Linda Suydam, president of the Consumer Healthcare Products Association, said in a statement Tuesday that many of the trade association's member companies had also already implemented label improvements.
"As FDA states in this proposed rule, consumers should remain confident that over-the-counter analgesics continue to be safe and effective," Suydam said. "The reality is, however, that over-the-counter medicines are real medicines with real risks if misused."
Not everyone agrees that the over-the-counter painkillers targeted by the regulations are safe.
"Acetaminophen is a very dangerous drug," said Dr. John Brems, professor of surgery and chief of intra-abdominal transplantation at Loyola University in Chicago.
Brems says he admits at least a dozen patients every year suffering liver failure caused by the drug.
"Many of these patients took acetaminophen in addition to alcohol," he said. "I end up transplanting three to four patients per year, and two to three die before we can transplant them. It is probably the most dangerous OTC drug in this country."
Some suggest that acetaminophen's over-the-counter availability indicates a lack of awareness of its danger.
"[Acetaminophen] is a leading cause of death from pharmaceuticals," said Dr. Edward Boyer, chief of the division of medical toxicology at the University of Massachusetts. "The fact that it is an OTC medication suggests to the uninformed a lack of danger associated with its use."
Many patients assume that painkillers like acetaminophen are completely safe because they are available not only through doctors, but also through pharmacies, grocery stores, and even gas stations.
"Consumers usually have no idea of the toxicity of OTC drugs," said Dr. Walter Peterson, professor emeritus of medicine at the University of Texas Southwestern Medical Center at Dallas. "They believe that because they are OTC, they are safe."
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