The recent FDA hearing on Tylenol (acetaminophen) use discussed consumer misconceptions of over the counter (OTC) drugs, overdosing and suicide, hepatoxicity and more. The panel made several recommendations about reducing maximum dosages, adding label warnings and removing certain drugs from the market. Members of the NY law firm, Weitz & Luxemberg, attended the meeting. Here is one of their attendee's notes:

Three most pertinent issues addressed

Participants at the recent two day FDA (U.S. Food & Drug Administration) acetaminophen hearing in Washington DC included McNeil Consumer Healthcare, the Johnson & Johnson subsidiary which manufacturers Tylenol, as well as lawyers, consumer advocate groups and private citizens. While several issues were discussed at the hearing, the most pertinent issues seemed to be:

1. a general lack of awareness among consumers and even healthcare professionals about the dangers of taking too much acetaminophen
2. reducing the maximum daily recommended dosage of acetaminophen as a way to avoid hepatoxicity
3. There was discussion about the possibility of adding icons and less ambiguous language to labeling to do a better job of alerting consumers about the presence of acetaminophen in combination products, the maximum safe dose and the possible side effects of ingesting too much acetaminophen.

Public misconception that more is better

Experts addressed the issue of acetaminophen and hepatoxicity as well as the public's general unawareness of its consequences and said that a majority of the public are under the misconception that taking more than the maximum recommended dosage of an over the counter drug can't seriously hurt them.

Acetaminophen overdose & suicide

The issue of acetaminophen and suicide was also discussed at the hearing. Experts said that many people are using Tylenol as a way to commit suicide, but most don't realize that death does not occur immediately after overdosing. In fact, they stated that death may not occur for days afterward. Those that reconsider their actions often don't seek medical attention until it's too late.

How the panel voted

The panel voted:

• 36-1 in recommending that a black box warning be placed on prescription medications that combine acetaminophen with another drug.
• 21 to 16 in recommending that the FDA lower the maximum daily dosage for acetaminophen from the current 4,000 mg to 2,600 mg and lower the single adult dosage from 1,000 mg to 650 mg.
• 24 to 13 in recommending that the 500 mg acetaminophen pill would be available by prescription only.
• 26-11 in recommending changing the 1,000-mg over-the-counter dose to a prescription-only status.
• 20-17 in recommending taking opioid drugs that contain acetaminophen, such as Vicodin and Percocet, off the market.

Time will tell

Although the FDA panel addressed several issues on acetaminophen usage, it will likely take months for the FDA to decide whether or not to implement those recommendations. In the meantime, products liability lawyers say that lawsuits against the manufacturer from patients who have experienced liver injury and its complications (i.e., acute liver failure, hospitalization, liver transplant, hepatic coma, death and medical costs) continue to be filed.