It’s the time of year where if you’re not sick, someone you know probably is. The influenza season in the Northern hemisphere started out slowly, but seems to be accelerating and hasn’t peaked yet. Add that to cold viruses circulating, and you get the peak purchasing period for cough and cold remedies. John Snyder gave a nice summary of the evidence base for the common treatments a few weeks ago. In short, despite all the advertising, there is little evidence to suggest that most of the “tried and true” products we’ve used for decades have any effect on our symptoms. One of the most sensible developments that’s occurred over the past few years has been the discontinuation or relabeling (depending on your country) of cough and cold products for children. The rationale to pull these products is compelling: Cough and cold remedies have a long history of use, and were sold without prescriptions before current regulatory standards were in place. They were effectively grandfathered onto the marketplace. When it comes to their use in children, the data are even more limited. There are few published trials and the results are complicated by different age groups, irregular dosing, lack of placebo control, and very small patient numbers. What’s even harder to believe was that doses were based mainly on expert opinion, not data, and generally didn’t consider that children don’t handle drugs the way adults do. So why withdraw them from pediatric use, but not adult use? Like most regulation, it comes down to risk and benefit. Both are troubling for pediatric use. (more…)
We spend a lot time at SBM discussing different elements of the art and science of medicine, and how we believe that practice can be improve. Yet our science-based intentions can be thwarted at the last possible moment – in the form of dosing errors. The workup may have been comprehensive, the diagnosis could be correct, the most clinically and cost-effective intervention chosen, and whammo. An overdose or underdose, possible toxicity, and a failure to achieve the desired outcome. It’s a completely avoidable, but often overlooked aspect of the practice of medicine.
In my last post, I noted how cough and cold products for children have largely been withdrawn from the market due to their lack of efficacy, and the risks related to toxicity. Today’s post is going to dive a little more deeply into factors that can contribute to toxicity in the pediatric population. Let’s start with a vignette that may be familiar to parents:
The new father is wakened from a blissful, deep sleep by a crying child. Once Dad realizes when and where he is, and the source of the crying, he silently curses the short duration of action of the acetaminophen liquid he gave his child at bedtime. It has probably worn off already, and the fever is back. Stumbling into his child’s room in the dark, he can feel the heat radiating off his body. He fumbles around for the Tylenol, and something to measure it with. He can’t find the dropper bottle, but finds a bottle of syrup. It’s hard to measure the dose in the dark, and the medicine cup he finds is hard to read. “I think the dose is a teaspoon..that’s 5mL”. He pours the medicine into his child’s throat, tucks him back into bed, and both are back asleep within minutes.
I’ve previously described the consequences of acute and chronic sun exposure, and the rationale for topical sunscreen products. But wouldn’t it be easier to just take a pill that can boost our skin’s resistance to to the harmful effects of the sun? Is it possible to get all the benefits of sunscreen without the bother of creams, or even clothing? (more…)
Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.
Should Drug A be available without a prescription?
Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.
Should Drug B be available without a prescription?