Dimetapp, PediaCare, & Triaminic Gone... Oh My!
Friday, October 12, 2007
Ijeoma Eleazu, PharmD
It's all over the news now...the manufacturers of infant formulations of cough and cold medicines have voluntarily withdrawn them from the shelves. Note, this withdrawal was voluntary, it was not mandated by the FDA. These medications are safe when taken in the recommended doses for the right users, and most people do use them safely and properly for themselves and their children. The manufacturers of these products collectively decided to move forward with this decision in response to some incidences of drug misuse resulting in infants being overdosed (and sometimes in death) and out of "an abundance of caution". Do note that the only medications withdrawn are those targeted for use in infants, not those for children ages 2 and above. Fourteen products are affected by this recall and for a picture list of all them, since the names tend to be too long to remember, click here. For a list of the names of the withdrawn products please see the bottom of this post.
The FDA's Non-prescription Drugs Advisory Committee and Pediatric Advisory Committee will be meeting on October 18th and 19th, 2007 where they will discuss this issue further and come up with some recommendations.
So how should you respond to this? First of all you can be sure that the manufacturers realize the inconvenience this may cause especially since cold and flu season is just around the corner so they are offering refunds on the withdrawn drugs (you do need to take it back to where you got it from though) and some of them are also offering coupons (you'll need to contact the manufacturer directly to receive them). If you choose instead to dispose of any remaining unused portions of these products you may have, do NOT flush it away or pour it down the drain unless specifically instructed to do so. Rather, to be sure children and pets are protected, dilute the medication with water and mix it into either kitty litter or a solid kitchen substance like coffee grinds then place in a sealed bag and dispose of.
Withdrawn products:
- Dimetapp® Decongestant Plus Cough Infant Drops
- Dimetapp® Decongestant Infant Drops
- Little Colds® Decongestant Plus Cough
- Little Colds® Multi-Symptom Cold Formula
- PEDIACARE® Infant Drops Decongestant containing pseudoephedrine)
- PEDIACARE® Infant Drops Decongestant Cough (containing pseudoephedrine)
- PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
- PEDIACARE® Infant Dropper Long-Acting Cough
- PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
- Robitussin® Infant Cough DM Drops
- Triaminic® Infant & Toddler Thin Strips® Decongestant
- Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
- TYLENOL® Concentrated Infants' Drops Plus Cold
- TYLENOL® Concentrated Infants' Drops Plus Cold & Cough
2 Comments:
At Sat Oct 13, 10:31:00 AM 2007,
Anonymous said…
What nonsense. Why would I throw away perfectly good medicine (Pediacare - pseduophedrine) that works to clear nasal and sinus congestion for my 1 year old? This medicine has been recommended by my childrens' doctor for years, and it works on the several occasions every year that my kids get a bad cold and have sinus pain and significant discomfort.
Because some parents over-medicate their infants, we should all be punished?
I am just angry that now I am probably going to have to pay 3 times as much for the same medicine when I have to get a prescription to get pseudophedrine. Either that, or I have to learn to dilute or measure correctly from the toddler version of the medicine when I give it to my 1 year old.
Don't tell me it doesn't work. I have 3 kids, and pseudophedrine (Pediacare) has worked in my family for YEARS now. It has the same active ingredient as Sudofed... you know, that those little red pills that help with sinus pain and nasal congestion in adults.
At Tue Oct 16, 10:28:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Hi Anonymous and thanks for your comment. The medications were not pulled off the shelves because they were deemed to be ineffective or even unsafe for that matter. They are safe and always have been so at the recommended doses, and therein lies the problem. Yes, the few instances where an incorrect dose has been given which resulted in a fatality is really what drove this decision. As stated by the manufacturers of these drugs: "These voluntary actions are being taken out of an abundance of caution"; and really, can they be blamed for giving priority to the health and safety of the general public? It's a tough one for everyone, if more fatalities occur then the drug makers get dinged for not being proactive once they were aware of the potential dangers; on the flip side we all lose access to use of medications with a proven track record of safety and efficacy. I would gladly welcome more comments from others who would like to weigh in on this issue as well.
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