THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Almotriptan should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There is limited safety information available on the use of almotriptan during pregnancy, but animal and human studies suggest low potential risk. Caution is advised when continuing this medication during pregnancy or while nursing a baby.
What is almotriptan?
Almotriptan is a part of a class of medications known as triptans and is currently available as a generic medication in the United States. Almotriptan is available in tablets and is taken as a single dose. It is only available by prescription from your doctor.
What is almotriptan used to treat?
Almotriptan is used to manage acute migraines with or without aura in children over 12 years of age and adults. Migraine is a neurovascular disorder that causes nerves to become inflamed and dilated. Migraine headache is characterized by over 2 hour episodes of pain, a need to be still or silent, and changing location of pain between episodes. Compared to chronic migraine, episodic migraine is characterized by fewer migraine days per month as well as decreased duration and severity of migraines.
How does almotriptan work?
Almotriptan works by binding to serotonin receptors in the brain, causing vasoconstriction or the narrowing of blood vessels to occur as well as decreased inflammation.
If I am taking almotriptan, can it harm my baby?
Possibly. There is limited information on the safety of almotriptan use during pregnancy. It may be recommended to use other medications to treat initial migraine in pregnancy. It is important to consider the risks and benefits of this medication before taking it during pregnancy.
Evidence from animal studies with almotriptan:
When given to pregnant rats at doses up to 958 times the maximum recommended human dose, almotriptan was found to cause death of the baby. Almotriptan administered in doses greater than 80 times the maximum recommended human dose caused skeletal defects in rats. A dose 160 times the maximum recommended human dose administered throughout pregnancy caused low birth weight, decreased litter size, and increased gestational length in offspring. In pregnant rabbits receiving 50 times the recommended human dose, almotriptan was found to cause death of the baby.
Evidence for the risks of almotriptan in human babies:
The Norwegian Mother and Child Cohort Study evaluated triptan use in 69,000 women exposed to triptans during pregnancy. First trimester exposure to triptans was not associated with an increased risk of birth defects. A German study in 432 women found no increase in risk of preterm birth, preeclampsia, or spontaneous abortion with triptan exposure during pregnancy. A study from the Danish Birth Registry evaluated the safety of a similar triptan, sumatriptan, during pregnancy, finding an increased risk of preterm birth and low birth weight likely due to the migraine itself, not sumatriptan. Studies evaluating the effects of in utero triptan exposure on neurobehavioral development have found no negative effects on communication or behavior in 3 years old children.
Bottom line: There is limited safety information available on the use of almotriptan during pregnancy. Human studies that have looked at the safety of triptans during pregnancy note there is no increased risk of birth defects with use during pregnancy. It is important to weigh the risks versus benefits of taking this medication during pregnancy.
If I am taking almotriptan and become pregnant, what should I do?
If you are taking almotriptan 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 almotriptan, can I safely breastfeed my baby?
Caution is advised when administering almotriptan in women who are nursing babies. The effects of almotriptan exposure in nursing infants are unknown.
Bottom line: There are no human reports on the effects of almotriptan in women who are nursing babies. Caution is advised when nursing babies are exposed to almotriptan.
If I am taking almotriptan, will it be more difficult to get pregnant?
Possibly. Animal studies suggest almotriptan may decrease fertility in females.
If I am taking almotriptan, what should I know?
There is limited safety information available on the use of almotriptan during pregnancy. Human studies suggest there is no increase in risk of birth defects with triptan exposure during pregnancy. It is important to weigh the risks versus benefits before taking this medication during pregnancy.
There is no available safety information on the effects of almotriptan in women who are nursing babies. Caution is advised when almotriptan is administered to women who are breastfeeding babies.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of almotriptan 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 almotriptan during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
Janssen: Axert Prescribing Information