24
Table 9. Lipid Lowering Agents and Pregnancy Categories
a
Lipid-lowering class or agent
Pregnancy category
b
Statins X
Fibrates C
Ezetimibe C
Niacin C
Cholestyramine C
Omega-3 fatty acids C
Colesevelam B
Mipomersen B
a
ese categories were removed from drug labeling per the new FDA labeling guidance effective
June 30, 2015, and instead drug labeling will include a summary of the risks of using a drug during
pregnancy and lactation, discussion of data supporting that summary, and relevant information to
assist health care providers in treatment decisions for pregnancy, lactation, and females and males
of reproductive potential.
b
Categories previously established by the FDA to indicate the potential of a drug to cause birth
defects if used during pregnancy.
B – Animal reproduction studies have failed to demonstrate a risk to the fetus, and there are no
adequate and well-controlled studies in pregnant women.
C – Animal reproduction studies have shown an adverse effect on the fetus, and there are no
adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug
in pregnant women despite potential risks.
X – Studies in animals or humans have demonstrated fetal abnormalities, and/or there is positive
evidence of human fetal risk based on adverse reaction data from investigational or marketing
experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential
benefits.
Table 10. Criteria for Diagnosis of PCOS
Criteria
NIH 1990
"classic"
Rotterdam
2003
Androgen
Excess-PCOS
Oligomenorrhea
a
+ +/- +/-
Clinical or biochemical
hyperandrogenism
b
+ +/-
+/-
Polycystic ovaries on ultrasound
c
+/- +/- +/-
• NIH: both oligomenorrhea and clinical/biochemical hyperandrogenism
• Rotterdam: any 2 of the criteria
• AE-PCOS: presence of clinical/biochemical hyperandrogenism and 1 other criterion
a
8 or fewer menses per year
b
Acne, or hirsutism, or androgenic alopecia
c
Ovarian volume >10 mL and/or >12 follicles <9 mm in at least 1 ovary
Special Populations
