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Dronabinol Pregnancy and Breastfeeding Warnings

Dronabinol is also known as: Marinol, Syndros

Dronabinol Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk summary: Use may result in fetal harm.

Comment: Neonates exposed to cannabis may be at risk of fetal growth restriction, preterm birth, low birth weight, small-for-gestational age, neonatal intensive care unit admission, and stillbirth.

Animal studies have not revealed any evidence of teratogenicity. Adverse effects including decreased maternal weight gain and number of viable pups, and increased fetal mortality and early resorptions were dose-dependent and less apparent at lower doses which produced less maternal toxicity. There are no controlled data in human pregnancy.

Animal studies also showed some fertility effects including reduced ventral prostate, seminal vesicle, and epididymal weights and decreased seminal fluid volume, spermatogenesis, number of developing germ cells, and number of Leydig cells in the testis. However, no effect has been observed on sperm count, mating success, and testosterone levels.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Dronabinol Breastfeeding Warnings

Use in nursing mothers is not recommended.

Excreted into human milk: Yes

Comments:
-This drug is absorbed by the nursing infant. There are limited data on the effects on the nursing infant.
-Patients with nausea and vomiting associated with chemotherapy should avoid breastfeeding for at least 9 days after the last dose.

One long-term study found that daily or near daily marijuana use might delay a breastfed infant's motor development, but not growth or intellectual development. Other studies found that occasional maternal marijuana use during breastfeeding did not have any discernible effects on nursing infants, but these studies were inadequate to rule out all long-term harm.

See references

References for pregnancy information

  1. "Product Information. Marinol (dronabinol)." Roxane Laboratories Inc, Columbus, OH.
  2. "Product Information. Syndros (dronabinol)." Insys Therapeutics Inc, Phoenix, AZ.

References for breastfeeding information

  1. "Product Information. Marinol (dronabinol)." Roxane Laboratories Inc, Columbus, OH.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Syndros (dronabinol)." Insys Therapeutics Inc, Phoenix, AZ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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