Acetaminophen Linked to Asthma
March 10, 2010
Natural News
By David Gutierrez
The common painkiller acetaminophen may increase the risk of asthma and other allergies in both children and adults, according to a study conducted by researchers from the University of British Columbia-Vancouver and published in the journal CHEST.
Acetaminophen, also known as paracetamol, is the active ingredient in the painkillers Tylenol, Anacin, Panadol, and others. Because it does not increase the risk of gastrointestinal bleeding the way aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) do, it has become the favored analgesic and fever-reducer used in young children.
Researchers reviewed 19 prior studies on a total of 425,000 children and adults. They found that children who had been treated with the drug in the past year were 60 percent more likely to suffer from asthma than children who had not, while adults who had used the drug in the past year were 75 percent more likely to suffer from the condition. People who had taken higher doses of the drug had a higher risk of asthma than people who had taken lower doses. The data also showed a connection between acetaminophen use and wheezing, eczema, runny nose and itchy eyes.
The study was not designed to prove cause and effect, however.
Researchers have been looking for causes of the significant increase in asthma rates over the past 20 years. Suggested culprits have included air pollutants and overly sterile living environments, but the current study points to another potential contributor.
According to co-author Mark FitzGerald, it was roughly 20 years ago that doctors began to recommend acetaminophen rather than aspirin for the treatment of fevers and pain in children.
“There was a change in practice and in the succeeding 20 years or so the prevalence of asthma has increased also,” he said.
Although ibuprofen does not appear to increase the risk of asthma, it may cause liver and brain damage in some children.
“For adults, ibuprofen is probably the safer of the two in terms of asthma risk,” co-author Mahyar Etminan said. “For kids, pediatric guidelines still point to acetaminophen use — at least until we have a more definitive study.”
Click here for the full report.
Your Asthma Could be Caused by Acetaminophen
November 24, 2009
NaturalNews
by S. L. Baker
Acetaminophen, the pain reliever and fever reducer found in Tylenol and many other over-the-counter as well as prescription drugs (such as Lortab), is often hyped for its supposed safety — specifically because it doesn’t cause stomach upset as often as aspirin. However, in recent years, it has become clear that acetaminophen can cause liver damage and, when combined with alcohol, stomach bleeding. Now comes another warning: researchers have linked the drug’s use to an increase in asthma and wheezing in both children and adults.
According to the National Institute of Allergy and Infectious Diseases (NIAID), asthma affects 16 million adults and nearly 7 million children in the US. It is, in fact, the most common serious chronic disease of childhood. A respiratory disease of the lungs, it is marked by episodes of inflammation and narrowing of the lower airways in response to asthma triggers which include infectious agents, stress, cigarette smoke, air pollution, dust mites and pollen. A new study just published in the November issue of Chest, the peer-reviewed journal of the American College of Chest Physicians, suggests acetaminophen can also be an important asthma trigger.
Canadian researchers at the University of British Columbia in Vancouver, British Columbia, conducted a detailed analysis of 19 clinical studies which contained information linking asthma and/or wheezing to taking acetaminophen. In all, a huge number of research subjects — 425,140 — were included in these studies.
The results of the investigation showed the odds of having asthma were significantly raised among people who took the pain reliever. The analysis specifically showed a worrisome risk of asthma in children who had been given acetaminophen in the year prior to their asthma diagnosis or in the first year of life. And the findings raised another red flag concerning the use of acetaminophen by pregnant women. The study results showed an increase in the risk of asthma and wheezing in children if their mothers had taken the drug prenatally.
Writing in Chest, the researchers called for future studies to further confirm their analysis. They concluded: “The results of our review are consistent with an increase in the risk of asthma and wheezing in both children and adults exposed to acetaminophen.”
Asthma May have Link to Acetaminophen
November 06, 2009
Eurekalert
New research shows that the widely used pain reliever acetaminophen may be associated with an increased risk of asthma and wheezing in both children and adults exposed to the drug. Researchers from the University of British Columbia, Vancouver, BC, Canada, conducted a systematic review and metaanalysis of 19 clinical studies (total subjects=425,140) that compared the risk of asthma or wheezing with acetaminophen exposure.
The analysis showed that the pooled odds ratio (odds ratio for all studies combined) for asthma among users of acetaminophen was 1.63. The risk of asthma in children who used acetaminophen in the year prior to asthma diagnosis or in the first year of life was elevated to 1.60 and 1.47, respectively.
Furthermore, results showed a slight increase in the risk of asthma and wheezing with prenatal use of acetaminophen by mothers. Researchers speculate that acetaminophen’s lack of inhibition of cyclooxygenase, the key enzyme involved in the inflammatory response of asthma, may be one explanation for the potential link between acetaminophen use and asthma.
FDA Warns of Fatal Overdose Risk with Propoxyphene, but Leaves Narcotic on Pharmacy Shelves
July 8, 2009 by mike
Filed under Government
July 8, 2009
ABC News
by Crystal Phend
The U.S. Food and Drug Administration has called for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene — but it will not order their withdrawal from the market.
The agency ordered manufacturers to study higher-than-expected fatality rates in propoxyphene overdoses compared with other painkillers — and possible toxic effects on the heart in when consumers exceed recommended doses.
However, the FDA rejected a petition from the consumer group Public Citizen calling for phased withdrawal of these products.
In its action, announced during a press briefing on Tuesday, the agency rejected the advice of its own advisory panel, which voted 14-12 for a ban on propoxyphene products because of overdose risk and doubts about their painkilling effectiveness.
Propoxyphene is an opioid painkiller chemically similar to methadone. Some pain specialists, such as Dr. Lloyd Saberski of the Yale-New Haven Hospital in Connecticut, criticize propoxyphene as a weak narcotic with no place on the shelf.
“There is no legitimate medical advantage to keeping propoxyphene available,” Saberski said. “You are much better off using small amounts of a potent narcotic; there will be little in the way of side effects.”
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, defended propoxyphene as an effective combination treatment option that goes beyond the strength of acetaminophen — commonly known by the brand name Tylenol — alone.
“All current pharmacologic options for pain have significant liability,” she said in a media briefing. “Given the data currently available to FDA, propoxyphene is an acceptable choice for the treatment of mild to moderate pain when it’s taken as directed.”
Today’s announcement comes just a week after an FDA advisory panel recommended a black box warning for prescription products containing acetaminophen. That panel also voted by a narrow margin to recommend that the FDA pull prescription acetaminophen-containing analgesics from the market.
Click here for the full report from ABC News.
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Black Box, Mixed Message? FDA Panel Delivers Acetaminophen Recommendations
July 1, 2009 by mike
Filed under Government
July 1, 2009
ABC News
By Dan Childs & Emily Walker
If a U.S. Food and Drug Administration expert panel has its way, prescription pain killers, like Vicodin and Percocet that contain acetaminophen will be eliminated from the country’s formularies.
Yet, the very same panel voted to keep over-the-counter combination pills containing acetaminophen on the shelves.
Those recommendations are only two of 10 concerning acetaminophen the panel made, including one to lower the maximum dosage of over-the-counter pain medications that contain acetaminophen, like Tylenol.
A joint panel of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee voted on the issues after two days of considering ways to reduce the liver damage risk of acetaminophen, the most commonly used painkiller in the country.
The recommendations are not binding, but the FDA usually adopts them. It’s no clear when the FDA will announce a final decision.
The panel voted 24 to 13 against a proposal to remove over-the-counter combination drugs from the shelves. This would save drugs that combine acetaminophen and other drugs like caffeine like Excederin, and a wide variety of popular cough-and-cold combinations.
About 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental. They often occur when a consumer unknowingly takes more than one acetaminophen product.
Doctors were largely split in their opinions over the votes — and the fault lines appeared to follow their areas of expertise and the kind of patients they treat.
Liver disease experts largely applauded the recommendations. Dr. William Lee, chair of the liver diseases department at the University of Texas Southwestern Medical Center at Dallas, said he was “highly gratified” by the outcome of the votes limiting acetaminophen use.
Click here to read the full ABC News report and to watch the video.
The Kevin Trudeau Show: 06-30-09
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FDA May Put Restrictions on Tylenol
June 29, 2009
The Food and Drug Administration has assembled more than 35 experts to discuss ways to prevent overdose with acetaminophen – the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.
Despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.
The agency today asked its experts to consider a range of options: adding a “black box” warning label to the products, lowering the drug dosage in some products, or pulling certain types of medications off the market.
The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose.
The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug.
But the industry group that represents Johnson & Johnson, Wyeth and other companies defended the products today, saying they pose a relatively small risk to patients.
Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Percocet, which combines oxycodone and acetaminophen.
“We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen,” said Linda Suydam, the group’s president.
The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
Tylenol-maker Johnson & Johnson also pushed back against a proposal to lower the maximum daily dose of acetaminophen, which is currently 4 grams daily, or eight pills of a medication like Extra Strength Tylenol.
While taking more than 4 grams per day can cause liver injury, J&J argued that taking the exact dose is proven to treat osteoarthritis pain.
J&J also warned panelists that any new restrictions on acetaminophen would force patients to switch to nonsteroidal anti-inflammatory drugs, which carry risks of gastrointestinal bleeding and sometimes fatal kidney injury.
“When switching occurs, the risk of death increases,” said Dr. Kenneth Rothman, a consultant for J&J. According to figures from Rothman, a 30 percent switch away from acetaminophen would result in an additional 5,000 deaths per year.
Top-sellers in the anti-inflammatory drug market include Bayer AG’s aspirin and Wyeth’s Advil.
Executives from Wyeth scheduled a series of media briefings last week, arguing there’s no evidence that the reduced use of acetaminophen would cause more negative side effects with their drug.
“There are major flaws in their arguments that are not born out in real world experience,” said Dr. Paul Desjardins, a vice president with Wyeth.
Desjardins pointed out that the U.K. has put tighter safety measures in place for acetaminophen without causing increased problems with Advil and other nonsteroidal anti-inflammatory drugs.
For its part, the FDA has made clear it will not play king-maker in the market for over-the-counter medications. The agency says its only goal is to reduce liver injury, “not to decrease appropriate acetaminophen use or to drive people to use NSAIDS instead.”
Click here to read the full report from the Associated Press.
