Kids, Colds, And OTC Meds

 

 

# 5878

 

With cold and flu season on the way, this is probably a good time to remind my readers that the CDC and the FDA continue to warn parents over the use of many over-the-counter (OTC) cough and cold medications in young children.

 

In January of 2008 the FDA issued a warning to parents that OTC cough and cold remedies were no longer considered to be safe or effective for children  under the age of 2.

 

Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age

FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

(Continue . . . )

 

 

Despite this announcement, the debate over the safety and effectiveness of these same medications for older children continued, with some experts calling to ban their use for children under the age of 6.

 

In a bit of a pre-emptive strike, in the fall of 2008 the CHPA (Consumer Healthcare Products Association ) announced that its members were voluntarily modifying the product labels on many of their OTC meds to state "do not use" in children under 4 years of age. 

 

Despite these recommendations, and the publicity they generated, old habits apparently die hard.

 

Earlier this year the C.S. Mott Children’s Hospital National Poll on Children’s Health indicated that for a majority of parents, those warnings are going unheeded.

 

 

The following excerpts are from the University of Michigan Health System’s press release:

 

February 14, 2011

ANN ARBOR ,Mich.

Parents continue to give cough and cold meds to young kids, despite FDA warnings

Research has linked over-the-counter cough and cold products to poisoning or death in hundreds of children, ages 2 and younger. Studies have also shown that these medicines do little to control symptoms. As a result, in 2008, the United States Food and Drug Administration formally recommended that OTC cough and cold products not be given to children under age 2.

 

A poll released today by the C.S. Mott Children’s Hospital National Poll on Children’s Health shows that 61-percent of parents of children, ages 2 and younger, gave their children OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child’s doctor says OTC cough and cold medications are safe for children under 2; half of their physicians said they are effective.

(Continue . . . )

 

 

For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse  to `do something’ to alleviate their misery is strong.   

 

But all medicines . . . even those available over-the-counter – have risks.  And for very small children, the FDA and the CDC  believe those risks outweigh any benefit they might derive from these types of products.

 

This from the CDC.

 

Cold and Cough Medicines: Information for Parents

It's winter, and parents may be tempted to reach for over-the-counter medicines to ease their child's sniffling and coughs. But recent safety concerns have prompted drug manufacturers to change their labels stating that cough and cold medicines should NOT be given to children younger than age 4. Parents can take some steps now to help keep their children safe.

 

Each year, thousands of children under age 12 go to emergency rooms after taking over-the-counter cough and cold medicines. Most of these children were unsupervised when they took the medicine.

 

In response to safety concerns, the leading manufacturers of children's cough and cold medicines are voluntarily changing the labels on these products to state that they should not be used in children younger than 4 years of age.

(Continue . . .)

 

Adding to the risks, in December of 2010 we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the dangerously ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.

 

And in August of last year (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.

 

The question remains, what can a parent do to help relieve their child’s symptoms without resorting to potentially harmful OTC meds?

 

Again the CDC has some suggestions that may help.

 

Symptom Relief

• How to Feel Better
• Over-the-Counter (OTC) Medicines
• Questions and Answers for Parents about Over-the-Counter (OTC) Medicines
• Related Materials

CMAJ: Childhood Flu Vaccinations Reduced Hospitalizations

 

 

# 5855

 

 

From the CMAJ (Canadian Medical Association Journal) we get the results of a comparative study between the United States – which expanded its recommendations for seasonal influenza vaccination to include healthy children aged 24–59 months in 2006-07, and Canada which did not follow suit.

Using data collected on ER visits by children in two pediatric hospitals  located in Boston, Massachusetts & Montréal, Quebec over a period of 9 years, they were able to compare the rates of influenza-like-illness (ILI) among children both before and after the U.S. vaccine policy change went into effect.

 

What they found was that relative to Canada, the U.S. saw a 34% reduction in ILI among children aged 2-4 since the new vaccine recommendations were instituted.

 

The research paper is available on the CMAJ website:

 

Effect of expanded US recommendations for seasonal influenza vaccination: comparison of two pediatric emergency departments in the United States and Canada

Anne Gatewood Hoen, PhD, David L. Buckeridge, MD PhD, Katia M.L. Charland, PhD, Kenneth D. Mandl, MD MPH, Caroline Quach, MD MSc, John S. Brownstein, PhD

 

Interpretation: The divergence in influenza rates among children in the US and Canadian sample populations after institution of the US policy to vaccinate children two to four years of age is evidence that the recommendation of the US Advisory Committee on Immunization Practices resulted in a reduction in influenza-related morbidity in the target group and may have indirectly affected other pediatric age groups. Provincial adoption of the 2010 recommendation of the National Advisory Committee on Immunization in Canada to vaccinate children two to four years of age might positively affect influenza morbidity in Canada.

 

 

For more details, we get this press release from Children’s Hospital in Boston.

 

 

'Natural experiment' documents the population benefit of vaccinating preschoolers against the flu

Flu rates among two- to four-year-olds decline 34 percent following changes in U.S. vaccine policy; study is first to use real time hospital data to evaluate policy change

Boston, Mass. – Recent policies calling for vaccinating preschool-aged children against the flu led to a 34 percent decline in influenza cases in this age group, according to researchers at Children's Hospital Boston and McGill University. The findings, which revealed smaller declines in other age groups as well, arose from a study that used real time surveillance data from pediatric emergency departments (EDs) in the United States and Canada to evaluate the relationship between national flu vaccination policies and rates of flu-like illness.

 

The research team, led by Anne Gatewood Hoen and John Brownstein of the Children's Hospital Informatics Program (CHIP), reported their findings September 19 in the Canadian Medical Association Journal.

 

Preschoolers – specifically children aged two to four – play a significant role in community transmission of the flu with each new season. The Advisory Committee on Immunization Practices – the national body that sets vaccination policies in the U.S. – updated its influenza vaccine recommendations in 2006 to include vaccination of this age group. The corresponding Canadian body, the National Advisory Committee on Immunization, did not include these children in its recommendations until 2010.

 

"The differences in the U.S. and Canadian policies created conditions for a natural experiment for evaluating the effects of U.S. policy change in the target age group," said Brownstein, director of CHIP's Computational Epidemiology Group. "They also gave us an opportunity to test whether we could use hospital-based real time surveillance data to assess the effects of policy changes, and do so more quickly than traditional epidemiologic studies, which are more focused on vaccine uptake than on outcomes."

(Continue . . . )

 

 

As always, there were some limitations to this study. First, it was only conducted at two hospitals, which might not accurately reflect national trends.

 

Second,  that influenza diagnoses were rarely confirmed by lab tests, but were rather based on symptoms of ILIs (influenza-like-Illnesses). The authors state, however, that:

 

Repeating our analysis with a narrower definition of influenza-like illness resulted in a strengthening of the effect from a 34% reduction to  a 52%  reduction in  emergency department visits for influenza-like illness at Children’s Hospital Boston relative  to  the Montreal Children’s Hospital, which suggests that our broad definition resulted in a conservative  estimate of  the effect.

 

And third, data on vaccine uptake for each patient was not generally available, and instead the authors relied upon surveys of vaccination rates among children during the years in question.

 

Still, despite these limitations, this study provides strong evidence to support to the policy of vaccinating young children against seasonal influenza. 

 

With influenza season soon upon us, the CDC  would like to see just about everyone over the age of 6 months get the flu vaccine. 

 

For details on this year’s recommendations see:

 

MMWR: ACIP Updated Flu Vaccination Recommendations

 

The CDC also provides a parent’s guide with information on the danger signs in children, and advice on vaccination.

NIH: Any Combo Of Prime-Boost Flu Vaccine Protects Toddlers

 

 

# 5759

 

 

Children 6 months of age or older, who have never received a flu vaccine before, are recommended to receive a priming vaccine and a booster – one month apart – the first time.

 

For children over the age of 6 months, the TIV flu shot may be used, and for healthy children 24 months or older, the LAIV nasal spray may be substituted.

 

Until now, a lack of clinical studies have left some doubts as to whether a combination of the TIV flu shot and LAIV nasal vaccine would perform equally as well.

 

From the NIH today, we’ve a report on clinical trials conducted at Saint Louis University, along with investigators at Vanderbilt University in Nashville, and the Cincinnati Children's Hospital – funded by NIAID -that looks at the immune responses in toddlers who received one of four different flu shot combinations:

 

• two injections of a TIV vaccine
• two LAIV nasal spray vaccines
• A LAIV nasal spray followed by a TIV shot
• a TIV shot followed by the LAIV nasal spray

 

The good news . . . particularly for children at least 2 years of age with an aversion to needles . . . is that two sprays of the LAIV vaccine appear to produce the same level of antibody response as two flu shots.

 

And when a child receives at least one of their vaccines via the LAIV nasal spray, they produced a wider array of immune T cells, which may help protect against other flu strains.

 

This from NIH News.

 

 

Any Prime-Boost Mix of Injected or Spray Flu Vaccine Shields Toddlers

Broadest Immune Response from Nasal Spray Vaccine, NIH-Funded Study Finds

Children younger than 3 years old receive the same protective antibody response from the recommended two doses of licensed seasonal influenza vaccines regardless of whether the two doses are injected by needle, inhaled through a nasal spray or provided through one dose of each in any order, according to researchers funded by the National Institutes of Health. Doctors usually give young children two matching vaccines, and one goal of the study was to determine whether giving two different types of vaccines works just as well.

Daniel Hoft, M.D., Ph.D., conducted a trial of influenza vaccines in young children.
Credit: Saint Louis University

 

<SNIP>

 

The researchers found that all four dosing patterns were safe and induced similar levels of protective antibodies. However, when the investigators looked at responses from the T-cell arm of the immune system, a striking difference emerged. They could not detect influenza-specific T cells in children who received only TIV, according to Dr. Hoft. But, he added, “The kids who received at least one dose of LAIV nasal spray vaccine produced significant amounts of three important T-cell subtypes that are likely to confer additional protection beyond that afforded by antibodies alone.”

 

Previous studies have demonstrated that children are better protected against influenza infection and disease by LAIV than by TIV, Dr. Hoft noted. However, few studies have examined the T-cell responses elicited by LAIV when given to very young children who have little prior natural exposure to seasonal influenza viruses. Distinguishing T-cell responses due to vaccination from those arising after natural exposure to influenza virus becomes more difficult as a child ages, he explained. Because the children in the trial were all younger than 3 years old, the researchers could be confident that spikes in levels of the three T-cell subtypes they detected were likely due to the vaccinations.

 

Children who received only one dose of LAIV had T-cell responses similar to those who received two, and the order of vaccine types did not make a significant difference in the size of the T-cell response. However, because LAIV has sometimes been associated with increased incidence of wheezing in the youngest recipients, the results of this trial suggest that the best regimen for kids younger than 24 months may be TIV followed by LAIV, Dr. Hoft said. Larger clinical trials are required to confirm the safety and efficacy of such an approach, he added. 

 

(Continue . . . )

 

The results are published today in the Journal of Infectious Diseases, and the abstract may be read at:

 

Live and Inactivated Influenza Vaccines Induce Similar Humoral Responses, but Only Live Vaccines Induce Diverse T-Cell Responses in Young Children

Daniel F. Hoft, Elizabeth Babusis, Shewangizaw Worku, Charles T. Spencer, Kathleen Lottenbach, Steven M. Truscott, Getahun Abate, Isaac G. Sakala, Kathryn M. Edwards, C. Buddy Creech, Michael A. Gerber, David I. Bernstein, Frances Newman, Irene Graham, Edwin L. Anderson and Robert B. Belshe

Poll: Despite FDA Warning Parents Use OTC Cold Remedies For Kids Under 2

 

 

 

# 5319

 

In January of 2008 the FDA issued a warning to parents that OTC (over-the-counter) cough and cold remedies were no longer considered to be safe or effective for children  under the age of 2.

 

 

Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age

FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

(Continue . . . )

 

Despite these recommendations, and the publicity they generated, old habits apparently die hard.

 

 

Three years later the C.S. Mott Children’s Hospital National Poll on Children’s Health indicates that for a majority of parents, those warnings are going unheeded.

 

 

 

The following excerpts are from the University of Michigan Health System’s press release:

 

February 14, 2011

ANN ARBOR ,Mich.

Parents continue to give cough and cold meds to young kids, despite FDA warnings

Research has linked over-the-counter cough and cold products to poisoning or death in hundreds of children, ages 2 and younger. Studies have also shown that these medicines do little to control symptoms. As a result, in 2008, the United States Food and Drug Administration formally recommended that OTC cough and cold products not be given to children under age 2.

 

A poll released today by the C.S. Mott Children’s Hospital National Poll on Children’s Health shows that 61-percent of parents of children, ages 2 and younger, gave their children OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child’s doctor says OTC cough and cold medications are safe for children under 2; half of their physicians said they are effective.

 

(Continue . . . )

 

 

Particularly concerning is the assertion by roughly half of the parents that their healthcare providers continue to recommend these products for their children under the age of 2.

 

The safety and effectiveness of OTC cold remedies for children between the ages of 2 and 6 is still under review by the FDA.  

 

Complicating matters, in December we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.

 

And in August 2010 (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.

 

For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse is to `do something’ to alleviate their misery is strong.   

 

But all medicines . . . even those available over-the-counter – have risks.  And for very small children, the FDA believes those risks outweigh any benefit they might derive from these types of products.

UK: DOH Advises CSL/Pfizer Flu Vax Not For Under Five’s

 

 

# 4771

 

 

CSL, Ltd produces influenza vaccines for Australia, and for export to other countries.  In some cases those vaccines are marketed - and re-labeled – by other companies.

 

The UK is among the importers of CSL’s flu vaccine, which earlier this year was been linked to a higher than normal incidence of febrile side effects in children under the age of five.  

 

Pfizer markets the CSL vaccine under the name Enzira while CSL Biotherapies sells it as a generic influenza vaccine.

 

Doctors in the UK are being urged by the DOH to use the CSL/Pfizer vaccines for those over the age of five.

 

Healthcare Republic has the story at the link below.  

 

Flu jabs from CSL and Pfizer not for under fives, DoH warns

Tom Moberly, healthcarerepublic.com, 29 July 2010, 10:49am

 

 

You’ll I posted another story on the CSL vaccine earlier today in  Australia Lifts Ban On Flu Vax For Under Five’s.

Study: Vaccinating Kids Promotes Herd Immunity

 

 

# 4416

 

 

The recent push to vaccinate children against seasonal influenza every year is based, in part, on the idea that kids are very efficient spreaders of the virus – and that if you can reduce their susceptibility to infection – you can reduce the influenza burden on the entire community.

 

Today we’ve a new study out of Canada that seems to support this theory, suggesting that vaccinating kids helps protect the entire community.

 

Helen Branswell of the Canadian Press brings us the details, and I’ve included the NIAID press release as well.   Follow the link to read Helen’s article in its entirety.

 

 

Want to reduce amount of flu in adults? Vaccinate kids, study shows

By Helen Branswell Medical Reporter (CP) – 2 hours ago

TORONTO — A landmark study looking at how to limit the spread of influenza has shown what experts have long believed but hadn't until now proved: Giving flu shots to kids helps protect everyone in a community from the virus.

 

The study, led by Dr. Mark Loeb of McMaster University in Hamilton, Ont., showed the risk of catching the flu was lowered by nearly 60 per cent in communities where a substantial portion of kids aged three to 15 got flu shots.

 

That level of indirect protection is nearly as good as what healthy adults might expect from getting a flu shot themselves and is perhaps better than what a senior with a waning immune system might expect from a flu vaccination.

(continue . . .)

 

 

Vaccinating Children against Flu Helps Protect Wider Community

Trial Results in Rural Canadians Show Effect of Herd Immunity

WHAT:

Results of a clinical trial conducted in a largely self-contained religious community during the 2008-09 influenza season show that immunizing children against seasonal influenza can significantly protect unvaccinated community members against influenza as well. The study was conducted to determine if immunized children could act as a barrier to limit the spread of influenza to the wider, unvaccinated community, a concept known as herd immunity.

 

Researchers recruited volunteers from 46 Canadian Hutterite religious colonies that have limited contact with surrounding, non-Hutterite populations. A total of 947 children between 36 months to 15 years of age participated in the trial; 502 children in 22 colonies received 2008-09 seasonal influenza vaccine, while 445 youth in the other colonies received hepatitis A vaccine. The hepatitis A vaccine served as a control vaccine for comparison.

 

In the six months after the children were vaccinated, 119 of 2,326 unvaccinated community members (who were of all ages) developed laboratory confirmed cases of influenza. Of these, 80 of 1,055 were from colonies where children received hepatitis vaccine, while 39 of 1,271 were from colonies where children received the influenza vaccine.

 

The researchers found that influenza vaccination was 61 percent effective at indirectly preventing illness—that is, protecting via herd immunity—in unvaccinated individuals if they lived in a colony where approximately 80 percent of the children had received flu vaccine. The findings, they write, “...offer experimental proof to support selective influenza immunization of school aged children…to interrupt influenza transmission. Particularly, if there are constraints in quantity and delivery of vaccine, it may be advantageous to selectively immunize children in order to reduce community transmission of influenza.”

 

Mark Loeb, M.D., of McMaster University, Hamilton, Ontario, led the trial. The research was funded in part by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and by the Canadian Institutes for Health Research.

 

Visit the NIAID Web site to see an illustration showing how vaccination generates herd immunity. 

ARTICLE:

M Loeb et al. Effect of influenza vaccination of children on infection rates in Hutterite communities. JAMA 303:943-50 DOI: 10.1001/jama.303.10.943 (2010).

 

 

 

Credit NIAID

IDSA: Kids Shed Virus Longer Than Adults

 

# 3913

 

 

More evidence, presented at the IDSA (the Infectious Diseases Society of America) in Philadelphia this week, indicating that children shed the influenza virus longer than adults.  

 

This isn’t the first time we’ve heard this sort of data (see Swine Flu: The Gift That Keeps On Giving).

 

The guidance from the CDC for staying home, and not going to work or school, has been scaled back from at least 7 days or 24 hours after symptoms disappear – to 24 hours after fever is gone (without using fever reducing drugs).  

 

Which means that some people may be returning to work or school following an illness while still shedding the virus.

 

Whether this really makes much of a difference is debatable. 

 

Shedding enough virus to be detectable by today’s modern RT-PCR testing or culture, and being contagious and able to spread the virus, may be two entirely different propositions.  

 

It it is believed that people can shed the flu virus for to 24 hours before ever showing symptoms – and that some may carry the virus asymptomatically, and spread the virus to others - without ever falling ill themselves (see They Walk Among Us ).

 

All of which makes it virtually impossible to keep the virus out of the schools and workplace.  Since you can’t tell who is shedding the virus and who isn’t, the only real defense is to get vaccinated, and to practice good flu hygiene. 

 

This report from Medpage Today.

 

 

IDSA: Kids Shed H1N1 Flu Longer than Adults

By Michael Smith, North American Correspondent, MedPage Today
Published: October 30, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

 

PHILADELPHIA -- Children appear to shed particles of the H1N1 pandemic flu virus longer than adults do, which may have implications for how long they stay out of school, a researcher said here.

 

The finding comes from an analysis of an outbreak in a Pennsylvania elementary school in May and June, according to Achuyt Bhattarai, MD, of the CDC.

 

Analysis of a series of specimens from affected children and their household contacts also showed that younger children tended to shed the virus longer than older kids, Bhattarai told attendees at the annual meeting of the Infectious Diseases Society of America.

(Continue . . .)

Dutch Researchers Question Flu Vaccinations For Kids

 

 

# 3908

 

On the same day that the NIAID study comes out promoting the idea of increased childhood vaccinations to slow antigenic drift of flu viruses (see NIAID Scientists Propose New Explanation for Flu Virus Antigenic Drift ) we get blindsided by a new, contrarian study, that questions the wisdom of vaccinating kids against seasonal flu.

 

Helen Branswell, medical reporter for The Canadian Press, gives us a terrific overview of the controversy.   Follow the link to read it in its entirety.

A hat tip to Crof on Crofsblog  for posting this story.

 

 

 

Do seasonal flu shots impede little kids' ability to fight off pandemic flu?

By Helen Branswell Medical Reporter (CP)

TORONTO — Just when you thought the issue of seasonal and pandemic flu shots couldn't get any more confusing, European researchers are questioning whether it makes sense to vaccinate little kids against seasonal flu.

 

The scientists, from the Erasmus Medical Center in Rotterdam, the Netherlands, argue preventing small children from being infected by - and developing immune responses to - seasonal flu viruses might make them more vulnerable when a flu pandemic rolls around.

 

It's not clear the theoretical concern they raise is true. But other scientists counter that even if it is, it makes more sense to try to protect children from a threat they face every year than one they might face every few decades.

 

"The simple question is should we let young children suffer from a severe and potentially fatal but easily preventable illness, just because there is a theoretical possibility that withholding vaccination might result in a slightly less severe illness sometime in the future?" a pair of Finnish researchers retorted in a counterpoint published with the perspective piece, in the journal Lancet Infectious Diseases.

 

(Continue . . . )

 

The study causing all of the commotion is from the Lancet:

 

 

doi:10.1016/S1473-3099(09)70263-4 

Yearly influenza vaccinations: a double-edged sword?

Original Text

Rogier Bodewes DVM , Joost HCM Kreijtz PhD, Dr Guus F Rimmelzwaan PhD

Summary

Yearly vaccination against seasonal influenza viruses is recommended for certain individuals at high risk of complications associated with influenza. It has been recommended in some countries, including the USA, that all children aged 6—59 months are vaccinated against seasonal influenza. However, it has been shown—mainly in animals—that infection with influenza A viruses can induce protective immunity to influenza A viruses of other unrelated subtypes.

 

This so-called heterosubtypic immunity does not provide full protection, but can limit virus replication and reduce morbidity and mortality of the host. This type of immunity might be relevant to human beings when a new subtype of influenza A virus is introduced into the population, such as the new influenza A H1N1 virus responsible for the present influenza pandemic and the highly pathogenic avian influenza H5N1 viruses that are causing an ever increasing number of human infections with high mortality rates. Preventing infection with seasonal influenza viruses by vaccination might prevent the induction of heterosubtypic immunity to pandemic strains, which might be a disadvantage to immunologically naive people—eg, infants.