Pharmacy Times 2008 OTC Products - (Page 58) Safety of OTC Medications in Pregnant Women Table 2—FDA Pregnancy Risk Factors Category A Category B In controlled human studies, drug does not demonstrate risk to fetus in any trimester. In animal studies, drug does not demonstrate risk to fetus, and there are no controlled human studies. or In animal studies, drug is associated with adverse effect, and in controlled human studies, drug does not demonstrate risk to fetus in any trimester. In animal studies, drug is associated with adverse effect, and there are no controlled human studies. or There are no animal or human studies. Use of drug in pregnant women demonstrates risk to human fetus, but potential benefit to mother may outweigh risk to fetus. In animal studies, drug demonstrates fetal abnormalities, and potential risk to fetus outweighs benefit to mother. or In human studies or experience, drug demonstrates fetal abnormalities, and potential risk to fetus outweighs benefit to mother. Category C Drug should be used only if potential benefit outweighs potential risk to fetus. Category D Drug should only be used in a serious or life-threatening situation when alternatives are unavailable or ineffective. Category X Drug is contraindicated in women who are pregnant or may become pregnant. Adapted from reference 1. cists should always take certain factors into consideration, including stage of pregnancy and embryoI M M AC logic development, safety of the ingredients, route of administration, dose, and any other medications SINCE that the patient may be taking. Products with the 1997 8 w Ac fewest number of safe ingredients should be chosen h ie vem e n t A and administered in the lowest dose possible. It also is important to educate the patient to follow ST REC O EN directions carefully and to use the product for the shortest duration necessary. If possible, nonpharmacologic therapy should be the first recommendation made by a pharmacist. If symptoms can be adequately relieved, then the risk associated with medication use may be avoided. P T For a list of references, go to: • PH AR M D ED • ar M M PH AR PH AR d 8 Ac w h ie vem e n t A 8 ar Ac Vitamin C M AC w h ie vem e n t A ar d M PH AR PH AR d ar Number of pharmacist recommendations per month: 435,960 ar d 20 d 0 8 www.PharmacyTimes.com. AC IS T REC O M M AC IS T REC O M OTCs Pharmacists Recommend E E EN M EN D ED D ED 20 20 20 0 0 0 AC IS T REC O M Product M IS T REC O M M % of Pharmacist Recommendations Yeast Infection Prevention and Relief—Homeopathic/Natural Product % of Pharmacist Recommendations Ester-C Emergen C 8 Easy C w 8 Ac w Ac h ie vem e n t A h ie vem e n t A Right C Nature’s Bounty Nature Made Other D ED 20 OTC Supplement 2008 EN 33.3 12.6 2.7 0.9 1.8 1.8 46.9 EN D ED AZO Yeast Yeast Gard Nature’s Cure Other 40.0 28.0 6.0 26.0 0 Number of pharmacist recommendations per month: 378,000 58 Pharmacy Times http://www.PharmacyTimes.com
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