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.

Measles Outbreak

Since January 2008, there have been 64 cases of measles reported in nine states in the U.S. That may seem like a small number, but it's actually the highest number for the same period of time since 2001. Currently outbreaks are still going on in Arizona, Michigan, New York, and Wisconsin.

63 of the 64 people infected were either unvaccinated or they did not have any record of being vaccinated.

13 of the 64 were children under one year of age, who were too young to be vaccinated.

14 of the 64 (21.9%) people have been hospitalized due to their illness.

Most of these cases were due to exposures outside the United States. Switzerland, Israel, India, Belgium, and China are the countries where these people contracted their illness and then returned to the U.S. infected.

The Centers for Disease Control is currently recommending that babies from 6-11 months of age who are traveling abroad should get one dose of the MMR vaccine before their trip. The standard first dose for all children is at 12-15 months of age.

Plastic baby bottles (again)

We've posted concerns about possible health effects from BPA (bisphenol A) on our blog before, but the National Toxicology Program reaffirmed these concerns this week. The program, which reviewed the existing scientific literature, commented that there may be adverse effects, particularly in infants who are exposed to BPA.

So, if you are in the market for baby bottles and want to limit your child's BPA exposure, choose drop in liner systems, glass bottles, or frosted plastic baby bottles.

(Stop if you've heard this before . . .) Do Vaccines cause Autism?

Like the bad guy in a horror movie that keeps coming back to life, the controversy over vaccines and autism was back in the news last week—again!

The big news involved a decision by the Vaccine Court. What’s that? Here’s an Q&A to help understand the latest events:

What is the Vaccine Court?

    The United States Court of Federal Claims created a National Vaccine Injury Compensation Program in 1988 to give no-fault compensation to people who were injured or died due to vaccination. Over the years, families have never been awarded compensation for children who have autism due to vaccination.
    In June 2007, the federal court began processing about 4800 claims by families who believe their child’s autism was caused by vaccination. This is being called the Omnibus Autism Proceeding. To expedite this process, certain individual claims will be  “Test Cases” first to get a court opinion on the arguments. The 4800 claims are divided into three main arguments or “theories of causation” from the plaintiffs:

1) Did thimerosal (mercury) preservative in vaccines cause the child’s autism?

2) Did the combination MMR vaccine cause the child’s autism?

3) Did the thimerosal preservative and the MMR vaccine cause autism?

    Cases have already been heard, but no formal conclusions will be available until the entire legal process (including appeals) are completed.

What happened in the case that we’ve been hearing about on the news?

    Hannah Poling is a 9 year old girl whose case was reviewed by the vaccine court as a possible test case. After the court reviewed the child’s medical history, it was determined that her situation was NOT appropriate to be a test case by which to judge one of the theories of causation for vaccines causing autism.
    She was born with an underlying mitochondrial disorder, which predisposed her to neurological deterioration. This case is not a typical of other children with autism. The court (not a scientific study) determined that her neurological deterioration may have been aggravated by being vaccinated and settled her case.

What are mitochondria?

    Mitochondria are the powerhouses of our cells, in charge of energy production.

What is a mitochondrial disorder (MD)?

    MD’s are actually a group of several disorders. Many children do not show any symptoms until the body is stressed and requiring extra energy. Some children will have low muscle tone. They may have several episodes of deterioration and recovery. Some disorders affect only body organ, some affect several. Because of that, kids with MD’s can have different symptoms.
    Hannah Poling had an abnormality in the DNA (genetic makeup) of her mitochondria. This type of MD is something you are born with, not something that you develop later in life.

Did the court decide that vaccines triggered a child to have autism?

    No, what the federal vaccine court said was that the vaccinations may have stressed a child who had an underlying disease—this disease predisposed her to have deterioration of her brain and nervous system. Bottom line: Being born with a genetic mitochondrial disorder like Hannah Poling’s is like being born with an aneurysm. It’s a time bomb, waiting to be set off.

Did the court think the vaccines caused the mitochondrial disorder?

    No. The mitochondrial disorder Hannah Poling has is present at birth and it may not manifest any symptoms until the body is stressed. A stomach virus with dehydration, a high fever…any stress that requires body energy may be the tipping point that causes the deterioration.

If a child has a mitochondrial disorder, should he be vaccinated?

    Yes. Neurologists recommend vaccinating even kids with known MD’s because the stress of having the vaccine preventable disease—chickenpox or flu could be far more devastating, and likely more of a problem than the stress of getting vaccinated.

Could mitochondrial disorders explain the rise in children diagnosed with Autism Spectrum Disorders?

    No. Mitochondrial disorders are rare. There is not any significant data to show that the rate of mitochondrial disorders is any higher in children with autism than in the general population.

Can parents request to do a screening test for Mitochondrial Disorders at birth?
   
    We know what the next natural question is… why not just test every child for mitochondrial disorders before vaccinating them?
    Some tests on the state newborn metabolic screens do test for a few mitochondrial disorders (MCAD, LCHAD, VLCAD disorders).
    But, the gold standard tests for diagnosing many of the MD’s are invasive, and require muscle biopsies and spinal fluid. You can’t just do a simple screening blood test for MD before vaccinating all kids.
    And, remember, even if a child has a mitochondrial disorder, the recommendation is still to vaccinate.

Will this case change the vaccine recommendations?

    No, in fact, Dr Julie Gerberding, who heads the Centers for Disease Control, commented that Hannah’s case was a very special situation and that nothing from this case could be generalized to all children.

Why do we give a number of vaccines at the same time?

    There is a method to our madness. Giving several shots at one time is not just a matter of convenience. While doing them all at one office visit will save parents time and co-payments (most insurance companies charge a co-payment for each visit, even if it is just for a nurse to administer a shot), there are three good reasons why:

1. Vulnerability. The children most vulnerable to serious consequences from vaccine-preventable diseases are the youngest. For instance, a two month old with whooping cough, is much more likely to be hospitalized or die from it than a two year old. So, we try to give as many vaccines as we can, as early as we can, as safely as we can, to protect the youngest. We want kids to be protected as soon as possible. Otherwise, it’s just rolling the dice.

2. Insurance issues. While it is fine to give one vaccine or two vaccines at a time and return next week for a couple more, some families don’t have that luxury. They may have health insurance this week and not again for six months. Having a very staggered schedule leaves more risk of kids missing much needed shots.

3. Separation requirements for live vaccines. While some vaccines can be given one week apart, others cannot. Live vaccines must be separated by at least four weeks. Those are measles, mumps, rubella, varicella, flumist, rotavirus. If you decide to separate those out, you have to space them by at least four weeks each time—thus delaying protection until the series can be completed.

Whew! We know this is a bit much to digest—but the important message here is that vaccines do NOT cause autism. And vaccines save lives.

Gene linked to autism

Two separate studies, published this week in the New England Journal of Medicine and in Human Molecular Genetics, identified an abnormal region on Chromosome 16 that is found in 1% of kids with autism.

Obviously, this is not an explanation for all children affected by autism, but it may be the beginning of more research to come on predisposing factors for this developmental disorder.

Mercury out, autism rates still going up

A study, published in the Archives of General Psychiatry this week, looked at the number of cases of autism in California BEFORE thimerosal preservative was removed from the standard recommended vaccination series in 2001 and AFTER. Guess what? The rates of autism are still climbing in California. This is the same thing that Denmark found when they removed thimerosal preservative from their childhood vaccines back in 1992.

Anti-vaccine folks will try to argue the technical flaws in the study, blame the number of vaccines themselves and not the thimerosal, or state that there is still thimerosal preservative in flu vaccines offered to pregnant women.  We don't think any study will ever change their minds.

For everyone else, this is yet one more study that shows we've still got a problem with rising rates of autism and need to continue to aggressively search for the cause. It appears that thimerosal ain't it.

HIB Vaccine Recall

As expected, the Centers for Disease Control have recommended that the booster dose of HIB vaccine (given at either the 12 or 15 month well check) be postponed until the vaccine shortage is over. Children who are considered high risk of getting HIB infection are still prioritized to get their booster shots.

Babies will continue to receive their primary HIB vaccinations at 2 months and 4 months, +/- 6 months of age, depending on which HIB vaccination is used.

We will let you know when the shortage is over so if you have a toddler who misses that booster dose, you can get back into your doc's office to get it.

HIB Vaccine Recall

As you may have heard, Merck pharmaceutical company has recalled 10 lots (batches) of vaccinations that protect against the bacterial infection known as HIB (Haemophilus Influenzae B). This amounts to about 1 million doses being taken off the market. Merck voluntarily did this as a precautionary measure when manufacturing equipment was found to be contaminated with a bacteria called Bacillus cereus. It is unlikely that any individual dose of vaccine would contain any/enough of this contaminant to cause a health problem.

Bacillus cereus can potentially cause a localized infection at the injection site. Thus far, there have not been any reports of infection. If it has been more than a week since your child received a HIB vaccine  with one of the recalled lots (Pedvax HIB, Comvax--lot numbers are available on at cdc.org) and your child did not have any problems, you can stop worrying now.

Because vaccine production is an elaborate process, it will take several months for Merck to get the HIB vaccine supply back up to a steady volume. And, there is only one other vaccine manufacturer that makes HIB vaccine. In the meantime, it's likely that children who have never received HIB vaccine (2 month olds) or those with higher risk of invasive infection with HIB (kids without spleens, leukemia, other cancers, immunecompromised) will be prioritized over those who need a booster dose (usually done at 12-15 months of age).

We anticipate recommendations soon from the Centers for Disease Control and the American Academy of Pediatrics for who will be prioritized to receive HIB vaccine during a shortage. Stay tuned.

New Autism Screening recommendations

The American Academy of Pediatrics now recommends that ALL children be specifically and systematically screened for autism at their 18 month and 2 year old well checks. A questionnaire should be given to parents at both visits and reviewed by the doctor. While there is no one perfect screening test, the one being recommended by the AAP is called the "M CHAT". It is available in the public domain and we will post it on our website for you to download shortly.

The goal is to identify children at risk at an earlier age so that therapy can begin as soon as possible. Kids who have early intensive therapy clearly do better.

The New McCarthyism: Vaccines & Autism

Here is a reprint of guest opinion authored by Dr. Ari Brown in this weekend's Wall Street Journal:

October 27, 2007
   
Vaccines and Autism
By ARI BROWN
October 27, 2007; Page A8

Dangerous vaccines that harm kids. An epidemic of disabled children, hurt by an uncaring medical establishment.

Sounds like a B-grade Hollywood thriller. But this is supposedly a true story as told by actress Jenny McCarthy, author of the best seller, "Louder Than Words: A Mother's Journey in Healing Autism."

When I heard Ms. McCarthy tell Oprah and Larry King that vaccines caused her son's autism, I had a flashback to a cold winter's night, 13 years ago. I was the senior pediatric resident on call in the Intensive Care Unit. Cradled in the arms of her parents, a seven-year-old girl was brought to the emergency room at Children's Hospital Boston. The girl had come down with chickenpox a few days earlier -- she had a fever and hundreds of itchy skin lesions. That night, she had taken a turn for the worse. Her fever shot up to 106 and she became confused and lethargic. She was unresponsive and limp in her mother's arms.

The ER doctors suspected that her open sores allowed Strep bacteria to get under her skin and rage through her bloodstream. Now she was in "multiple system organ failure" -- every square inch of her body was shutting down all at once. IVs were placed into her veins to start fluids, antibiotics and medications to stabilize her heart and blood pressure. She was placed on a ventilator machine to breathe. Then she was brought to the Intensive Care Unit.

By the time I met my patient, she had tubes coming out of every opening and weeping skin lesions all over her body. I was used to blood and gore, but it was hard to look at her and not cry. Imagine how her parents felt when they saw their once-beautiful little girl in this grotesque state, struggling to survive.

My attending physician told me to grab dinner. This child would need me for the rest of the night. I returned to the ICU to find that my patient had gone into cardiac arrest and died. I watched, helplessly, as the nurses placed the little girl into a body bag.

Fast forward five months: The first chickenpox vaccine was approved. That day, I vowed never to let a child on my watch suffer from a disease that was preventable by vaccination.

That's a story that doesn't grab headlines or guest shots on Larry King. Vaccines are one of mankind's greatest scientific achievements. This year alone, they prevented 14 million infections, $40 billion in medical costs, and most important, 33,000 deaths. Yet vaccines are victims of their own success. Today's parents are unfamiliar with the diseases they prevent, but these diseases are alive and well in the U.S. -- I have personally seen children suffer from them.

Call it the New McCarthyism: Who cares about 100 years of scientific research? Vaccines are evil, because the Internet says they are. When a well-meaning parent like Ms. McCarthy blames vaccines for her child's autism, it's dangerous. Celebrity books come and go, but the anxiety they create lives on in pediatricians' offices across the country. A small but growing number of parents are even lying about their religious beliefs to avoid having their children vaccinated, thanks in part to the media hysteria created by this book.

Parents go through stages of grief when their child is diagnosed with a disorder like autism. We all want to blame someone for our suffering. That's understandable. Was there something we could have done as parents to prevent this? But why hasn't the media called out Ms. McCarthy on all the medical inaccuracies in her book? Has anyone actually read it? I have -- cover to cover. Here are two revealing points:

Ms. McCarthy told Oprah that her son was a normal toddler until he received his Measles, Mumps and Rubella vaccine (at 15 months of age). Soon after -- boom -- the soul is gone from his eyes. Yet she contradicts herself in her book: "My friends' babies all cracked a smile way before Evan did . . . he was almost five months old." Which is it? Was he normal until his MMR vaccine or were some of the signs missed before he got that shot?

Ms. McCarthy also contends that mercury in vaccines caused damage to her son's gut and immune system, leading to autism. Yet the mercury preservative Ms. McCarthy assails was removed from the childhood vaccination series in 2001. Her son, Evan, was born in 2002. It's hard to trust Ms. McCarthy's medical degree from the University of Google -- she comments about the Hepatitis C vaccine that wreaked havoc on a friend's child. An inconvenient truth: There is no Hepatitis C vaccine.

Doctors do need to do a better job of guiding families through the maze of autism treatments. I also desperately want to know why autism happens and how to treat it. But let's put our energy into funding autism research and treatment, not demonizing our vaccination program.

Ms. McCarthy is in the trenches, fighting for her son. I, too, am fighting. I am on the front lines everyday, trying to keep our kids healthy and protected. And, after all I have seen, one thing is certain -- I've vaccinated my own kids and would do it again in a heartbeat.

Dr. Brown, a pediatrician in Austin, Texas, is a fellow of the American Academy of Pediatrics.