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THIAMINE HYDROCHLORIDE BP: Thiamine Hydrochloride has to be used with caution during lactation.
PYRIDOXINE HYDROCHLORIDE BP: Pyridoxine is likely safe for pregnant women when taken under the supervision of their healthcare provider. It is sometimes used in pregnancy to control morning sickness. High doses are unsafe. High doses can cause newborns to have seizures. Pyridoxine is likely safe for breast-feeding women when used in amounts not larger than 2 mg per day. Avoid using higher amounts. Not enough is known about the safety of pyridoxine at higher doses in breast-feeding women.
NICOTINAMIDE BP: Teratogenicity/Effects in Pregnancy: U.S. Food and Drug Administration's Pregnancy Category: Category C (All Trimesters): Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Australian Drug Evaluation Committee's (ADEC) Category: B2 (Batagol, 1996): Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Crosses Placenta: Yes.
Clinical Management: It is not known whether doses of niacin used in treating lipid disorders can cause fetal harm when given to pregnant women or whether it affects fertility. If a woman being treated for hypercholesterolemia (Type IIa or IIb) becomes pregnant, niacin should be discontinued. If a woman being treated for hypertriglyceridemia (Types IV or V) conceives, the benefits and risks of continuation should be determined on an individual basis. Nutritional supplement doses of vitamins and minerals are generally considered safe during pregnancy. Daily dietary niacin requirements are increased during pregnancy to a recommended dietary reference intake of 18 nanograms niacin equivalents, an amount almost 30% over nonreproducing adult women.
Breastfeeding: Thomson Lactation Rating: Infant risk cannot be ruled out: Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding.
Clinical Management: Niacin, in the extended release formulation, has been reported to appear in human milk. The recommended daily intake of niacin during lactation is 18 to 20 mg of the standard release formulation. It is not known if higher doses would result in clinically significant consequences for the nursing infant. It is not known if niacin affects the quantity or composition of breastmilk.
Literature Reports: Information is limited with regard to the safety of high-dose niacin, used in the treatment of hypercholesterolemia or hypertriglyceridemia, in the nursing infant. Until additional data are available, an attempt should be made to control cholesterol and triglycerides with dietary measures if the patient plans to breastfeed her infant.
LYSINE HYDROCHLORIDE USP: Lysine supplementation in combination with vitamins and iron supplementation increased hemoglobin levels in pregnant women.
CYANOCOBALAMIN BP: TERATOGENICITY: U.S. Food and Drug Administration's Pregnancy Category C.
There is no evidence that low levels of vitamin B12 are associated with congenital malformations.
EFFECTS IN PREGNANCY: The recommended dietary allowance (RDA) of vitamin B12 during pregnancy is 2.2 micrograms/day, and this is usually provided by an adequate diet (USPDI, 1993). However, dietary supplementation may be required during pregnancy in strict vegetarians (AMA, 1991).
