Niacin/lovastatin use in specific populations

{{Niacin/lovastatin}} Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Use In Specific Populations

Pregnancy

Pregnancy Category X

ADVICOR should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazard. Safety in pregnant women has not been established and there is no apparent benefit to therapy with ADVICOR during pregnancy (see CONTRAINDICATIONS). Treatment should be immediately discontinued as soon as pregnancy is recognized.

Niacin

Animal reproduction studies have not been conducted with niacin or with ADVICOR. It is also not known whether niacin at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. If a woman receiving niacin or ADVICOR for primary hypercholesterolemia becomes pregnant, the drug should be discontinued.

lovastatin

Rare reports of congenital anomalies have been received following intrauterine exposure to HMG-CoA reductase inhibitors. In a review5 of approximately 100 prospectively followed pregnancies in women exposed to lovastatin or another structurally related HMG-CoA reductase inhibitor, the incidences of congenital anomalies, spontaneous abortions and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate only to exclude a 3- to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.

lovastatin has been shown to produce skeletal malformations at plasma levels 40 times the human exposure (for mouse fetus) and 80 times the human exposure (for rat fetus) based on mg/m2 surface area (doses were 800 mg/kg/day). No drug-induced changes were seen in either species at multiples of 8 times (rat) or 4 times (mouse) based on surface area. No evidence of malformations was noted in rabbits at exposures up to 3 times the human exposure (dose of 15 mg/kg/day, highest tolerated dose).

Labor and Delivery

No studies have been conducted on the effect of ADVICOR, niacin or lovastatin on the mother or the fetus during labor or delivery, on the duration of labor or delivery, or on the growth, development, and functional maturation of the child.

Nursing Mothers

No studies have been conducted with ADVICOR in nursing mothers.

Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of niacin and lovastatin (see CONTRAINDICATIONS), ADVICOR should not be taken while a woman is breastfeeding.

niacin has been reported to be excreted in human milk. It is not known whether lovastatin is excreted in human milk. A small amount of another drug in this class is excreted in human breast milk.

Pediatric Use

No studies in patients under 18 years-of-age have been conducted with ADVICOR. Because pediatric patients are not likely to benefit from cholesterol lowering for at least a decade and because experience with this drug or its active ingredients is limited, treatment of pediatric patients with ADVICOR is not recommended at this time.

Geriatric Use

Of the 214 patients who received ADVICOR in double-blind clinical studies, 37.4% were 65 years-of-age and older, and of the 814 patients who received ADVICOR in open-label clinical studies, 36.2% were 65 years-of-age and older. Responses in LDL-C, HDL-C, and TG were similar in geriatric patients. No overall differences in the percentage of patients with adverse events were observed between older and younger patients. No overall differences were observed in selected chemistry values between the two groups except for amylase which was higher in older patients.