FDA: Tylenol PM Doesn't Work
Thursday, May 6, 2010 8:04 AM
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Tylenol PM and other widely used acetaminophen pain drugs that include a sleep aid, failed to show any significant benefit in a key study, U.S. health regulators have told drugmakers 15 years after industry submitted the data.
Patients taking the drugs, most commonly sold as Johnson & Johnson's Tylenol PM and Novartis AG's 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 Feb. 16 letter to the Consumer Health Products Association, or CHPA, which represents makers of nonprescription medicines.
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