Dulane
12-20-2006, 01:07 PM
By ANDREW BRIDGES, Associated Press Writer
Wed Dec 20, 3:13 AM ET
WASHINGTON - Popular over-the-counter pain pills such as aspirin, ibuprofen and acetominophen would have to carry labels with sterner warnings under a government proposal to better emphasize the drugs' risks.
Federal health officials on Tuesday cautioned the tens of millions of Americans who take the drugs of their potentially serious side effects and released the planned label changes.
Aspirin, ibuprofen, acetaminophen and the other related over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said.
However, overdoses of acetaminophen can cause serious liver damage, even death, the FDA said.
For aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and kidney injury even when patients take the correct dose. Those risks, too, are linked to thousands of deaths each year. The FDA cautioned the risk is low when compared to the number of patients who take the drugs.
Experts called the stepped-up warnings long overdue, since federal advisers called for similar label changes in 2002. An FDA official chalked it up to the time required to write new regulations.
"That is one of the disadvantages of the rule-making process," said Dr. Charles Ganley, director of the FDA office that oversees nonprescription products.
The drugs are found in hundreds of medicines sold to treat pain, headache and fever. Health officials worry that the wide availability of those combination products can lead to patients unintentionally overdosing. Doctors report cases of patients taking two or more medicines — say, one for pain and another for flu symptoms — without knowing they both contain acetaminophen.
The FDA already updated the warning labels on the drugs in the past. In 2002, FDA advisers recommended further changes. In 2004, some of the warnings contained in the new proposal were included in pharmacy brochures and public service ads — a move that some critics said didn't go far enough.
The latest proposed changes largely would strengthen and highlight those warning labels. They also would require the more prominent disclosure, using fluorescent or bold-faced type, of the presence of the drugs among a medication's ingredients.
"It's a step that's overdue and really reflects the consensus that came out of the meeting four years ago, which is helping the consumer know what they are taking," said Dr. Paul Watkins, a professor of medicine at The University of North Carolina at Chapel Hill and a member of the 2002 advisory panel.
For acetaminophen, the labels also would warn of the risk of severe liver damage if patients take more than the recommended dose or consume three or more alcoholic drinks a day while on the drugs. The labels also would warn patients not to take multiple medicines that contain acetaminophen. In any given week, an estimated 48 million Americans take an acetaminophen product.
For aspirin, ibuprofen, naproxen and other nonsteroidal anti-inflammatory drugs, or NSAIDs, their labels would have to contain additional warnings of the risk of stomach bleeding. The labels would note the risk is higher in patients older than 59, or in those who have stomach ulcers, take blood-thinning drugs or steroids, use other drugs that contain an NSAID or remain on the medications for an extended period. An estimated 17 million Americans take an NSAID daily.
Acetaminophen is sold under the brand name Tylenol and in multiple generic versions. Acetaminophen sends an estimated 56,000 people to the emergency room each year, the FDA said. About 100 people die each year after unintentionally overdosing on the drug.
Ibuprofen is sold under the brand names Advil and Motrin and in generic form as well. Naproxen is best known as Aleve, but is also sold generically. The NSAIDs are blamed for sending more than 200,000 Americans to the hospital every year, and are linked to an estimated 16,000 deaths, the FDA said. The agency said it would address the cardiovascular risks of nonprescription NSAIDs in the future.
The proposal appeared Tuesday on the FDA's Web site ahead of its expected Dec. 26 publication in the Federal Register. Since it could take a year or more for the rule to become final, the FDA said it strongly encouraged companies to update their labels in the meantime, as some companies already have done.
Wed Dec 20, 3:13 AM ET
WASHINGTON - Popular over-the-counter pain pills such as aspirin, ibuprofen and acetominophen would have to carry labels with sterner warnings under a government proposal to better emphasize the drugs' risks.
Federal health officials on Tuesday cautioned the tens of millions of Americans who take the drugs of their potentially serious side effects and released the planned label changes.
Aspirin, ibuprofen, acetaminophen and the other related over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said.
However, overdoses of acetaminophen can cause serious liver damage, even death, the FDA said.
For aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and kidney injury even when patients take the correct dose. Those risks, too, are linked to thousands of deaths each year. The FDA cautioned the risk is low when compared to the number of patients who take the drugs.
Experts called the stepped-up warnings long overdue, since federal advisers called for similar label changes in 2002. An FDA official chalked it up to the time required to write new regulations.
"That is one of the disadvantages of the rule-making process," said Dr. Charles Ganley, director of the FDA office that oversees nonprescription products.
The drugs are found in hundreds of medicines sold to treat pain, headache and fever. Health officials worry that the wide availability of those combination products can lead to patients unintentionally overdosing. Doctors report cases of patients taking two or more medicines — say, one for pain and another for flu symptoms — without knowing they both contain acetaminophen.
The FDA already updated the warning labels on the drugs in the past. In 2002, FDA advisers recommended further changes. In 2004, some of the warnings contained in the new proposal were included in pharmacy brochures and public service ads — a move that some critics said didn't go far enough.
The latest proposed changes largely would strengthen and highlight those warning labels. They also would require the more prominent disclosure, using fluorescent or bold-faced type, of the presence of the drugs among a medication's ingredients.
"It's a step that's overdue and really reflects the consensus that came out of the meeting four years ago, which is helping the consumer know what they are taking," said Dr. Paul Watkins, a professor of medicine at The University of North Carolina at Chapel Hill and a member of the 2002 advisory panel.
For acetaminophen, the labels also would warn of the risk of severe liver damage if patients take more than the recommended dose or consume three or more alcoholic drinks a day while on the drugs. The labels also would warn patients not to take multiple medicines that contain acetaminophen. In any given week, an estimated 48 million Americans take an acetaminophen product.
For aspirin, ibuprofen, naproxen and other nonsteroidal anti-inflammatory drugs, or NSAIDs, their labels would have to contain additional warnings of the risk of stomach bleeding. The labels would note the risk is higher in patients older than 59, or in those who have stomach ulcers, take blood-thinning drugs or steroids, use other drugs that contain an NSAID or remain on the medications for an extended period. An estimated 17 million Americans take an NSAID daily.
Acetaminophen is sold under the brand name Tylenol and in multiple generic versions. Acetaminophen sends an estimated 56,000 people to the emergency room each year, the FDA said. About 100 people die each year after unintentionally overdosing on the drug.
Ibuprofen is sold under the brand names Advil and Motrin and in generic form as well. Naproxen is best known as Aleve, but is also sold generically. The NSAIDs are blamed for sending more than 200,000 Americans to the hospital every year, and are linked to an estimated 16,000 deaths, the FDA said. The agency said it would address the cardiovascular risks of nonprescription NSAIDs in the future.
The proposal appeared Tuesday on the FDA's Web site ahead of its expected Dec. 26 publication in the Federal Register. Since it could take a year or more for the rule to become final, the FDA said it strongly encouraged companies to update their labels in the meantime, as some companies already have done.