FDA alert on dangerous nipple cream recall

 

 

Posted by Susan Markel, M.D. in Breastfeeding, Recalls | May 27th, 2008 | Trackback

The U.S. Food and Drug Administration has issued a warning to consumers not to use a cream sold to nursing mothers to help soothe dry and cracked nipples because it contains ingredients potentially harmful to babies.

Mommy’s Bliss Nipple Cream contains chlorphenesin and phenoxyethanol, which can affect an infant’s central nervous system, causing respiratory depression, vomiting, and diarrhea.

Mothers and caregivers should watch for a decrease in an infant’s appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant’s strength of grip and a change in skin color. You must seek  immediate medical attention if your child is showing these signs and symptoms. according to the FDA.

Although product labeling specifically states that there is no need for mothers to remove the cream prior to nursing, the ingredients contained in the product are harmful to nursing infants.

MOM Enterprises, the company marketing the product, is offering a full refund for returned cream and has issued a product bulletin.

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 may cause vomiting and diarrhea which can lead to dehydration in infants.

“The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants.”

Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.

MOM Enterprises, Inc. is based in San Rafael, Calif. The company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. The FDA is advising consumers to discontinue use of Mommy’s Bliss Nipple Cream and to consult a health care professional if they experience problems or believe that their infant may have experienced problems due to this product. Nursing mothers with cracked, painful nipples, which is often a side effect of nursing, should speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.