Rolaids Recalled After Complaints of Odor
Janural 19, 2010
The Star
by Lesley Ciarula Taylor
A massive new Johnson & Johnson Inc. recall of over-the-counter medications extended to Canada Friday with consumers urged to stop taking Rolaids antacid tablets immediately.
The Rolaids recall affects bottles of 100 and 150 tablets, said J&J unit McNeil Consumer Healthcare Canada.
“The Canadian company is taking this voluntary action as a precaution following consumer reports of an unusual odour” that is connected to wood pallets used with packaging materials, it said.
Canadian consumers are asked to contact McNeil at 1-800-661-4659, Monday to Friday, 8 a.m. to 8 p.m., for instructions on how to return or replace their antacid tablets, or go to jnj.canada.com
New Brunswick, N.J.-based J&J also broadened its recall in the U.S. Friday to include some batches of Tylenol caplets, geltabs, arthritis treatments, rapid release and extended relief Tylenol, as well as Motrin IB, chewable extra strength Rolaids, Benadryl allergy tablets and St. Joseph aspirin.
Canadians who have purchased the affected medication outside of the country are urged to check McNeil’s product recall list.
Separately, the U.S. Food and Drug Administration sent a warning letter to J&J, saying it waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol may have sickened customers.
Also Friday, the U.S. Department of Justice said J&J paid kickbacks to Omnicare Inc. to push prescriptions for its antipsychotic drug Risperdal.
Tylenol Recalled by Johnson & Johnson
January 16, 2010
By Marley Seaman
Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph’s aspirin because of a moldy smell that has made people sick. It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008. Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration quickly.
The recall includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin.
The FDA and Johnson & Johnson’s McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.
The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.
The smell is caused by small amounts of a chemical associated with the treatment of wooden pallets, Johnson & Johnson said. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.
Click here for the full report
Tylenol For Arthritis Recall Expanded
December 29, 2009
ABC News
Associated Press
Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell associated with nausea and stomach pain.
The New Brunswick, N.J., company says it is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.
Johnson & Johnson had recalled five lots of the product last month.
To date, the side effects, which also include vomiting and diarrhea, have been “temporary and non-serious.”
The health care company says the odor results from the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
Click here for the full report.
Natural Amino Acid Combats Compulsive Behavior
December 22, 2009
Natural News
By David Gutierrez
A supplement of the amino acid N-acetylcysteine may ease the symptoms of compulsive hair pulling, according to a study conducted by researchers from the Minnesota School of Medicine and published in the Archives of General Psychiatry.
Hair-pulling, also known as trichotillomania, is a compulsive disorder that may affect as many as one in seven people at some point. Patients feel a compulsive urge to pull out the hair from their scalps, eyebrows or even eyelashes, sometimes creating bald spots. Some people who suffer from trichotillomania will play with or eat their hair after pulling it out.
Although similar to obsessive-compulsive disorder, trichotillomania is not the same condition and does not respond well to antidepressants or other drugs. The condition is not well understood, but the neurotransmitters dopamine and serotonin are believed to play a role.
Researchers gave a number of trichotillomania patients a 1,200 mg supplement of N-acetylcysteine every day for six weeks. This dose was continued for another six weeks in patients who appeared to be responding, and doubled in patients who did not appear to be responding.
Fifty-six percent of patients treated with N-acetylcysteine demonstrated
“much or very much improved” symptoms, compared with only 16 percent of those treated with a placebo. There were no adverse side effects reported.
The amino acid treatment proved more effective than the success rate of drug treatments, and was on par with the effectiveness of behavioral therapy or a drug-therapy combination.
Researchers said that even if the amino acid treatment proves successful in further studies, behavioral therapy should still be used to try and treat the underlying psychological causes of hair pulling.
Previous studies haves suggested that N-acetylcysteine supplements may also be effective at treating symptoms of bipolar disorder, obsessive-compulsive disorder and schizophrenia. They are also used to treat acetaminophen (Tylenol) overdoses and nasal mucus buildup.
The supplements are available over the counter and by prescription.
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.”
FDA Seeks to Reduce Accidental Overdoses
November 5, 2009 by JP
Filed under Government
November 5, 2009
latimes.com
By Andrew Zajac
Reporting from Washington - In an attempt to reduce the deaths and serious health problems caused by misuse of medication, the Food and Drug Administration is trying to identify the most serious threats and find ways to avoid them.
About 1.5 million preventable “adverse drug events” occur in the United States every year, according to a 2007 study by the Institute of Medicine, part of the National Academy of Sciences. Aside from the toll on health, the errors cost an estimated $4 billion a year, the study found.
“I was frankly stunned at the scope of the problem,” FDA Commissioner Margaret Hamburg said at a news conference Wednesday. The plan, dubbed the Safe Use Initiative, “is something that doesn’t require a new scientific discovery or a budget appropriation.”
The FDA called on doctors, other healthcare professionals and consumers to help identify drugs and circumstances that may be particular problems. The agency will hold public hearings to gather information, said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Among the issues the agency has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage when taken to excess.
The drug is the primary ingredient in Tylenol and is included in several other over-the-counter medications, so it can be difficult for consumers to judge how much they’ve consumed.
The FDA also will scrutinize the information provided to patients, such as package inserts, labels and instructions that pharmacists give when dispensing prescriptions.
Such an examination is long overdue, said Dr. Sidney Wolfe, director of the health research arm of Public Citizen, a nonprofit consumer advocacy group.
“About 99.5% of pamphlets are completely unregulated,” Wolfe said. “They are missing critical information.”
The FDA also recommended ways to reduce dosage errors in liquid medications, such as including a spoon or cup to properly calibrate dosage.
Agency officials acknowledged that they don’t have hard figures about how many people die or suffer serious injury from medication misuse. That’s partly because “preventable harm” covers a range of poorly tracked activities including accidental overdoses, dispensing the wrong medication or the wrong dosage, abuse of medication and drug-quality defects.
Medication errors do not include common side effects, such as nausea associated with some anti-cancer medications.
“Everybody is measuring something at a different level,” said Shawn Becker, director of healthcare quality standards for the U.S. Pharmacopeia, a nonprofit organization that sets standards for strength, quality and purity of drugs. “People have been looking at safe medication use issues for a long time. It certainly is a problem.”
Click here for the full report.
Tylenol Recalls Some Children’s Medications
September 24, 2009
MSNBC
Liquid products pulled for possible contamination of inactive ingredient
The makers of Tylenol have recalled more than 20 types of children’s and infant’s medications as a precaution against possible contamination. The liquid products were being voluntarily pulled from stores and warehouses because bacteria were detected in one of the inactive ingredients, the company said.
The ingredient with the bacteria was not used in packaged Tylenol products sold in stores, but was manufactured at the same time.
The company did not announce whether any children had been sickened by the medicines.
The recalled products include: Children’s Tylenol Cold MS Suspension 4 oz. Grape, Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry, and Infant’s Tylenol Suspension Drop 1 oz. Grape.
The recalled products were made between April and June 2008. The recall involves only liquid Tylenol products. Consumers with concerns about the recalled products are asked to call McNeil Consumer Call Care Center at 1-800-962-5357.
Click here for the full report from MSNBC
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.
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
Finally!! The mainstream media and the FDA are opening their eyes to what Kevin’s been saying all along, that prescription and non-prescription drugs are hurting you!!
FDA says Acetemenophen is Dangerous
Anti-Psychotics Increase Risk of Suicide
Bayer Contaminates US Rice
Dr. Rima Laibow-Natural Doctor
Suzie Cohen-Natural Pharmacist
Birth Control is Dangerous
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