McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

Fort Washington, PA (April 30, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

Health and Your Childʼs Symptoms

It can be distressing as a parent to watch your child endure the uncomfortable symptoms of a cold or flu. We donʼt want to see our children suffer unnecessarily. But have you ever considered that the expression of symptoms can be good for your childʼs health?

For example, an elevated body temperature helps the immune system to kill a pathogen. The watery eyes and runny nose that accompany a cold are a way for the childʼs body to flush out that pathogen. When we get sick, the immune systemʼs job is to once again get the body well. And a childʼs body does this by manifesting symptoms.

But hereʼs the tricky thing about all those pesky symptoms: they appear long after the balance of health has been altered. In fact, symptoms are the last thing to show up in the course of a disease or illness. By the time that nose is running and you are chasing your toddler around the house with a tissue, her immune system is already fighting off the offending bug in full force. And, believe it or not, that fever and the head congestion are just what she needs to effectively and efficiently rid her body of the invader, once and for all.

There are natural ways you can support your childʼs healing process during such bouts of symptom expression. Health-restoring treatments such as chiropractic, acupuncture, homeopathic remedies, and herbal supplements can help strengthen the childʼs immune response from the inside-out. Health comes from within. A childʼs body is perfectly designed to regulate itself and to deal with slight imbalances in itʼs homeostasis.

Over-the-counter pharmaceuticals do not actually heal the body; instead they suppress symptoms. Giving your child symptom-suppressing medications can actually stifle the natural course of the healing process. They may indeed alleviate the childʼs discomfort.

Understandably, this makes you, the parent, feel better because your child is not suffering. But in the long run it makes your childʼs body have to work harder to overcome the illness because the natural course of the recovery has been interrupted or stifled. Symptom-suppressing medications operate from the outside-in, whereas the body was designed to heal itself from the inside-out. By the time the symptoms show up, the child is already well on her way to recovery. Getting through the symptom part of the illness can be messy, to say the least, but your childʼs body will be stronger because of it. Those pesky symptoms are a means to an end, and a childʼs body knows just how to heal itself.

Stephanie Harris, D.C., has a family wellness practice in downtown Durango. She can be reached at drstephdc@gmail.com.

 The Miracle of Vitamin D: Sound Science, or Hype?

By TARA PARKER-POPE

Imagine a treatment that could build bones, strengthen the immune system and lower the risks of illnesses like diabetes, heart and kidney disease, high blood pressure and cancer.

Some research suggests that such a wonder treatment already exists. It’s vitamin D, a nutrient that the body makes from sunlight and that is also found in fish and fortified milk.

Yet despite the health potential of vitamin D, as many as half of all adults and children are said to have less than optimum levels and as many as 10 percent of children are highly deficient, according to a 2008 report in The American Journal of Clinical Nutrition. Read more.

So I’d found myself in this advanced state of addiction to local, fresh food when I looked in our frig and wondered, “What about milk?”

More than two years ago, I read this article in The New York Times about the growing market for raw milk, as opposed to the pasteurized variety available in stores.

Pasteurization involves heating and quickly cooling milk to kill pathogens such as E. coli and salmonella.

Raw milk drinkers, however, argue that the process also destroys beneficial bacteria, proteins and enzymes that contribute to a stronger immune system and better digestive health.

Interstate sales of raw milk were banned 20 years ago by the Food and Drug Administration, but regulation is up to the states.

In Colorado, the sale of raw milk is illegal but the “work around” is to buy a share of a cow. In compensation for paying the bovine’s room and board, shareholders receive milk.

I was drawn to the idea for several reasons. I keep learning about more and more people my age suffering from nebulous immune disorders, which, it is theorized, can result from growing up in an overly sanitized environment. Because the body doesn’t know benign bugs from bad ones, it can’t respond appropriately. See this entry on The New York Times’ Well blog for more about that. So there’s certainly a parsimony of logic to me in the raw-milk-equals-good-bacteria-equals-better-health argument.

Then there’s the environmental argument. Even when I buy organic milk, it still comes from cows that reside who knows where. It has to be put in plastic jugs and driven hundreds of miles to my store. I recycle the jugs but that still consumes resources in transportation and processing.

Finally, there’s keeping it local. I want my consumer dollar going to someone I’ve met, in the community where I live.

So with this impetus, I started to investigate. According to realmilk.com, there are two raw milk providers in the Durango area, Nativo Farms and James Ranch. I called both and had all my questions answered with utmost friendliness and helpfulness. James Ranch’s cow share program is a little more costly and closes down in the winter. Nativo Farms is operating for the first time through the winter this year. So two weeks ago I signed the contract and made my first pick-up at Nativo Farms, located a couple miles south of Elmore’s Corner. (Nativo Farms now has a waiting list, according to the Web site).

This is how the economics broke down: for a one-time payment of $5, a $5 bottle fee and a $39 monthly fee for a share and half, we get a gallon and a half of raw milk a week. After start-up, it breaks down to not much more than I was paying for the organic stuff at the grocery store.

Raw milk enthusiasts have described the taste as richer, creamier and more complex. Personally, since we already were drinking whole milk, I didn’t find it much different in thickness or richness. But there is an extra dimension that is difficult to describe. It’s like milk, but more vividly, more intensely so. My 3-year-old seems oblivious to any nuanced flavor differences and chugs it with the same happy abandon as the store-bought stuff.

I won’t argue that pasteurization hasn’t played a valuable public safety role, but I think it comes down to the farm and the farmer. I’d rather trust a person I can meet and a place I can see than a faceless industry. But maybe that’s just the addict in me speaking.

Thursday: In-school vaccination clinics in Miller Middle School and Ignacio junior and senior schools.

Friday: In-school vaccination clinics in Bayfield and Durango high schools.

Saturday: 4:30-7 p.m., La Plata County Fairgrounds Extension Building.

Populations: Children 14 years and younger*; people as old as 64 with chronic health conditions; pregnant women; parents, siblings or day care providers of children 6 months and younger.

*Call San Juan Basin Health to find out if vaccine availability has expanded additional eligible populations. FluLine: 247-5702 ext. 1520. Web site, www.sjbhd.org.

Tylenol lowers vaccine immunity when given to babies

by Marilynn Marchione
AP Medical Writer

Giving babies Tylenol to prevent fever when they get childhood vaccinations may backfire and make the shots a little less effective, surprising new research suggests.

It is the first major study to tie reduced immunity to the use of fever-lowering medicines. Although the effect was small and the vast majority of kids still got enough protection from vaccines, the results make “a compelling case” against routinely giving Tylenol right after vaccination, say doctors from the U.S. Centers for Disease Control and Prevention.

They wrote an editorial accompanying the study, published in the British medical journal Lancet.

The study only looked at preventive use of Tylenol – not whether it is OK to use after a fever develops.

Tylenol or its generic twin, acetaminophen, is recommended widely as a painkiller for babies. Many parents give it right before or after a shot to prevent fever and fussiness, and some doctors recommend this. The CDC’s vaccine advisory panel says it is a reasonable thing to do for children at high risk of seizures, which can be triggered by fevers.

However, fever after a vaccine isn’t necessarily bad – it’s a natural part of the body’s response. Curbing fever, especially the first time a baby gets a vaccine, also seems to curb the immune response and the amount of protective antibodies that are made, the new study found.

It was led by military and government scientists in the Czech Republic and was done at 10 medical centers in that Eastern European country. It involved 459 healthy infants, 9 to 16 weeks old, who were getting vaccines against polio, pneumonia, meningitis, whooping cough, tetanus, hepatitis and other childhood diseases.

Half were given three doses of Calpol, or paracetamol – a Tylenol-like brand sold in Europe – during the first day after vaccination. The others were given nothing besides the vaccines. Babies given the painkiller were significantly less likely to develop a fever, but lower rates of protective antibody levels from several vaccines were seen in that group.

The Durango clinics will take place 4-6 p.m. Wednesday, Nov. 4, and 10 a.m.-noon Saturday, Nov. 7. Both clinics will be held at San Juan Basin Health Department in Bodo Park.

The Bayfield clinic will take place 4-6 p.m. Thursday, Nov. 5, at the Upper Pine Fire Protection Administration Building located at 515 Sower Dr.

On Friday, Nov. 6, San Juan Basin Health will be providing H1N1 vaccines 9 a.m.- 2 p.m. the health fair inside the Sky Ute Casino.

These clinics are ONLY for: individuals up to age 64 with chronic health conditions, pregnant women, children 6 months to 4 years old, and for parents, siblings or daycare providers of babies under six months old. Both FluMist and shots will be available.

Vaccinations are free; however, people may make a voluntary donation.

San Juan Basin Health will be adding clinics weekly. Visit their website, www.sjbhd.org, or call FluLine 247-5702, ext. 1520 for more information. You can also the La Plata County Infoline at 385-INFO (4636), ext. 2270 or the Colorado Helpline at (877) 462-2911.

FLU ACTIVITY: The number of cases fluctuated this week. There was an increase in reported flu-like illness absences in Durango 9-R schools and a decrease in Bayfield schools.

“Among children aged 6 months to 35 months just one in four had a strong immune response after 21 days. For those 3 years to 9 years old it was 55 percent. There was a sharp improvement after a second dose …”

WASHINGTON (AP) — A single dose of the swine flu vaccine works well for almost all pregnant women, but young children will still need two doses for best results, federal health officials said Monday.

Twenty-one days after receiving a single 15-microgram dose of the vaccine, 92 percent of pregnant women showed a robust immune response, Dr. Anthony Fauci reported.

A larger, 30-microgram dose produced a strong response in 96 percent of pregnant women, said Fauci, director of the National Institute of Allergy and Infectious Disease.

“This should be reassuring news to those women who have received the vaccine,” Fauci said.

While a single dose is recommended for healthy adults and pregnant women, officials have said younger children will need two doses.

That has been confirmed by continuing studies, Fauci said.

He said among children aged 6 months to 35 months just one in four had a strong immune response after 21 days. For those 3 years to 9 years old it was 55 percent. There was a sharp improvement after a second dose, he said, raising the fully protected rate to 100 percent in those 6 months to 35 months and 94 percent in those aged 3 years to 9 years.

Giving the larger 30 microgram dose gave no added benefit, Fauci said.