• by Christine Bittar , December 22, 2006

The Food & Drug Administration wants the makers of over-the-counter painkillers to put stronger warnings on product labels about the potential risks for using the products.

Johnson & Johnson/McNeil's Tylenol stands to come out the biggest loser because its sales got a 10% lift in 2005 when the FDA first pointed safety fingers at ibuprofen-based competitors such as Advil, but did not require any label warnings for Tylenol, whose active ingredient is acetaminophen.

Although it could take up to a year for the new FDA recommendations to become law, the agency recommended that manufacturers begin making the labeling changes now.

J&J said this week it has already made several of the agency's recommended changes to Tylenol labeling.

The new warnings on packaging are due to concerns that consumers are not informed about the potential risks and complications of misusing OTC painkillers. The actual ingredients of concern are acetaminophen (which is the active ingredient in Tylenol and generic versions), and non-steroidal anti-inflammatory drugs, which are commonly known as Nsaids. These include ibuprofen (the active ingredient in Wyeth's Advil and J&J's Motrin) and naproxen, which is in Bayer's Aleve.

The proposed warnings are based on a real--albeit rare--risk of liver failure with acetaminophen and stomach bleeding in the case of Nsaids and common aspirin.

The FDA's proposed warnings stem from complications that can arise from overuse, overdose and/or mixing with other drugs in the same chemical category--a risk that is greater among people over age 60 who are more likely to have arthritis or take these medications regularly. In the case of acetaminophen, the risk of acute liver failure is greater among people who consume three or more alcoholic drinks a day.

Ralph Nader's consumer watchdog group Public Citizen this week questioned why the FDA didn't require this labeling back in 1977, when the FDA Advisory Review Panel first recommended warning consumers that exceeding the acetaminophen dosage could cause liver damage.

Nader's group is also pushing for limiting the number of pills per package of all medications containing acetaminophen in addition to reducing the actual milligrams per pill. This is something that has been done in Great Britain.

More than 200 million Americans a year take Tylenol and other acetaminophen-containing products.