Potential Psych Warning On Flu Drugs - FDA

FDA mulls psych warning for 2 flu drugs

U.S. Food and Drug Administration staff have recommended new warnings about psychiatric side effects seen in some patients taking Tamiflu and Relenza, according to documents released Friday.

An FDA advisory panel will review the recommendations for the anti-viral influenza drugs at a meeting next week.

It based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

In the case of Tamiflu, "the number of cases continues to increase," FDA staff wrote, in one of several documents posted ahead of the meeting.

The panel meeting will be the third public meeting on the safety of Roche Holding AG's Tamiflu, originally prompted by reports two years ago of a dozen deaths of children in Japan who had been taking the drug.

Experts then found no evidence of a direct connection between the drug and the deaths, although the FDA did ultimately update Tamiflu's label to add a caution urging close monitoring of patients for abnormal behaviour such as delirium or self-injury.

In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened further to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

Consumer group Public Citizen chided the agency for failing to note the reported adverse events earlier on the label.

"What is the justification for not warning people for these adverse events that have clearly occurred?" said Dr. Sidney Wolfe, head of Public Citizen's health research arm.

"Japan has said, 'stop using the drug if these things occur.' In [the U.S.], we haven't even mentioned that deaths have occurred."

Hallucinations, delirum seen in Relenza patients

In March, Japan warned against prescribing Tamiflu to young people aged 10 to 19 as more than 100 individuals, mostly young, showed signs of abnormal behaviour after taking the drug.

Earlier this year, Japan broadened its probe of Tamiflu to look at amantadine and GlaxoSmithKline Plc's Relenza.

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behaviour" observed in some patients taking the drug.

The current Relenza label has no label warning related to psychiatric events.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

It will present the advice to the advisory panel of experts meeting on Tuesday. The agency typically takes the advice of these panels but is not bound by them.
Source: CBC.ca

Resist the Drag and Clear the Air

Source: Women's Health September 2007

Shower Savings

Source: Women's Health November 2007

High lead levels found in children's umbrella

Parents are being urged to return a children's umbrella because it contains lead in excess of allowable limits under the Canadian Hazardous Products Act.

The Yellow Duck Handle Kids Umbrella, which comes in two different looks, has the style No. 79WWM.

Health Canada and A.C.I. Accessory Concepts of Oakville, Ont., which issued the joint urgent recall on Monday, said no injuries or illness have been reported. Lead is toxic if ingested by young children and can cause adverse health effects.

Approximately 2,000 umbrellas were sold at Wal-Mart stores throughout Canada from January 2005 to Oct. 15, 2007.

The umbrellas can be returned for full refunds at point of purchase. No sales receipt is necessary. If umbrellas aren't returned, consumers are urged to carefully dispose of them so they cannot be reused.

For more information, consumers can call A.C.I. Accessory Concepts at (905) 829-1566 ext. 234.

Source: CBC.ca

Tread the Green Path with An Open Eye

Consumers Warned: Beware Of "Green" Product Claims

If businesses love one thing in their marketing it's riding a trend. And going green is definitely one of them. From hybrid vehicles to environmentally friendly aerosols, there's no shortage of items you can buy that promise you're getting a product you need while saving Mother Nature's hard-done-by hide.

But just when does that 'green' turn a shade of gray? According to a survey by Toronto-based environmental marketer TerraChoice, the answer may be a lot more often than you think. The organization sent researchers into six big box stores to look for every environmental claim made in the products sold there and wound up recording more than 1,000 of them in goods ranging from shampoo and air fresheners to mouthwashes and light bulbs. They found consumers aren't getting the straight goods from businesses that claim to be doing favours for the environment.

The vast majority of products marked as friendly to the planet contained labels that were either misleading or so vague it was hard to figure out what they were really saying. The organization refers to something it calls "greenwashing, a term defined as false environmental advertising designed to pull the synthetic wool over your eyes.

They claim advertisers know you want to help the environment and think nothing of making you believe you're doing just that. How bad did it get? Consider this: they say all but one of the 1,018 products surveyed "made claims that are either demonstrably false or that risk misleading intended audiences."

Among them: paper products that trumpeted they were 10 per cent recycled, leaving questions about where the other 90 per cent came from; items whose labels scream "all natural", without saying what that really means. The group points out poisons like arsenic and mercury all are natural, too.

Then there are the CFC-free designations, even though chlorofluorocarbons were banned three decades ago. "What that claim basically says is: 'We're obeying the law.' Well, whoop-de-do," observes TerraChoice's Scott Case sarcastically.

And there's also the issue of hypocrisy. The group cites a dishwashing detergent that came in a box made of 100 per cent recycled paper - but was wrapped in never-degrading plastic wrap.

"We began to anecdotally observe a dramatic increase not only in the number of green claims in the marketplace, but also in the general lack of trustworthiness and effectiveness of much of that green marketing," notes TerraChoice's Stewart McDougall. "(Marketers) risk misleading their intended audiences."

The watchdog points out "six sins" it says marketers use liberally throughout their claims, a pattern that occurs over and over. The list:

1. The Hidden Trade-Off: like "energy-efficient" electronics that contain hazardous materials or recycled paper that used inefficient energy to make it.

2. No Proof: Among them: shampoos claiming to be "certified organic," with no verifiable evidence of that claim.

3. Vagueness: These are goods that don't exactly spell out what they mean and only skirt around their supposed environmental value. An example? Anything that claims to be chemical free. Chemicals are in just about everything - including the make-up of humans and animals. Also watch for "non-toxic", "all-natural", "environmentally-friendly", and "earth-friendly" which can sound good but mean nothing.

4. Irrelevance: The CFC instance cited above is a classic example of saying what's not there and never should have been.

5. Fibbing: Products that boast the backing of internationally known environmental groups when in fact there's no relation to any of them and they didn't give an endorsement.

6. Lesser of Two Evils: A bit subjective, but it's like putting perfume on a skunk. It still stinks, but maybe just a little less. Organic cigarettes or a hybrid SUV fall into this category. Better not to use either, researchers say.

None of it surprises the men in green. "Marketers are ... desperately grabbing for any environmental claim they can slap on the label because they think it will help them sell more products," Case observes.

The survey is eye-opening, but not always that helpful because those behind it have refused to release the names of the products they tested and found deficient. So what can you do if you can't tell green from greed? Case suggests looking for a label from a government agency called EcoLogo, a non-profit group that marks verified environmentally friendly items. For a list of the more than 7,000 North America-wide products they've approved and the reasons they passed, click here.

And remember that while many companies really do care about the environment, in the end the real green they're interested in is the stuff in your wallet.
Source: CityNews.ca

Benefits of Exercise Education Reaped in 65+

Retraining promotes physical fitness in seniors: study

Attribution retraining" may be the key to convincing seniors that advanced age is no excuse for
being physically unfit, according to American researchers.

Scientists at the University of California, Los Angeles used the technique, which changes a person's perceptions and patterns, to boost seniors' activity levels.

"We can teach older adults to get rid of those old beliefs that becoming sedentary is just a normal part of growing older," Dr. Catherine Sarkisian, assistant professor of geriatrics and the study's lead author, said in a release.

Four times a week, the study's 46 participants — all over the age of 65 — were taught in hour long sessions that activity can continue in old age.

The seniors then participated in exercise classes of the same duration and frequency. The classes focused on exercises that increased stamina, flexibility and strength.

During the seven-week study, the participants were fitted with electronic pedometers that counted how many steps they walked each week. They also filled out surveys that were meant to determine their views on aging and fitness.

Over the course of the pilot program, the people involved in the study increased the number of steps they took weekly from a mean of 24,749 to 30,707, an increase of 24 per cent.

The study was published online Thursday in the Journal of the American Geriatrics Society.

The study's participants also reported higher energy levels, less pain and an improvement in the quality of their sleep.

As for their views on exercise and aging, there was a 30 per cent increase in positive feelings towards aging and exercise, the researchers found.

Source:CBC.ca

Health Canada Foreign Product Usage Warning

Health Canada is advising consumers not to use 2 foreign health products due to concerns about possible side-effects:

Royal Medic No.1 Chinese Caterpillar Fungus is a proprietary Chinese medicine promoted as a general health tonic. Health Canada advises Canadians not to use this product due to microbial contamination.

Steripaste Medicated Paste Bandages may not be sterile therefore there is a possibility the bandage may cause a wound infection.

Source: HealthCanada