Toddler Deaths From OTC Drugs Linked To Abuse

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cold-medsSome of the 103 children who died after being given the cough and cold may have been deliberately given overdoses to sedate or even kill them, Bloomberg News writes, citing a study in the Annals of Emergency Medicine that examined deaths over the past four decades.

The children who died after taking the drugs ranged in age from 28 days to 10 years, with 75 percent younger than two years old. In 26 cases, the reviewers determined that a child was given the medication with “nontherapeutic intent.” And 10 died in day-care facilities (here is the study).

You may recall an FDA advisory panel recently urged that OTC cough and cold meds should not be given to children younger than 6 years old. Drugmakers voluntarily changed the labels on the medicines to warn against their use in children younger than four years old (back story).

This step won’t protect children whose caregivers administer overdoses to sedate or quiet them, according to Richard Dart, the lead author. “The whole discussion has been portrayed as innocent parents giving their kids medicine and their child is dead,” he tells Bloomberg. “We’re not saying the confused parent who gives an overdose accidentally isn’t important. It is, and we should protect them. But we shouldn’t forget that a significant portion of these cases is not going to be addressed” by the label changes.

Dart began the investigation after he looked into the death several years ago of two children who died after their father, a taxi driver, gave them cold medicine to quiet them so he could sleep. The study listed 10 deaths as suspected homicides, Bloomberg writes. Another 10 deaths in day-care centers may have been due to poorly trained child-care workers using the medication to control behavior. In some cases, children drank the medication out of a glass, instead of a small dropper.

“Presumably these centers are not trying to kill their own clients,” Dart tells Bloomberg. “They’re doing stupid things out of ignorance. These are over-the-counter products and I think people don’t recognize the risks.”

The reports were drawn from poison control agencies, the FDA and drugmakers. The research was supported by funding from McNeil Consumer Healthcare, a unit of Johnson & Johnson that makes OTC cold meds. McNeil was among those that withdrew several products aimed at infants last year.

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  1. Hello! Of course you cannot protect the innocent from the ill intentioned. The only way to do so is to eliminate the ability of caregivers to administer medication. The Baltimore bunch are misguided (albeit probably well intentioned) people who may even have been prompted by FDA staffers to pursue this.

    It’s unfortunate that when statistics are quoted by the agency that people (including media) don’t question the relativity of the statement. If 100 deaths are associated with product X, the time frame is usually over a period of several years however that reality is lost in the sensationalism of the total.

    Thank goodness at least one rational thinker has emerged and delved into the issue.

  2. As an ex-FDA staffer I find Bob’s comments ridiculous about this being prompted by FDA staffers.

    I actually went down to Waxman’s office and met with Scharfstein on much, much more dangerous issues with extremely good documentation. They really weren’t interested. Considering my experience I would think that if they went after this issue of pediatric cough and cold formulae and the major companies rolled over so quick that there has to be something else going on that we don’t know about.

    This is not to dismiss the concern about nefarious activities by caregivers but only to say that my impression is that there is likely another reason that caused the investigation in the first place.

  3. ex-FDAer - Can you share your impression of Sharfstein?

  4. I do not think that my opinion would be useful.

    The meeting was under difficult circumstances and this probably contributed to the outcome.

    Since then I have read and heard other things.

    Thus I don’t believe I can make an informed opinion.

  5. Makes sense; appreciate your thoughtfulness.

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