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- UTAPharm11
- We are pre-nursing students at UTA, currently exploring Pharmacology! The purpose of our blog is to elicit intelligent responses to the question, "Cough and cold medications in children - why is it a big deal?"
6 comments:
Most people would not think that children's cold Medicine was a big deal, but the opinion of the FDA changed in 2006 after a study on over the counter (OTC) children's medication. They found that each year, about 7,000 children ages 11 and younger go to hospital emergency rooms after taking cold and cough medicines, about two-thirds of them ingested without a parent or caregiver nearby, according to a recent CDC study. Children between the ages of 2 and 5 are most often affected. Unfortunately, past studies have also uncovered a number of deaths in very young children who were inadvertently given too much of the medicines.
The FDA committee found that Over-the-counter cold and cough medicines don't work for children under age 6, and giving the common medicine to young children cannot be recommended, a Food and Drug Administration advisory committee said in October 2006. The panel of health experts, which looked at how safe and effective antihistamines, decongestants, antitussins and expectorants are in children, said it is not appropriate to take data from adults and apply it to children under 12.
After a two-day hearing, the panel called for more studies about how the medicines affect children. FDA experts voted 13-9 that certain cold medicines with certain ingredients should not be used by young children. The committee said medicines with the same ingredients could be used by children ages 6 to 12. The experts voted unanimously to require that standardized dosing devices accompany all liquid medicines, in an effort to reduce the likelihood of excessive or unintentional overdosing.
Separately, the committee voted to allow marketing of multiple-symptom products to children between the ages of 2 and 12 if new research showed the products to be safe and effective. Combination products can be particularly susceptible to problems with overdosing because parents sometimes don't realize they are duplicating ingredients. Committee members also emphasized the importance of proper and easy-to-read labels.
The CDC study was general, and didn't have any real depth. It said OTC medicine was linked to the hospital visits, but it never stated it was the main cause for the visit. True, it had also stated that a lot of the overdoses were due to children getting into the medicines without parental supervision. How does this make it the drugs fault? Common sense would know that who to blame there is the parent. As a parent we are told from a childs birth to "child proof" our homes. Does this not include cold medications? My cousin was unsupervised and she got into an adult OTC medication and ate them like candy. Of course she was rushed to the hospital for an overdose, but it had nothing to do with cold medication. Cold medications do have a standardized device that doses the medication for the appropriate age/weight. It is clearly marked on the cup that comes with the medication. They have been supplying them for years, at least 11 I know of cause that is how old my son is and I have always used the dosing method the medicine supplied. The real argument with this topic is who are we going to place blame on? People can claim that OTC cold medications are dangerous and should be banned till the cows come home, though till I see evidence where parental fault is not an issue I am going to continue to be sceptic.
Lot's of kids through history have gotten sick by accidentally getting into cough/cold medication. I agree that a great portion of the responsibility for the child's safety rests with the parents. However, i believe that some standardization in medicines is needed.
Good work. The study sounds fairly well done. As long as there's an awareness, the rest is really up to parental discretion, as it should be.
The responsibility of the parents is, in my opinion, the must crucial factor in this issue. The government can step in and issue some sort of standard for doses that young children should ingest, but it is unecessary. Parents need to be more responsible and safekeep cold medicines whether they are for children or not. As for the other parents who overdoes their children unintentionally, they need to be more responsible as well and think about what they do before they do it. Because some of those parents who do that are probably just trying to silence the crying child.
The ultimate problem this boils down to is the trade off between affordability and safety of drugs. There are so many testing procedures that new drugs have to go through before reaching the ultimate human stage, and even then human studies are the most expensive of all and made as small as possible. There's no way a drug company can afford to do the large-scale epidemiological studies that they need to make sure that medicines are truly, truly safe. Sure you point to their profits but if they really did everything they could to make sure all medicine is 100% risk free Tylenol would probably cost like $1000 bucks per bottle.
Question: when is the last time you read your school newspaper and saw one of those ads that says "Need healthy people age 18-35 for testing of new drug"? Now, when is the last time you saw one that said "Need healthy baby or toddler ages 1-4 for testing of new cold medicine" ? Testing on children is a huge moral no-no in this country. I'm not saying this is a bad thing, I'm just saying I'm not surprised when they don't know that it could have negatively affected children.
Do you want your medicine cheap or do you want it safe?
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