Personal Injury Law

Who you going to trust? The FDA or the consumer?

By Edward Bills

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.

The letter, obtained this week by Reuters, comes amid closer scrutiny of dozens of other Tylenol products for children recalled last Friday after FDA inspection turned up contaminated ingredients and unsanitary conditions.

While the agency’s letter does not raise any safety question with such acetaminophen nighttime drugs, it does call into question data backing up their effectiveness.

It is not immediately clear what impact the agency’s decision could have on the combination products, for which the industry initially sought FDA backing in 1995.
Such nonprescription products are not big moneymakers for the drugmakers, but carry significant brand recognition and are widely used.
While they have been sold on the U.S. market for years, winning the FDA’s formal backing offers companies stronger ground with which to market their products.

Tylenol PM is the top-selling nighttime painkiller, ahead of Excedrin PM and Pfizer’s Advil PM, which combines the same sleep aid with ibuprofen.

Still, the FDA’s 15-year gap comes somewhat as a surprise even at an agency where actions can take years.

Full post as published by Bodily Injury Blog on May 06, 2010 (boomark / email).