FDA Warning about Mommy’s Bliss Nipple Cream

Yesterday the U.S. Food and Drug Administration issued a warning against the use of Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, Inc. to nursing mothers for treatment of cracked and sore nipples. The packaging specifically states that it is not necessary to remove the cream before nursing, but two ingredients in the cream may be harmful to nursing infants. The FDA describes the dangers of chlorphenesin and phenoxyethanol:

Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers should discontinue use of the product and watch for the following signs of infant distress (and seek immediate medical assistance for any of these symptoms):

~ decrease in an infant’s appetite
~ difficulty in awakening the child
~ limpness of extremities
~ decrease in an infant’s strength of grip
~ a change in skin color.

Mothers using the cream may suffer from dermatitis as well.

The FDA says consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency’s voluntary reporting program, by e-mail at www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Thanks to Marijke at the new b5media pregnancy blog, Womb Within, for the information on this story!