May 27, 2008 -- The FDA is warning consumers not to use or purchase Mommy's Bliss Nipple Cream marketed by MOM Enterprises Inc. of San Rafael, Calif., because ingredients in the cream may harm nursing babies.
The FDA hasn't gotten any reports of illness linked to the cream. But because of the potential risk, the FDA is alerting mothers and caregivers to seek immediate medical attention about these signs and symptoms in infants exposed to Mommy's Bliss Nipple Cream: decrease in appetite, difficulty in waking the child, limp extremities, a weakening of the infants' grip strength, and a change in skin color.
The product's label specifically states that there is no need for mothers to remove the cream before nursing. But two ingredients in the product may cause respiratory distress or vomiting and diarrhea in infants, notes the FDA.
Those ingredients are 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's mainly used in cosmetics and medications. It can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.
"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a news release.
The FDA advises nursing mothers with cracked, painful nipples to speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.
MOM Enterprises has stopped marketing the nipple cream with potentially harmful ingredients, according to the FDA.