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Tylenol PM, Excedrin PM – FDA States the Data Is Insufficient To Support the Drug Combinations Relieve Sleeplessness

Posted May 06 2010 12:07am

This has been the week for Johnson and Johnson, first the recalls and now the FDA questioning the combination of drugs offering relief and helping people fall image asleep with getting pain relief from the acetaminophen.  This is not the first inquiry with consumer products as last year the FDA called Cheerios a “drug” due to their advertising and Bayer was sued over claiming it helped prevent prostate cancer.   Novartis is also in on this question with Excedrin PM. 

One comment of my own here is that as a blogger I get a lot of emails and information and sometimes I have to really look and evaluate the credibility of some of what I put on the blog to make sure it is credible information and not just marketing material, as I have advertising spots available for those who want that coverage and this way reader know it is advertised too.  BD 

Patients taking the drugs, most commonly sold as Johnson & Johnson's ( JNJ.N ) Tylenol PM and Novartis AG's ( NOVN.VX ) ( NOVN.VX ) ( NVS.N ) Excedrin PM, did not fall asleep significantly faster than those who took only acetaminophen or the sedative, known as diphenhydramine citrate, the FDA said in a letter to the industry earlier this year.

"There is an insufficient basis to support the combination of acetaminophen and diphenhydramine as a nighttime sleep aid for relief of occasional sleeplessness when associated with minor aches and pains," Dr. Charles Ganley, head of the FDA's Office of Nonprescription Products, wrote in a February 16 letter to the Consumer Healthcare Products Association, or CHPA, which represents makers of nonprescription medicines.

In March, J&J's McNeil Consumer Healthcare unit, which makes Tylenol PM, submitted additional data that it said showed the combination has "significantly more benefit for the relief of pain and sleeplessness than either ingredient alone."

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