12 October 2007

"Risk vs. Benefit"

Analyzing the crucial balance between risk and benefit remains one of the most challenging tasks of any practicing physician. This is most evident when prescribing medicines and when choosing therapeutic procedures. Since the "perfect medication," or the "perfect procedure" does not exist yet, a physician spends gruelling moments of thinking (which most of the time must be done pronto!) what to give and what NOT to give his patients.

U.S. Food and Drug Administration reviewers have said that from 1969 through 2006 the agency received 54 reports of deaths with decongestants and 69 with antihistamines. Most were in children younger than 2. Overdose and drug toxicity were commonly reported in those cases, they said.

FDA reviewers have recommended that over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not recommended for very young children.

"There are no good studies that provide any information about appropriate dosing if they did work," said Dr. Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine and a signer of the petition.

Medicines that are being recalled from the U.S. market include: Concentrated Infants' TYLENOL Drops Plus Cold; Concentrated Infants' TYLENOL Drops Plus Cold & Cough; PEDIACARE Infant Drops Decongestant (PSE); PEDIACARE Infant Drops Decongestant & Cough (PSE); PEDIACARE Infant Dropper Decongestant (PE); PEDIACARE Infant Dropper Long-Acting Cough; PEDIACARE Infant Dropper Decongestant & Cough (PE) products; Dimetapp Decongestant Plus Cough Infant Drops; Dimetapp Decongestant Infant Drops; Little Colds Decongestant Plus Cough; Little Colds Multi-Symptom Cold Formula; Robitussin Infant Cough DM Drops; Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

[Reuters, 11 Oct 2007]

I wonder when our own BFAD will do its own recall. Our BFAD usually takes its cue from the US FDA's actions.

In the same news item above, Dr. S. Czinn said that it is "unacceptable to be marketing medication to infants and children that may not work." Or worse, harm or kill them, right? Ah, but that is sheer idealism. Idealism has no place in the hearts of businessmen concerned only with earning profits and more profits.

Okay, okay, I'll stop being a cynic now and begin hoping that the same recall happens here soon. Although, I really, really doubt it will happen.

3 reactions:

Anonymous said...

I have 2 young children (one infant), and like millions and millions of Americans, I have been giving them Pediacare (pseduophedrine) for years now on the few occasions every year that they catch a cold that makes their sinuses so congested that they have trouble breathing during sleep. I know it works from experience. I know it works because pseudophedrine works for me too when I am stuffed up with nasal congestion.

Now, they say about 50 children die every year, so now 50 million parents cannot give this useful medication to their children? In doing a cost/benefit analysis, one should factor in the intelligence and intentions of the parents/caregivers who manage to kill their children with pseudophedrine. Unfortunately, America has a society were most people cannot even locate Mexico on a map, and 50,000 people a year die in car accidents on our highways. It is common knowledge that ignorant, poor, and/or selfish parents will give their young children medicines that contain alcohol and other sedatives to make their children sleep. Furthermore, some irresponsible parents will give their children a shot of rum or whiskey to put them asleep.

Now, knowing all of the above, I am inclined to assume those 50 kids who die from decongestant overdose are being overdosed by ignorant, neglient, or grossly irresponsible parents/caregivers.

This ban is ridiculous, and only punishes the vast majority of responsible people for the criminal negligence of a few people.

Anonymous said...

This is an absolutely rediculous ban. I've been using these products with our children since their first cold just 1 year in.

From these statistics, they should take away all playgrounds, cars, boats, swimming pools.

Absolutely rediculous...

These products DO work at the dosages listed, and have provided my children much relief from their suffering (just as their adult version does with us).

What it is going to cause now is parents formulating their own. And you thought there was trouble before!

Anonymous said...

I'm going to stock up while I still can. They are punishing all our children for the acts a few stupid parents. Maybe if they gave proper dosing advise for under two they wouldn't have to guess in the first place!

I do think that you should be careful with the medicine though (although a ban is outrageous!) Constant administration of decongestants can push the congestion in to the chest, it should only be given when a child cant sleep or is EXTREMELY uncofmortable and not regularly like you give tylenol.