A U.S. Food & Drug Administration (FDA) panel recently conducted a two day meeting on acetaminophen (Tylenol) use. The panel made several recommendations to lower maximum dosages and take some drugs off the market. But should the FDA tamper with how consumers use acetaminophen? Here's what people are saying...

FDA advisory panel recommendations

The FDA advisory panel, which is made up of scientists, doctors and consumer representatives, recommended the following four changes to the way that acetaminophen (link to http://attorneypages.com/hot/toc_762.htm) is used by consumers:

• Lowering daily dosages. Lowering the maximum daily dosage from 4,000 mg to 2,600 mg (21 members voted for in favor of this measure; 6 voted against it.)
• Reducing single dosages. Reducing the maximum single adult daily dose to 650 mg from the current maximum of 1,000 mg, or the equivalent of two tablets of Extra Strength Tylenol (24 members voted in favor of this measure; 13 voted against it.)
• Changing prescription status. Changing the 1,000-mg over-the-counter dose to a prescription-only status (26 members voted in favor of this measure; 11 voted against it.)
• Taking Vicodin & Percocet off the market. Taking drugs that contain acetaminophen, such as Vicodin and Percocet, off the market (20 members voted in favor of this measure; 17 members voted against it.)

Black box warning?

While the FDA itself is free to adopt or ignore the advisory panel's recommendations, it generally adopts them. However, if the FDA doesn't adopt them, the panel has recommended (36-1) that prescription drugs containing acetaminophen should carry a black box warning – the strongest warning available.

What people are saying

Healthcare professional and consumers have differing opinions on whether the FDA should intervene on consumer acetaminophen use. Here's what some people are saying from both sides:

• For FDA intervention:

  Poison control centers. Many poison control centers are glad that the FDA panel has made recommendations to change Tylenol dosages. They say that too many people don't realize how much acetaminophen they're getting and unintentionally end up in these types of facilities. Dr. Tom Caraccio, the Clinical Manager of Long Island's Regional Poison and Drug Information Center at Winthrop University Hospital was recently quoted in Newsday as saying, “I am very happy the FDA is finally looking into this because for many years we've watched this trend going up. We've seen a lot of people getting sick, some needing liver transplants, and some of them dying.”

  Doctors. According to an article in the News & Observer, Dr. Judy Kramer, an Associate Professor of Medicine at Duke University, was quoted as saying, "Many [patients] are legitimate pain patients, not drug abusers. But over a number of years the amount of acetaminophen in any one tablet, either over-the-counter or in prescription drugs, has been creeping up."

• Against FDA intervention:

  Consumers who regularly take Vicodin, Percocet or similar drugs. Here are some of the reactions from people who commented on the News & Observer blog:

  “If you can't read a label, you shouldn't take medicine. These are probably the same people who OD their kids on pediatric Tylenol cold, then want to sue the FDA, and drug makers, and now the rest of us can't buy effective cold medicine for our kids. Very frustrating for people that do have chronic pain … I'm curious, what they will ban next to save us from ourselves?”

  “Another example of the FDA being a friend of the pharmaceuticals and not the people they are paid to protect.”

  “Washington has a Knee Jerk Reaction to all things. I have been taking Tylenol and Aspirin most of my life and had the common sense to use it in moderation. This Reactionary Government wants to think for all people.”

Regardless of whether you are for or against FDA intervention, if you've been injured due to acetaminophen use, contact an experienced products liability lawyer to discuss your situation and evaluate your options. You may be entitled to money damages.