Nascobal and Pregnancy
Although vitamin B12 supplements may be recommended for use in some pregnant women, it is not known if Nascobal (cyanocobalamin nasal spray) is safe for use during pregnancy. This nasal spray has not been adequately studied in women or animals. If your healthcare provider recommends this product during pregnancy, discuss any potential risks that may apply to you and your unborn child.
Can Pregnant Women Use Nascobal?Nascobal® (cyanocobalamin nasal spray) is a prescription medication approved to prevent or treat low vitamin B12 levels in certain people. At this time, the full risks of using this drug during pregnancy are unknown. However, the medication may be recommended as a vitamin B12 supplement in some pregnant women.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy. Nascobal is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Nascobal has not been adequately studied in pregnant women or animals. As mentioned previously, it is a form of vitamin B12. As with most vitamins, the recommended dietary allowance (RDA) of vitamin B12 is slightly higher for pregnant women than for nonpregnant women in the same age group. More specifically, the RDA of vitamin B12 for pregnant women is 2.6 mcg per day, compared to 2.4 mcg per day for most other adults.
Many pregnant women get enough vitamin B12 through a healthy and well-rounded diet. In addition, prenatal vitamins contain vitamin B12, almost always in doses significantly higher than the RDA. These higher doses are safe for women, as this vitamin has a low risk of toxicity. High doses of vitamin B12 have not been associated with problems in pregnant women or in the developing babies.
While mild cases of vitamin B12 deficiency do not appear to increase the risk for birth defects or other problems, a severe deficiency could cause complications. Some studies have suggested that extremely low vitamin B12 levels may increase the risk for a variety of problems, such as:
- Severe birth defects, including neural tube defects
- Low birth weight
- Preterm birth.
Therefore, women who are at risk for severe vitamin B12 deficiencies will need much more vitamin B12 than is found in a typical prenatal vitamin. This includes women with pernicious anemia and women who follow strict vegetarian diets. In these cases, vitamin B12 injections or Nascobal may be used to provide additional vitamin B12 supplementation.