Tag Archives: medicine

Cold Drugs and Children

According to the Washington Post on January 29, 2008 (article here), more than 7000 children per year get rushed to emergency rooms due to adverse reactions to cough/cold medicines. According to the article, most of the problems occur in children ages 2-5, who got into the medicine on their own.

The researchers based their conclusions on information from a “nationally representative sample of 63 emergency rooms in 2004 and 2005.” This is coming as the FDA considers whether to further restrict the use of these products. The issues are the risks involved and the possibility that the products simply aren’t effective in young children.

Pediatricians are arguing that the drugs are not effective in young children and pose too great a risk to continue to allow their usage; the Consumer Healthcare Products Association, an industry group, says that the report shows that the problem really lies in parents giving incorrect dosages or failing to make sure the medicine is out of the reach of children. Last year, the industry voluntarily withdrew all products marketed for children under the age of two, but insisted that the products were safe for children older than 2.

The CDC said that last year at least “1500 children younger than 2 had complications in 2004 and 2005 from the products, and an FDA review noted dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 123 deaths.”

In terms of this most recent information, the researchers identified 301 cases between January 1, 2004, and December 31, 2005. “Cold and cough drugs account for 5.7 percent of all medicine-related visits to the emergency room by children younger than 12. The cases did include prescription and OTC products, but researchers said that most of them involved nonprescription products.

Nearly 80 percent of the cases in the ages 2-5 involved situations in which children got into the medicine without their parents’ knowledge.

Basically, the researchers recommended several steps to make the products safer and reduce the risk. Examples include: encouraging parents to put the medicines out of the reach of children, to encourage them to keep them capped, designing better child-proof containers, and also avoiding the use of colors that make products appealing to children.

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Ok, what I really want to know here is this: are the products effective or not? I can certainly take care of keeping the products out of the reach of my children and make sure the caps are on good, but I don’t want to use them if they aren’t going to help!

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Researchers say to drink and exercise

Now here is a study I can get behind! According to Danish researchers, “drinking is healthy, exercise is healthy, and doing a little of both is even healthier.” This is according to an article published by Reuters on January 8, 2008 (here).

Obviously, you are not supposed to go out and get drunk every night – that is most definitely NOT healthy and not what is being touted by doctors. Rather, a drink or two regularly in addition to regular exercise is a healthy way of life.

According to the article, people who neither exercise nor drink have a 30-49 percent higher risk of heart disease than those who do one or both of the activities, according to a report in the European Heart Journal. “Several major studies have found that light to moderate drinking – up to two drinks a day on a regular basis – is associated with a lower risk of heart disease, and some have also found this leads to a lower risk of some cancers.” The Danish study, though, is the largest of its kind to examine the combined effect of drinking and exercise, and it found there were additional benefits from doing both things. Non-drinkers had a 30-31 percent higher risk of heart disease compared to moderate drinkers, regardless of the level of activity. Moderate consumption of alcohol was defined as up to 2 drinks per day (1-14 drinks per week). Teetotalers were able to reduce their risk of heart disease by exercising at least moderately. The people with the lowest risk of dying from any cause were those who performed both activities while those at the highest risk were those who were physically inactive, heavy drinkers.

Just something to think about…and of course, you do have to wonder if a study next week or next month will find the opposite. My husband’s doctor did indeed recommend a drink a day for health benefits; he gets a kick out of telling people that he’s having a drink due to doctor’s orders.

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More on Children’s Cold Remedies

If you’ve been following the news lately (and the articles I’ve posted references to in this blog), children’s cold remedies are under fire. Now it turns out that they have been “raised questions for years”, according to the Washington Post. (Here, for now). This article was in the Post on Friday, October 26, 2007.

This situation has raised a number of questions (from the article):

  • How could the products remain on the market so ling without proof that they work?
  • Why didn’t the FDA act sooner?
  • Why didn’t the medical establishment warn parents?

It seems that about two-thirds of drugs prescribed for use in children have not been tested in children! In addition, “there are a huge number of drugs that are regularly given to children that have never been tested in children,” said Michael W. Shannon, a professor of pediatrics at Harvard Medical School. “I’m very concerned that many of these agents may also be inappropriate for children.” One factor in the lack of testing in children is the fact that it was considered unethical and unnecessary to test drugs in children. The dosages were extrapolated from dosages for adults.

In 1972, the FDA did organize a panel to review nonprescription cough and cold medicines; previously, their attention had been focused on prescription medicines. This panel concluded that there was enough evidence to endorce 35 of the 92 ingredients. That recommendation was based on studies in adults. In 1976, the group recommended that doses for children be extrapolated from data for adults.

“As researchers began testing some of the products directly in children, they slowly started to raise disturbing questions. The Journal of the American Medical Association published an analysis in 1993 that concluded there was no good evidence that the medications worked. The Cochrane Collaboration, an independent international project that regularly evaluates medical therapies, reached a similar conclusion in 2004.”

The article goes on to say that although many pediatricians began to counsel their patients not to use these products, some continued to tell them that they could use them. The products remained very popular. In 1997, the American Academy of Pediatrics adopted a policy stating that cough medicines are ineffective. The American College of Chest Physicians produced a similar statement in 2006. However, many other organizations have never issued any formal guidance to doctors on this subject.

I have a two year old (almost two and a half) and my doctor has never mentioned any concern. I have to admit that he is rarely sick, but he has had an occasional cough/cold. I had no idea that these products had not been tested on children, that there were concerns that they were ineffective. Giving a child medicine is enough of a struggle; why would I continue to do so, if it is not going to help?

Some experts are defending the doctors’ groups, saying that they are up against a multibillion-dollar industry, a group that aggressively markets their products (spending more than $50 million a year to sell their stuff). I can understand that to a point – it is like going against the tobacco lobby and all the tobacco firms; they have a lot of money to throw at the situation. Still, as a patient, it would have been nice to have been told this. I don’t understand why more doctors don’t say something to their patients.

On the bright side, the FDA has started demanding that some prescription drugs be tested in children before they are approved. It has also enticed drug companies to conduct pediatric studies of some medications already on the market; unfortunately, the article fails to say how they enticed them. The FDA is reviewing recommendations, but it says that formal action could take years. The industry has voluntarily removed products designed for children younger than two from the market, but “maintains that the remedies are both safe and effective for older children when used properly.”

Well, I’m going to keep watching to see what happens. I want to know if the industry will police itself, if the FDA is going to wake up and take action, … I want to know if doctors are going to pass on information like this to their patients in a more organized fashion. I’m also going to do my part and be a more aware consumer.

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Recall of Children’s Cough Medicines

Johnson and Johnson recalled specific infant cough and cold products today, saying that “rare” instances of improper use, particularly in infants under two years old, have lead to overdoses. These products include:

  • Infants’ Tylenol Drops Plus Cold
  • Concentrated Infants’ Tylenol Drops Plus Cold & Cough
  • Pediacare Infant Drops Decongestant
  • Pediacare Infant Drops Decongestant and Cough
  • Pediacare Infant Dropper Decongestant
  • Pediacare Infant Dropper Long-Acting Cough
  • Pediacare Infant Dropper Decongestant and Cough (PE) products

This recall does not include cough and cold products for children two years and older, or products that are single-ingredient pain reliever and fever reducers expressly labeled for infants.

The Washington Post article is here.

This certainly got my attention. I use, or have used, one product on that list. Of course, I used it properly and after my doctor said it was fine. Still…it makes me second-guess myself; should I give my child this medicine? On the other hand, how can you not give a sick child something if you think it will help?

Well, now the FDA’s Nonprescription Drugs Advisory committee will be meeting this month to discuss the use of cough and cold drugs by children. I will be very interested to see what comes out of that meeting.

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The FDA and Cold Medicines for Children – Part II

According to a Washington Post article today, here (for now), federal officials are now recommending that “consult your physician” be dropped from guidelines on boxes of cold/cough medicine for children under two.  These medicines, in many cases, simply should not be given to young children.  “The preliminary recommendation, from Food and Drug Administration safety officials would apply to decongestant use in children under 2 and antihistimines in those younger than 6, according to agency documents released Friday.”

More than 350 pages of documents were released on Friday.  They are part of a broad investigation into whether roughly 800 medicines (yes, 800) are safe and effective in treating children’s colds and coughs.  Many of those medicines are popular and widely used.

“An FDA review of side-effect records filed with the agency between 1969 and September 2006, found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.”  In addition, a Centers for Disease Control and Prevention report also found more than 1500 toddlers and babies wound up in ERs in a two-year period as a result of the medicines.

The Consumer Healthcare Products  Association (represents makers of OTC medicines)  is backing the recommendation that these products not be given to young children and in terms of antihistamines, they recommend that a warning be added that the medicines not be used to sedate children.

How sad is it that you have to add a warning about that?  And really, do they think that the types of people that would use it for that purpose would care whether there is a warning on the box or not?  It seems to me that the only purpose for that warning is for legal purposes for themselves.  I admit that I’ve wondered about how effective these medicines have been on my two-year-old, but he’s rarely (thank goodness) sick so it hasn’t come up much.  He has taken an antihistimine occasionally, on the recommendation of his doctor, so I wonder about that part of the article as well.  I’m going to have to talk to his doctor about this next time I go in (or rather, next time WE go in).

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