Critical caveats in using product information/pregnancy categories for pregnant or breastfeeding patients

Abstract

Many healthcare professionals (HCPs) base their advice to pregnant or breastfeeding women on Monthly Index of Medical Specialties, Medical Director or the Consumer Medicines Information, which draw from manufacturers’ product information. This information does not reflect evidence-based studies, but rather is based on animal studies conducted prior to the product’s approval for use in humans and is rarely updated. The aim of this paper is to inform HCPs of the evidence-based resources available to assist decision making when treating pregnant or breastfeeding women. Women often have conditions that require treatment during their pregnancies. Experience at MotherSafe indicates that women who are pregnant or breastfeeding are frequently treated with excessive caution or even refused needed treatment by doctors and pharmacists. Product information and evidence-based sources often vary greatly in their recommendations for pregnant and lactating women. By not assessing the risks and benefits for their patients, an adverse outcome for mothers and babies may well be the result – the very outcome the cautious approach of HCPs seeks to avoid.