Helping to prevent birth defects

It's important that patients receive folic acid supplementation both before and during pregnancy

Folic acid is the synthetic form of folate found in many commercially available foods and supplements.1 The richest dietary sources of folic acid come from fortified foods such as cereals, bread, pasta, flour, crackers, and orange juice. Folate also naturally occurs in green leafy vegetables, including spinach and collard greens, as well as in citrus fruits like oranges and lemons.1,2

Most women, however, do not obtain sufficient folic acid through diet alone.1 Low plasma levels of folate during pregnancy have been associated with increased risk of3-5:

  • Preterm birth
  • Low infant birth weight
  • Fetal growth retardation

With 1 mg (1000 mcg) of folic acid in each tablet, PreferaOB ONE® meets the American Congress of Obstetricians and Gynecologists (ACOG) recommendation for daily folic acid intake during pregnancy.2 This can help prevent spina bifida and anencephaly, birth defects of the brain and spinal cord known as neural tube defects.1,3,6,7

INDICATIONS AND USAGE: PreferaOB ONE® is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB ONE® is also beneficial in improving the nutritional status of women prior to conception.

IMPORTANT SAFETY INFORMATION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Ingestion of more than 3 grams of Omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.

PRECAUTIONS: Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information.

References

1. US Department of Health and Human Services. Office on Women's Health. Frequently asked questions: folic acid. http://www.womenshealth.gov/publications/our-publications/fact-sheet/folic-acid.pdf. Updated May 18, 2010. Accessed December 7, 2011. You'll need the Adobe® Acrobat® Reader in order to view this document. You can download it for free here. 2. The American Congress of Obstetricians and Gynecologists. Frequently asked questions: healthy eating. FAQ130. http://www.acog.org/publications/faq/faq130.pdf. Published August 2011. Accessed December 7, 2011. You'll need the Adobe® Acrobat® Reader in order to view this document. You can download it for free here. 3. McArdle HJ, Ashworth CJ. Micronutrients in fetal growth and development. Br Med Bull. 1999;55(3):499-510. 4. Scholl TO, Johnson WG. Folic acid: influence on the outcome of pregnancy. Am J Clin Nutr. 2000;71(5)(suppl):1295S-1303S. 5. Bukowski R, Malone FD, Porter FT, et al. Preconceptional folate supplementation and the risk of spontaneous preterm birth: a cohort study. PLoS Med. 2009;6(5):e1000061. 6. Honein MA, Paulozzi LJ, Mathews TJ, Erickson JD, Wong LY. Impact of folic acid fortification of the US food supply on the occurrence of neural tube defects. JAMA. 2001;285(23): 2981-2986. 7. Czeizel AE, Dudás I. Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation. N Engl J Med. 1992;327(26):1832-1835.