with exposure to this medication. The Collaborative Perinatal Project monitored 32 women and their babies who were exposed to dihydroergotamine or similar medications during the first trimester. Three babies were reported to have developed birth defects, but the study authors noted that the study was too small to establish any relationship between dihydroergotamine or similar medications and birth defects. The Swedish Medical Birth registry (1995-1999) evaluated 51 babies born to women with dihydroergotamine exposure during pregnancy, finding no increase in the risk of preterm delivery, birth defects, or miscarriage. A review of  Swedish Medical Birth registry data from 1996 to 2005 reported an increased risk in preterm delivery with use of dihydroergotamine during late pregnancy. Use of dihydroergotamine during early pregnancy was associated with an increased risk of preeclampsia. The Quebec Pregnancy Registry found no increase in the risk of birth defects or poor growth in babies born to mothers who used dihydroergotamine during early pregnancy; however, there was an increase in risk of premature delivery with early dihydroergotamine exposure during pregnancy. 

Bottom line: Dihydroergotamine should not be used during pregnancy. Although human and animal studies do not show an increased risk of birth defects with in utero dihydroergotamine exposure, dihydroergotamine may be harmful to the developing baby.

If I am taking dihydroergotamine and become pregnant, what should I do?

If you are taking dihydroergotamine 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.

If I am taking dihydroergotamine, can I safely breastfeed my baby?

Dihydroergotamine should be avoided while nursing infants. There are a lack of studies evaluating the safety of this medication while breastfeeding a baby.  Dihydroergotamine suppresses milk production in a new mother. Dihydroergotamine may be excreted into breast milk; potential complications in nursing babies may include vomiting, diarrhea, slow heartbeat or pulse, and altered blood pressure. In breastfeeding moms are taking dihydroergotamine, either breastfeeding or the medication should be discontinued.

Bottom line: In breastfeeding moms who are taking dihydroergotamine, either breastfeeding or the medication should be discontinued. Potential side effects in nursing babies include vomiting, diarrhea, slow heartbeat or pulse, and altered blood pressure.

If I am taking dihydroergotamine, will it be more difficult to get pregnant?

A study in rats given intranasal dihydroergotamine at 9 to 11 times the maximum recommended human dose reported no negative effects on fertility. 

If I am taking dihydroergotamine, what should I know?

Dihydroergotamine should not be used during pregnancy or while breastfeeding a baby. Taking medications such as dihydroergotamine may increase the risk of health problems in newborn babies.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of dihydroergotamine during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about pain and the individual medications used to treat pain here,  and our reports about neurological disorders, including migraine headaches, and the medications used to treat them here.   Additional information can also be found in the resources below. 

For more information about dihydroergotamine during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

American Migraine Foundation: Cluster Headach
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Bausch Health:  Migranal Prescribing Information

U.S. Food and Drug Administration:  D.H.E. 45 Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.