You know all those drug ads on TV, where new drugs for everything from erectile dysfunction to depression, to cholesterol are touted complete with a shopping list of side effects against a backdrop of shiny, happy people dancing in slow motion in the green grass of a city park, or cavorting across an idyllic beachfront? Case in point, Cialis ad at left.
All that damning voiceover information on side effects and adverse reactions can get lost in the visuals (which is probably the plan), but at least the requisite information is there.
Why did that not happen with Tylenol, and the potential for acetaminophen toxicity?
Why did that not happen with denture adhesive, and the potential for zinc poisoning?
Most realize that most drugs have side effects. Fewer realize that all drugs have side effects at all. And the more intense the drug, the longer the list of adverse reactions. When a new drug designed to treat, say, the propensity to have to get up to pee several times in the night for aging Americans comes on the market, manufacturers know that in order to advertise the drug where their constituents are—parked on their sofas, watching television—they have to abide by advertising regulations and include the side effects.
You may not recall every adverse reaction rattled off in such TV commercials. You may not remember even one. But you are left with the sense that this is serious stuff, and if you’re at Read the rest of this entry »
Bayer is likely seeing its Tylenol sales drop these past few weeks after the FDA finally took aim at acetaminophen over-the-counter (OTC) products and the media made it headlines.
Many consumers are loyal to certain brands and I’ve taken my fair share of Tylenol over the years, but for me, Tylenol’s had its day in the sun. What’s most disturbing is that the FDA has known since at least 1977 that severe liver damage can occur as a result of acetaminophen overdose. Back then, their advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days, but the FDA never took action.
So now the agency is making up for lost time and warning people that taking a few extra Tylenol pills here and there, thinking OTC meds are safe, could result in acetaminophen toxicity. Isn’t that like shutting the barn door after the horse has bolted? Since 1977!
And the German drug maker (with HQ in New Jersey) may soon take a dive in profits-there’s a new kid on the block touting a safe alternative to acetaminophen.
BioElectronics Corp. recently completed an acetaminophen comparison study and its results will be announced next Monday, November 16. Their timing is ripe to introduce ActiPatch and Allay, alternatives to Tylenol and other acetaminophen products.
“We believe this is important research especially considering the many health concerns expressed by the U.S. Food and Drug Administration relative to Tylenol, NSAIDs and other over the counter pain medications,” said Andrew Whelan, CEO of BioElectronics, Corp. ” We look forward to reviewing the full study data and submitting it to FDA in support of our current pending 510(K) applications and additional applications we plan to file in the future.”
In the meantime, no doubt consumers are studying labels on OTC meds more carefully these days, especially after the FDA’s recent announcement about the dangers of acetaminophen overdose in children’s meds. The FDA committee has insisted that all children’s and infant’s acetaminophen products be sold at the same concentration, simplifying dosing instructions. Currently the labels are confusing– there are several different strengths of liquids, chewables, and “Junior” tablets that give dosage instructions by weight and age.
What I find mind-boggling is how Bayer has controlled OTC pain meds for so long while there are safer alternatives.
If you’re like me, you’ve already started to stockpile the usual meds for cold and flu and fever season. With kids back to school, back to daycare, and with all the frenzy over potential flu outbreaks, it’s almost a necessity. But check your medicine cabinets for this one: Johnson & Johnson’s McNeil division has voluntarily recalled 57 lots of infants’ and children’s liquid Tylenol products because of possible bacterial contamination.
According to J&J, an inactive ingredient didn’t meet internal testing requirements and B. cepacia bacteria were detected in a portion of raw material that went unused in the finished product. J&J went on to say that no bacteria were found in the finished product, and that the likelihood of a serious medical event is remote. However, in consultation with the FDA, the company decided to recall the products.
If you have questions, call the consumer call center at 1-800-962-5357.
(source: Tylenol.com) Read the rest of this entry »
Interesting how my local Rite-Aid has magnifying glasses on display in the “Analgesics” aisle—the one where you find acetaminophen. It’s either a brilliant marketing ploy or the result of some merchandiser’s sense of humor. Why? If you’re trying to actually read the medication ingredient lists—the ones in mice type—you can’t, so that magnifier can come in mighty handy.
Now add on the state of mind you’re typically in when you’re tooling down the drugstore aisle in search of acetaminophen. Your eyes are most likely darting across those shelves in search of a red box with maybe some white lettering on a slant (Tylenol). Maybe also a big “E” on a green box (Excedrin). If it’s a bad sinus day, let’s throw in a flash of hot pink (Benadryl). And before you know it there’s an acetaminophen party going on in your little shopping basket.
It’s a no-brainer to monitor acetaminophen doses when Nurse Betty hands you 2 Tylenol tablets in a Dixie cup during a hospital stay, right? Sure, you want more—or an I.V. drip, and it’s a prayer in you-know-what you’ll get it. But Nurse Betty isn’t with you in the Rite-Aid, is she?
And that’s where the trouble can start. Read the rest of this entry »
I’m feeling a bit like news anchor Howard Beale in the movie Network—when he’s mad as you-know-what and not going to take it anymore. Yesterday’s report on the FDA panel that voted to eliminate Vicodin and Percocet is one thing—they’re controlled substances and many times when you’re given or prescribed them you’re in no condition to care about potential risks. You just want a glass of water and pill-in-hand, thank you. So I’ve got no issue with big brother keeping a watchful eye here if risks are outweighing benefits.
But, when the FDA panel starts going off on OTC acetaminophen to the extent where it is recommending dosage limits (i.e., reducing the amount of active ingredient per pill) and suggesting that the current OTC dose—1,000 mg (2 pills at 500 mg each)—be available only by prescription, it’s time to raise an eyebrow.
Here’s the thing. As msnbc.com reported the FDA panel vote yesterday it said, “The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen.”
Keyword: OVERDOSES. Read the rest of this entry »