FDA issues nipple cream warning

[w8ng4msrgt]

http://i14.photobucket.com/albums/a320/w8ng4msrgt/2008%20Pictures/crise/pkg_nipple-cream.jpg

FDA issues nipple cream warning

Associated Press
(05-24) 04:00 PDT Washington --

The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by Mom Enterprises Inc. of San Rafael.

The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said.

The potentially harmful ingredients in the cream are chlorphenesin and phenoxyethanol.

"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, director of the 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."

The company has stopped selling the cream. The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product.

Mothers whose children may have suffered adverse effects because of this product should contact the FDA's MedWatch at (800) 332-1088.

Link (http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/05/24/BA8C10T1E6.DTL&type=newsbayarea)

[Mom of 4]

http://i14.photobucket.com/albums/a320/w8ng4msrgt/2008%20Pictures/crise/pkg_nipple-cream.jpg

FDA issues nipple cream warning

Associated Press
(05-24) 04:00 PDT Washington --

The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by Mom Enterprises Inc. of San Rafael.

The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said.

The potentially harmful ingredients in the cream are chlorphenesin and phenoxyethanol.

"FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, director of the 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."

The company has stopped selling the cream. The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product.

Mothers whose children may have suffered adverse effects because of this product should contact the FDA's MedWatch at (800) 332-1088.

Link (http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/05/24/BA8C10T1E6.DTL&type=newsbayarea)



Oh great a new way for an idiot mother to make her baby sick and claim ignorance. I can hear it now "it's the nipple cream that did it". :sing:

[petrina]

from drugs.com:
What is the most important information I should know about chlorphenesin?
Chlorphenesin is not commercially available in the United States.
Use caution when driving, operating machinery, or performing other hazardous activities. Chlorphenesin may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking chlorphenesin.
Who should not take chlorphenesin?
Before taking chlorphenesin, tell your doctor if you have liver disease. You may need a lower dose or special monitoring during therapy. It is not known whether chlorphenesin will harm an unborn baby. Do not take chlorphenesin without first talking to your doctor if you are pregnant. It is also not known whether chlorphenesin passes into breast milk. Do not take chlorphenesin without first talking to your doctor if you are breast-feeding a baby. Chlorphenesin is not approved for use in children.

[ImmortalOne]

Oh great a new way for an idiot mother to make her baby sick and claim ignorance. I can hear it now "it's the nipple cream that did it". :sing:

Well there has to be someone out there who's baby got sick and that is why there is a recall on this shit.

[Silvahalo]

I don't trust anything I can't understand. I only use natural products on my babies and breast!

[Dakota Valkyrie]

This nipple cream lists itself as "All Natural". Chlorphenesin and phenoxyethanol are two of the most popular preservatives used in natural skin care products.

In addition to what petrina posted above about chlorphenesin, the FDA warning says "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."

The Greater Good (http://www.burtsbees.com/webapp/wcs/stores/servlet/Burts2/thegreatergood/glossary/good_ingredients.html#p)at Burt's Bees says "Phenoxyethanol: Rose ether. This is a safe anti-bacterial preservative, which protects formulas from microbiological activity."

I can't find much on where Chlorphenesin comes from - other than it is an "organic chemical" (whatever that means).

Because something is natural in no way means it is safe or should get an automatic pass on safety concerns. MANY natural products can cause disastrous side effects and like anything should be used with understanding of dose and possible side effects.

[Lizard]

I'm not having nipple issues--just curious--so, are there safe products out there for moms to use?

[swivel]

That's the same shit I use on my dick when it gets raw!


I better call the neighbors to make sure their kids are feeling OK.

[Nell]

I use Lanisoh. It is just pure lanolin and is recommended by Le Leche. I breast fed 4 kids with it.

[ImmortalOne]

I use something called Breast Therapy. It helped when needed, and normal proper breastfeeding doesn't usually require extensive use of it. Only for those small issues that sometimes arise. And I breastfed all three of my daughters.