U.S. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream

6/1/2008
 

The us counterpart to the Saudi Food and Drug Authority ,U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants. Potentially harmful ingredients in Mommy's Bliss Nipple Cream 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 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. "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.

The manufacturing company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. Though the U.S. FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.

This product is not registered in Saudi Arabia. It might be available in Saudi Arabia by illegal ways such as travelers bringing this product for personal use, buying it through internet or special order.

Action that the health care professionals and the public should follow:

  • Consumers should discontinue the use of Mommy's Bliss Nipple Cream and 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.

Report Adverse Dug Reaction to the SFDA:

The public and health care professionals are strongly encouraged to report adverse drug reaction to the National Pharmacovigilance Center (NPC) by filling the appropriate form on the following link:

http://www.sfda.gov.sa/En/Drug/Topics/Pharmacovigilance_Center.htm