FDA Warns Consumers Against Using Mommy’s Bliss Nipple Cream
as Ingredients May Be Harmful to Infants
May 27, 2008 - DENVER— The Colorado Department of
Public Health and Environment’s Consumer Protection Division
joined the U.S. Food and Drug Administration (FDA) Monday in
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 for 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 the product contains are
chlorphenesin and phenoxyethanol. Chlorphenesin relaxes
skeletal muscle and can depress the central nervous system
and cause 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.
Although the FDA has not received any reports of illness to
infants, the agency is alerting the public because of the
potential harm the product can have on a child.
MOM Enterprises Inc., which is based in San Rafael, Calif.,
stated that it immediately discontinued selling and
marketing the nipple cream several days ago when the FDA
informed them about the potential risks.
If the nipple cream has been used by nursing mothers, state
health officials advised them and/or their caregivers to
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.
Dan Rifkin with the Department of Public Health and
Environment’s Consumer Protection Division urged parents to
seek immediate medical attention for their child if their
child is showing these signs and symptoms.
Dr. Janet Woodcock, director of FDA’s Center for Drug
Evaluation and Research, said, “The FDA is particularly
concerned that nursing infants are being exposed to this
product by their mothers who are unaware of the potential
dangerous side effects. Additionally, these two ingredients
may interact with one another to further compound and
increase the risk of respiratory depression in nursing
infants.”
Chlorphenesin also can harm the mother by causing
dermatitis, a skin condition that can worsen the drying and
cracking of nipple skin, Woodcock said.
Nursing mothers with cracked, painful nipples, 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.
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. Visit
www.fda.gov/medwatch/report.htm for a voluntary
reporting form or report adverse events by phone at
800-332-1088, or by fax to 800-332-0178. Consumers also may
mail reports of adverse events to MedWatch, U.S. Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD,
20852-9787.
For more information, Colorado residents may call Dan Rifkin
at 303-692-3644.
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