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FDA Says Tylenol PM Has No Benefit

May 5, 2010

Health regulators recently reported that Tylenol PM, and other acetaminophen pain drugs that include a sleep-aid, failed to show any significant benefit.

The FDA reports that patients taking the drugs did not fall asleep significantly faster than those who took only acetaminophen or the sedative, known as diphenhydramine citrate.

Dr. Charles Ganley, head of the FDA’s Office of Nonprescription Products, wrote in a February 16 letter to the Consumer Health Products Association (CHPA), which represents makers of nonprescription medicines, “We know then that the ingredients have been accepted as safe and effective, we know the final labeling, we know the final dosages … there’s much more certainty.”

The FDA has not raised safety concerns over the years despite the agency’s concerns that the initial study does not support the drug.

Tylenol PM is the number one selling nighttime painkiller, followed by Excedrin PM and Pfizer Inc.’s Advil PM.

According to market research firm SymphonyIRI Group, Tylenol PM sold $94.5 million worth of the drug in a year and ranked as the fifth largest-selling analgesic brand tablet.  Excedrin brought in $14.7 million in sales.

The Chicago-based research firm, which tracks most drugstores, supermarkets and mass market retailers, said that Advil PM saw $48.6 million during the same period.

Company spokeswoman Caroline Almedia told Reuters that Johnson & Johnson’s McNeil Consumer Healthcare unit, which is the maker of Tylenol PM, submitted additional data in March after working with the FDA in 2006.  The two J&J studies looked at several hundred people and were completed last year.

“These data indicate that the combination of an analgesic and sleep-aid provides significantly more benefit for the relief of pain and sleeplessness than either ingredient alone,” McNeil wrote in a March 31 letter to the agency.

It was not immediately clear if other makers performed similar studies on their nighttime acetaminophen.  Novatis referred questions to the CHPA, which was not immediately available for comment, according to Reuters.

The FDA said it would consider any new industry data.

Unlike prescription medications, over-the-counter drugs can be marketed without going through a formal approval process as long as their main ingredients are on the FDA’s approved list, which is known as a monograph.

However, if a nonprescription drug does not meet the list’s standards then it must win approval before being sold in the U.S.

The FDA’s 15-year gap comes as somewhat of a surprise even at an agency that can take years before taking action.

Burgess blamed the agency’s “significant workload in regulating over-the-counter drug products” and need to prioritize based on available agency resources.

She then said the letter did not reflect any other initiatives at the FDA, including Friday’s recall or recent concerns over acetaminophen’s risk of liver toxicity.

Reuter’s industry source said that while the FDA’s timing seems startling, Ganley’s answer was not.  Standards have changed since CHPA’s 1995 submission and two studies are now typical.

“This was simply a study that didn’t work. … I don’t think it surprised anyone,” the industry source told Reuters.

Tylenol and Excedrin’s rival, Advil PM, won its FDA backing in 2005.

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