Terra Sigillata

I missed this FDA warning in my e-mail box this week. But given the use of such products by breast-feeding women we know, I think this warning is worth publicizing here – chlorphenesin is a centrally-active skeletal muscle relaxant that is for some reason used in cosmetics but is not intended for oral consumption:

FDA Warns Consumers Against Using Mommy’s Bliss Nipple Cream
Product can be harmful to nursing infants

The 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.

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. Please seek immediate medical attention if your child is showing these signs and symptoms.

“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.”

Though the 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.

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.

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.

Comments

  1. #1 MMOToole
    May 26, 2008

    Whatever happened to plain old fashioned lanolin?

    I’m serious. You can’t find the stuff anymore. You can find some creams/lotions with it, but not the plain stuff without all the additives.

    We might as well start recommending Bag Balm´┐Ż…

  2. #2 Rugosa
    May 26, 2008

    I wouldn’t recommend Bag Balm for a nursing mother’s nipples (have no idea if would harm the baby), but it sure is great hand creme for winter- and gardening-chapped hands.

  3. #3 acmegirl
    May 26, 2008

    Good old fashioned lanolin is still available. The brand Lansinoh is pure lanolin with no additives. I used it myself a few times.

    I think it’s also important to note is that cracked and sore nipples can be indicative of a real problem with latching on. A baby not latching on to the breast correctly will not only result in sore nipples, but also the let-down reflex may not be adequately stimulated. In the short term, this means the baby won’t get enough at a feeding. In the long term, this can mean that the milk supply may never become established, ultimately leading to breastfeeding “failure”.

    I’ve heard so many women say that they couldn’t breastfeed because it was too sore – having never spoken to a lactation consultant. When a baby is latching on correctly, nursing should not be painful. However, it’s not always obvious to a new (or even repeat) mother what is the problem. If nursing hurts, don’t spend money on creams – call your pediatrician and ask for a referral to a lactation consultant!

  4. #4 davidp
    May 27, 2008

    When my children were babies (a decade ago), there were rumours that lanolin (wool fat) might contain pesticide residues – from the sheep dips. These rumours were spread by Australian mothercraft nurses, so the market for lanolin as nipple treatment probably plummetted.
    I googled this today and found http://www.fda.gov/bbs/topics/ANSWERS/ANS00191.html saying the health risk to babies is negligible.
    http://www.orion.net.au/faqs/lan00913_faq.pdf says Medical grade lanolin (British pharmacopeia) specifies less than 1ppm total insecticide residue, which seems a pretty high limit to me!

  5. #5 Chas
    May 27, 2008

    Lanolin? We used Vitamin E, taken from a punctured capsule. My S.O. said it worked pretty well. Both our daughters nursed for almost 3 years each, too. Let’s hear it for LaLeche League!

  6. #6 Liz
    May 28, 2008

    $12.00 for a 2-ounce tube. What’s wrong with olive oil? You’re using breast pads anyway to catch those pesky leaks…

    And for dry, cracked hands, you can ditch the BagBalm in favor of Corona Ointment, because it comes in tubes.

  7. #7 acnerdz
    May 31, 2008

    topical vitamins like vitamin-E is safer.

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