First do no harm. That’s one of the most basic and important concepts in the practice of medicine. But in this day and age, profit seems to have taken that age-old motto’s place …Even when it comes to our children. The Associated Press reported that “Very young children simply should not take some commonly used cold and cough medicine federal health officials say in recommending that the “consult your physician” advice to parents on the labels be dropped. The preliminary recommendation, from Food and Drug Administration safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents.
The more than 350 pages of documents are part of a broad and ongoing FDA examination of whether the roughly 800 medicines, many popular and widely used, are safe and effective in treating children’s colds and coughs.” The FDA review came in response to a petition filed by Baltimore city officials who say many of the over-the-counter cold and cough medicines can harm toddlers and pre-schoolers. According to the Associated Press article: “Those officials, joined by the American Academy of Pediatrics, cite evidence that suggests the drugs are not only risky but also don’t work in the very young.
“The basic question is why a product should be so relentlessly marketed when it’s not safe or effective?” said Dr. Joshua Sharfstein, Baltimore’s health commissioner. “It does not make sense, in the absence of information, to say ‘consult a physician,’ because they do not have superhuman powers. They cannot make a product safe or effective.” Here’s something interesting: The Consumer Healthcare Products Association (which represents the makers of over-the-counter medicines) supports not using these cold and cough medicines in children under the age of two. The association’s president, Linda Suydam, said they recommend adding a warning that the drugs not be used to sedate young children.
Wow. It’s a sad state when labels stating THAT has to be added and is not common sense to most parents. But in many parents’ defense — society has been BOMBARDED with brilliant marketing campaigns that make these drugs sound safe and effective. And even beyond that – flat out miracles. That being said… check out what Dr. William Campbell Douglass II, M.D. has to say about the issue: “I grumble about the incompetence of today’s parents a lot. It’s no secret that I think new-fangled ‘diseases’ such as ADD and ADHD are nothing more than kids being kids — and parents NOT being parents. I shudder to think that the future of this great nation is going to be largely in the hands of children who were diagnosed with a psychiatric disorder and have been dependent on drugs nearly from infancy.
“Something I haven’t spilled much ink over — but that is equally deserving of ridicule, in my eyes — is the absurd action of sedating children with OTC cold and allergy drugs. It’s a whole new level of irresponsibility and selfishness on the part of parents, caregivers, and anyone else who thinks children should come with an on/off switch. Newsflash: It doesn’t work that way. “Still, that hasn’t stopped a portion of the population from drugging (yes, drugging — let’s call a spade a spade) children with allergy or cold medicines whenever it was convenient. But if the ethical concerns weren’t strong enough to make these people think twice, maybe the safety concerns will.
“The sedation issue has brought about the long overdue examination of certain cough and cold medicines for children THAT WERE NEVER ADEQUATELY TESTED in children. It’s a dirty little secret, but now pediatricians and health officials are finally bringing it to light. “Brand names that have become the standard treatment for children — drugs such as Toddler’s Dimetapp, Triaminic Infant, and Little Colds — were placed on the market before the FDA tightened its pre-market testing standards. The main compound in Benadryl (diphenhydramine) is under inspection for the same reasons.
“This will likely come as a shock to most parents. After all, the drug companies are allowed to market the cough medicines for children — even though no studies have been done showing that they’re safe OR effective!” This newsletter is not endorsing or condemning the statement made by Dr. Douglass. What it does endorse is open discussion on the subject, and Dr. Douglass’ right to his opinion. You must admit – it is something to think about. Especially when you take these facts into account: An FDA review of side-effect records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.
Most of the deaths were children younger than 2. The CDC found that in 2004 and 2005, over 1,500 children less than 2 years old had to be taken to the hospital after taking a common cough and cold medicine. Three of them died. And in Maryland alone (where the petition to review the safety and efficacy of cough and cold medicines originated), 900 children under 4 years old overdosed on these medications in 2004, and in the last 5 years such drugs have been linked to 4 deaths. Also on September 28th, the FDA gave drug companies until Oct. 31 to stop making and selling any unapproved prescription medicines labeled for use by children younger than 6 that contain the painkiller and cough suppressant hydrocodone.
The move is part of a broader effort to remove from sale an estimated 200 unapproved prescription cough medicines made with the narcotic. Manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008, the FDA said. It said the order applies to most of the hydrocodone formulations sold as cough medicines. And according to Dr. Douglass, “Manufacturers claim that the drugs are safe when they’re used on the proper age group (6 years old and up) and with the proper dosage.” But do they even know what constitutes proper dosage? According to Dr. Charles Gangley, the Director of the FDA’s Office of Nonprescription Drug Products, most dosages listed on these labels are no more than EDUCATED GUESSES. He said, “We have no data on these agents of what’s a safe and effective dose in children.” My advice: We’re talking about children here, infants and toddlers. So first things first: Let’s worry about SAFETY first and get to effective from there.”
