Acetaminophen, sold under the brand name of Tylenol, is widely regarded as the safest pain reliever available, yet the drug accounts for 100,000 calls to poison control centers, 56,000 emergency room visits, 26,000 hospitalizations, and 450 deaths annually. Many of these injuries and deaths are the result of unintentional overdosing associated with the fact that acetaminophen is contained in many combination over-the-counter products.
The FDA recently failed to take the most obvious steps to reduce these deaths and injuries by restricting the amount of tablets per bottle, or replacing the bottle of loose pills with individually wrapped pills in what are called "blister packs." The United Kingdom made these changes four years ago--long enough to show that such simple measures can reduce the number of people injured by unintentional overdoses of acetaminophen. The most common serious injury is liver damage, which can lead to the need for liver transplant.
The reforms instituted in the U.K. also caused a massive drop in annual sales of products containing acetaminophen--from 123 billion to 84 billion. This is the most obvious reason why similar measures failed to be instituted by the FDA. The financial interest of Johnson & Johnson, McNeil, the company that makes most of the acetaminophen products sold in the U.S., trumped the public's safety, according to a recent report in the BMJ (British Medical Journal). Its author, Ray Moynihan, a Washington-DC-based reporter, obtained a "confidential draft document," which revealed that the staff at the FDA wanted the agency to discuss such reforms as decreasing the "maximum strength" tablets and reformulating combination products without acetaminophen, and standardizing pediatric products.
Such proposals always start with the appropriate FDA advisory committee whose members are primarily outside experts. But Moynihan found that the advisory committee never learned of the recommendations. What's more, an FDA insider told him that the suggested reforms were dropped "because senior FDA managers saw them as too offensive to Johnson & Johnson." The advisory committee decided to make no changes in how acetaminophen is sold or packaged, instead choosing only to expand the product's safety warnings. Drug company executives were quoted as "delighted" and "pleased" with the watered-down recommendations.
COPYRIGHT 2002 Center for Medical Consumers, Inc.
COPYRIGHT 2002 Gale Group