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Johnson & Johnson Recalls Children's Tylenol and Motrin

May 13, 2010 | 50,419 views

tylenol, motrin, zyrtec, recall, johnson & johnsonThe U.S. FDA has urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec medicines for children and infants. Johnson & Johnson has announced a broad recall following the discovery of manufacturing deficiencies that could affect the quality, purity and potency of the drugs.

The FDA also warned that consumers should not give adult strength medicine to children instead, as this can result in serious harm.

According to Reuters:

“Some of the products affected by the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”

 

Dr. Mercola's Comments:

I remember when I was in my family practice residency in Chicago, in October of 1982, when seven people were killed because someone tampered with Tylenol and laced it with cyanide.

This was a serious problem and Johnso and Johnson handled the crisis so well they are frequently studied in business schools for how to respond to a crisis like this. However, that instance wasn’t their fault,as they were the victim of tampering. The event did trigger a change in all the packaging though, to prevent similar copycat crimes in the future.

But. on April 30, 2010, McNeil Consumer Healthcare, a division of Johnson and Johnson, voluntarily recalled all unexpired lots of certain over-the-counter pediatric drugs, including Tylenol, Motrin, Zyrtec and Benadryl products. A full list of the products affected by the recall can be found at this link.

As a result, the US Food and Drug Administration (FDA) is urging parents to stop using any of the liquid formulas for their children, as the manufacturer has discovered “manufacturing deficiencies that could affect the quality, purity or potency of the medicines.”

Amazingly, it’s been less than a year since these same types of OTC drugs were previously recalled, which would cause any health conscious consumer to wonder about the overall quality control and safety of these medicines.

The last recall occurred in September of last year, when 21 children’s and infant’s Tylenol liquid products were deemed potentially unsafe due to bacterial contamination found in one of the inactive ingredients.

This time, the quality control issues appear to be even more problematic, as the recalled products may contain either:

  1. Higher concentration of active ingredient than specified
  2. Inactive ingredients that may not meet testing requirements
  3. Tiny particles of unspecified origin

The products were allegedly manufactured in the United States, and distributed within the US as well as the following countries:

Canada

The Dominican Republic

Dubai

Fiji

Guam

Guatemala

Jamaica

Puerto Rico

Panama

Trinidad

Tobago

Kuwait

All in all, a total of 40 liquid children’s and infant’s products are affected.

Potentially Dangerous AND Ineffective… Why are they Still on the Market?

That’s right, not only do even the most widely recognized brands have quality control issues, as this second recall within a twelve-month period attests to, but there are also two additional, more insidious problems with these types of products.

First, many still do not realize that over-the-counter (OTC) drugs can be just as harmful as prescription drugs, and second, few have any idea of just how ineffective they are!

As with so many other drugs, OTC medicines can easily lean toward having a higher risk than benefit ratio.

In 2007, an FDA advisory panel actually voted to ban OTC cold products intended for children under the age of six.

The reason for the recommended ban was because there is no proof the products work!

There is evidence, however, that they can cause serious harm.

The FDA ended up revising this stance, and now recommends that OTC cough and cold products not be used for children under the age of two.

They also state that you need to understand that “using OTC cough and cold medicines are intended only to treat your child’s symptom(s). OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable.” [Emphasis mine.]

Meanwhile, studies conducted on the effectiveness of cough and cold medicines on adults, while inconclusive, have raised the question about whether or not it’s necessary to suppress or “cure” a cough in the first place.

There is a common perception that if you’re coughing, sneezing or have a low-grade fever, you must take a medication to get rid of it. In reality, coughing and sneezing are tools your body uses to get rid of viruses and irritants, and fever also helps to kill bacteria and viruses.

So by taking a drug to stop these natural protections, you are actually impairing your body’s ability to fight the infection, which will result in significantly delaying the healing process.

Why You Don’t Want to Mask Your Child’s Symptoms

As expressed above, OTC medications, like all drugs, simply mask symptoms. They do not address the underlying cause of the problem.

Many of the products that were recalled are used to treat a child’s fever. But what many parents don’t realize is that a fever is actually a good thing.

Childhood fevers are in fact better than any vaccination at triggering an authentic, life-long immune response in your child’s body.

A basic fever, one due to minor bacterial or viral illness, can be an expression of the immune system working at its best. It increases both the amount of interferon (a natural antiviral and anticancer substance) in your blood, and the amount of white blood cells, which kill infected cells. Fever also impairs the replication of many bacteria and viruses.

Therefore, when you suppress your child’s fever with Tylenol or other medications, you can cause far more harm than good. In fact, animal studies have shown that when fever is blocked, survival rates from infection decline.

For more in-depth information about fevers, please review the previous article, Fever in Children - A Blessing in Disguise.

I advise avoiding all anti-fever medications unless your child is absolutely miserable or the fever is over 104o F.

In fact, I strongly encourage you to do the research before giving your child any medication, and only do so if there is truly no other option (you may need to seek out the opinion of a doctor who is knowledgeable about natural medicine).

Home Management of Fevers

Many are confused about how to judge when their child is truly ill and in need of medical attention. This results in countless needless visits to the doctor and/or emergency room each year.

These questions can help you determine whether or not it would be best to treat your child at home, or prudent to see a doctor:

  • Is your child drinking fluids well?
  • Urinating at least once every eight hours (ideally, every three to four hours, or wetting eight to ten diapers per day)?
  • Does your touch console her?
  • Is she playing normally?

If the answer to these questions is yes, she is probably not seriously ill.

Nondrug approaches can go a long way toward helping your child feel better. If the situation does not seem urgent, you might want to consider a trial of herbal treatment before you pull out the acetaminophen. A tepid bath can also be a soothing, effective alternative for symptom relief.

Other strategies to manage your child’s fever at home include:

  • Do give your child lots to drink. Fever increases fluid loss, and dehydration can drive up your child's temperature. Kids with fever often do not feel thirsty, or by the time they do, they're already dehydrated. So keep offering fluids.

  • Small, frequent sips are often best, especially if the child feels nauseated. If necessary, use a plastic medicine dropper to gently insert water into your child's mouth.

  • Dress lightly or bundle? The answer depends on your children's perception of temperature - follow her cues.

    If your child looks pale, shivers, or complains of feeling chilled (things that tend to happen in the early stages of fever), bundle her in breathable fabrics so that sweat will evaporate, but make sure she can easily remove the layers. If she is comfortable and her fever is low, dress her snuggly and give warm liquids to assist the body's fever production.

    If she sweats and complains of heat, dress her lightly and let her throw off the covers. Older kids will take care of these needs themselves.

  • Don't push food. People with fevers generally don't have much appetite. Let your child determine when and what she eats. Just bear in mind that consumption of sugary foods could delay the natural immune response.


[+] Sources and References

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