Posts Tagged ‘ tylenol ’

Has Tylenol had its Day in the Sun?

November 12th, 2009. By janem

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.

tyle Has Tylenol had its Day in the Sun?

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.


Mom Alert - Infant & Children Tylenol Recall

September 25th, 2009. By AbiK

If you’re like mSome lots of Infant's and Children's Tylenol have been recallede, 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.

Here’s the full list for the Tylenol Recall:

(source: Tylenol.com)

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Acetaminophen Hide and Seek

July 13th, 2009. By AbiK

magnifyingglasses Acetaminophen Hide and SeekInteresting 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.

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Acetaminophen: Whatever Happened to Personal Responsibility?

July 1st, 2009. By AbiK

networkhowardbeale Acetaminophen: Whatever Happened to Personal Responsibility?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.

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