Last week's voluntary withdrawal of several over-the-counter infant cold medicines, including widely marketed brands such as Tylenol, PediaCare and Triaminic, raises some troubling questions.
The recall was announced by the Consumer Healthcare Products Association, an industry trade group, which previously recommended that the Food and Drug Administration change dosing instructions for children younger than 2 on over-the-counter cough and cold medicine labels from "ask a doctor" to "do not use."
Drug makers are doing their best to spin the story. In announcing the news, they emphasized that the medicines were withdrawn because of potential misuse, not product safety, and said the change does not affect cold remedies for kids 2 and older.
What they didn't say, however, is that both of those claims are being debated.
In response to a petition filed by the Baltimore City Health Department commissioner and signed by 14 physicians, two FDA advisory committees were scheduled to discuss these issues Thursday and Friday. The petition argues that over-the-counter cough and cold medicines are neither safe nor effective for children younger than 6 and urges the FDA to educate the public and require manufacturers to include this disclaimer on product labels.
"Your child's safety is our number one priority," promises McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that makes Tylenol and PediaCare, in large letters at the top of a statement about the recall on its website.
Yet, if that were really true, the labels on medicines marketed to young children would have left nothing open to interpretation. Instructing parents to "ask a doctor" before giving a cold remedy to a child younger than 2 creates the expectation that doctors have access to evidence-based dosing information and implies that the medicine can safely be given to such children under a doctor's supervision.
However, according to the American Academy of Pediatrics, multiple studies show that these medicines simply do not work in children younger than 2 and should not be used.
So, if the American Academy of Pediatrics believes these medicines don't work and may not be safe, why have they been on the market for so long? Why isn't marketing of drugs better regulated, and who is looking out for the littlest consumers in our over-medicated culture?
In a perfect world, all parents would be cautious about medicating children, diligent in reading the fine print and conscientious about following dosing instructions carefully. They would always consult a doctor when in doubt about whether a medication was appropriate. And they would never, ever make a mistake.
Obviously, things are different in the real world. Mistakes happen _ especially in the middle of the night when a sick toddler is crying and a sleep-deprived parent is desperately rummaging through the medicine cabinet, searching for something that might make the child feel better.
In our quick-fix society, does it really come as a surprise that parents are unintentionally misusing these drugs?
Relentless marketing by the pharmaceutical companies has created the illusion that there is a pill for every problem. Parents are bombarded with advertising for children's cold remedies: magazine ads, coupons, free samples, and who hasn't seen those cute kids in the TV commercials, with their nighttime sniffles _ and happy faces the morning after their (medication-induced) good night's sleep?
Can you really blame a parent for thinking that, somewhere in the dizzying array of pediatric cold medicines at the local drug store, there's a magic elixir for their child?
Each time a widely marketed drug is recalled, I find myself wondering: What if the pharmaceutical companies are intentionally using an unsuspecting public as guinea pigs for their drugs?
Or are they just in such a hurry to make money that they rush new drugs to the market without adequate testing? Which would be worse?
Conspiracy theories aside, it's clear that each drug recall, voluntary or otherwise, makes it more difficult to trust these folks with our health, let alone the health of our children. Let's hope the FDA will do its job and thoroughly investigate this issue.
If the claims put forth in the Baltimore City Health Department's petition are substantiated, many more children's cold medicines could disappear from store shelves _ leaving the pharmaceutical companies with no choice but to go into the chicken soup business.
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Lisa Miller is a freelance writer who lives in Oneonta. She can be reached at lisamiller44@hotmail.com.
