Baby 411 Blog

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream

FOR IMMEDIATE RELEASE
May 23, 2008


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.

Dr Brown nipples and Evenflo glass bottles

Here's another alternative, from a pediatrician in Los Angeles:
Dr. Brown standard nipples do fit the Evenflo glass bottles (using the Evenflo "o" ring).

Breastflow and Avent Tempo liners

Sorry for the delay in responding (on vacation this week!). The Breastflow bottles DO contain BPA. However, the Avent Tempo disposable drop-in liners will fit into the bottle and do not seem to leak, and those are BPA-free.

Baby bottle alternatives

Many of the Dr. Brown bottle fans are wondering if there is an BPA free alternative that has a similar flow system.

One thing we discovered is that Breastflow bottles (also very popular for their flow system) are compatible with the Avent tempo bottle liner drop-ins.

You may want to give one a try and see how it goes!

RECALL: Vinyl bibs sold at Babies R Us, Toys R Us

Toys R Us and Babies R Us are recalling vinyl baby bibs from their stores when testing revealed that bibs from one supplier (from guess where--China) contained lead. These bibs were marketed under the names Koala Baby, Especially for Baby, and Disney Baby labels.

Here are the details:

TOYS “R” US, INC. ANNOUNCES PRECAUTIONARY STOP SALE ON ALL VINYL BIBS
Action Includes all Items Manufactured By Hamco, Inc., as Well as Other Vendors

WAYNE, NJ (August 17, 2007) - Toys “R” Us, Inc. announced today that as a precautionary measure it has removed all vinyl bibs manufactured by Hamco, Inc. and its other vendors from Toys “R” Us and Babies “R” Us store shelves.

Because of its strong commitment to safety, Toys “R” Us voluntarily adheres to the stringent California Proposition 65 standards for its testing of vinyl baby bibs. All of its vinyl bibs are tested against these requirements every six months by an independent testing facility. These bibs, including those manufactured by Hamco, passed these rigorous tests, including as recently as May 2007. However, the company noted that stores have received shipments since that time and therefore decided to conduct additional re-testing on these items.

Based on discussions with the Consumer Product Safety Commission staff, following the agency’s own tests conducted last week on certain Hamco bibs sold by Toys “R” Us, there were no instances of any hazardous levels of lead found in these products.

In recent days, Toys “R” Us asked Bureau Veritas, a world leader in independent testing, to re-test samples of all Hamco-manufactured bibs sold by the company. Among its findings, the Bureau Veritas tests found two samples of Hamco bibs that contained lead over the strict Toys “R” Us testing requirements. As a result of inconsistent results between the company’s May 2007 and August 2007 tests, Toys “R” Us has immediately stopped sale of these items in its stores. These bibs were sold to Toys “R” Us by Hamco and marketed under the Koala Baby, Especially for Baby and Disney Baby labels.

While not aware of any concerns regarding vinyl bibs made by other manufacturers, the company has temporarily removed all vinyl bibs from its store shelves to help minimize any potential consumer confusion and as an additional precautionary measure so that the company can voluntarily re-test these products.

In addition to its rigorous testing of all products prior to shipment to its stores, Toys “R” Us has recently increased its third party re-testing of products on store shelves. The company will continue to take decisive and aggressive action in ensuring the products it sells meet only the highest quality assurance standards.

The company said that customers who wish to return vinyl bibs purchased at any time from a Toys “R” Us or Babies “R” Us store may do so and receive a full refund. For questions or additional information, customers may call 1-800-869-7787.

New FDA Warning: Codeine and breastfeeding

Codeine is a popular pain medication that has been used routinely for moms who have had C-sections or pain after childbirth. It's not news that some of the medication passes through breastmilk in small amounts. But, new findings suggest that some women have a genetic predisposition to being "ultra-rapid metabolizers" of the medicine. In those women, the amount of codeine in their breastmilk may be significantly higher, leaving their babies at risk for side effects of the drug-like extreme sleepiness.

As a result, the FDA has issued a new warning about codeine and breastfeeding.

While there is a test available to see if a mom carries the CYP2D6 gene, it's currently not standard of care to perform this test routinely on all breastfeeding mothers. However, the highest risk group to have this gene are typically North Africans, Ethiopians and Saudi Arabians (16% to 28% of women in these groups carry the gene). Caucasians have a 1% to 10% chance of carrying the gene, blacks have a 3% chance, and Hispanics/Asians have a 1% chance.

So, can you use a codeine containing pain medication after delivery if you are nursing? Yes. But, you should be on the look out for a baby who is extremely sleepy and not waking up to feed--especially if you are in the high risk group who may carry the CYP2D6 gene. And, obviously, it's a good idea to wean as quickly as possible to acetaminophen or ibuprofen when you are starting to feel better.

Infant car seats..are they safe?

A case report published in the British Medical Journal today is making headlines: are babies at risk of having breathing problems while in their car seats?

Well, we actually read the case report, and frankly, we are not impressed. The researchers looked at 9 (yes, that's VERY few) babies in New Zealand who had moments of looking blue while sitting in their infant car seats. None of the babies died. Half of the babies had parents who smoked (hmmm . . . perhaps that had something to do with it—but researchers did not address this question). And, based on this extremely small group of children, the researchers have come out with a comment that babies are at risk for suffocating while sleeping in a car seat. Hence, the study concludes, babies shouldn't sleep in their car seats unattended.

Here's what we DO know, based on several other studies on this topic with much larger numbers of children:

1. Babies who are born prematurely (less than 37 weeks gestation), extremely small (under 2500 grams), or those with certain malformations, may be at risk for obstructing their airways while in a standard car seat.

2. The American Academy of Pediatrics recommends that all babies born at less than 37 weeks gestation have a car seat safety test performed (to assess poor oxygenation/respiratory difficulties) before they leave the hospital.

3. Babies who fail a cars eat safety test (usually VERY small babies) may do better in a 5-point harness car seat designed for infants less than 5 pounds than 3-point harness models. Car-beds are also an option for these babies who are at risk.

Bottom line: It's probably a good idea to have someone ride in the backseat with a newborn (if possible) and limit the amount of time your young infant is in that car seat. And we would agree: don't leave an infant unattended to sleep in a car seat.

BUT don't panic---if your child falls asleep in a car seat (as many newborns and infants will do), there is no cause for alarm.