Editorial: Creating a better drug package

Thursday, Dec. 21, 2006 | 7:23 a.m.

I f used improperly, over-the-counter painkillers can cause liver failure, gastrointestinal bleeding and other problems, the warnings for which should be more prominent on drug packaging, Food and Drug Administration officials said earlier this week.

On Tuesday the FDA proposed new rules that call for clearly labeling the containers of painkillers that contain acetaminophen, which can cause liver damage or failure if a consumer takes too many. Products containing aspirin and those containing nonsteroidal anti-inflammatory drugs such as ibuprofen, keptoprofen and naproxen would have to carry warnings about possible gastrointestinal bleeding if used improperly.

Charles Ganley, director of nonprescription drugs at the FDA, said that these drugs are safely ingested by "tens of millions" of people who use them every week. However, doctors have said that serious problems can occur when people take too much of a good thing, such as acetaminophen. The drug causes up to 450 deaths annually from acute liver failure, The New York Times reported Wednesday.

One physician told the Times that some of these overdoses are intentional, as in suicides. But others come from people taking a combination of over-the-counter medications at once - such as a sleeping aid, a cold tablet and something for muscle aches - without realizing that each one contains some acetaminophen. When that happens, it adds up to an unintentional overdose.

Although the FDA is taking action now, it has long known of the risks associated with these over-the-counter remedies. An FDA advisory panel recommended stronger warnings for acetaminophen in 1977 and again in 2002. After the second set of recommendations, some drug companies voluntarily made warnings more prominent, the Times reports, but the FDA did not require them.

It is about time that the agency made these warnings mandatory. When drugs are available without a prescription, there is an assumption that they are mostly safe. But these drugs can cause serious damage if used improperly. The FDA, which evidently has known this for decades, needs to make certain that drug packaging adequately warns consumers of potential dangers.