HotDog Recall - Incomplete Listeria Testing

Maple Leaf recalls wieners, citing incomplete listeria testing

Maple Leaf Foods has voluntarily recalled hundreds of cases of wieners that had not completed tests for the listeria bacteria species.

The affected products were shipped to Eastern Canada, mostly to Ontario, Maple Leaf spokeswoman Linda Smith told CBC News.

People who have purchased 450 gram packs of Shopsy's Deli Fresh All Beef Frankfurters (product code 20730 and UPC 6487520730, best before date of April 22 and 23) and Maple Leaf Hot Dogs (product code 22356 and UPC 6310022356, best before date of April 23) are advised not to consume them.

Smith said 1,100 cases of wieners were quarantined for a second round of testing at a plant in Hamilton, Ont., but they were mistakenly shipped out prematurely. Initial testing revealed a partial positive result for a listeria species, Smith said. Maple Leaf says it tests for all six listeria species, not just Listeria monocytogenes.

It is not known whether the recalled wieners have tested positive for Listeria monocytogenes, a species that can be fatal in humans and was blamed for last year's deadly listeriosis outbreak.

More listeria-related recalls likely: McCain

"Unlike other situations, this event occurred as a direct result of human error and did not uphold our stringent industry leading protocols," said Michael McCain, president and CEO of Maple Leaf Foods.

Smith said the recalled shipment is small — there are 12 packs of wieners in each case. She estimated that each pack contains between 10 and 12 wieners. Maple Leaf expects to have all the recalled wieners in its possession by tomorrow morning at the latest, she said.

The company said the wieners are being taken off shelves "immediately," and that the Canadian Food Inspection Agency is overseeing the recall. Maple Leaf said no illnesses were reported as a result of consuming the wieners, and that "the risk to human health is extremely low."

"As we have seen with the wide range of food products which have been recalled to date in 2009, as enhanced surveillance becomes more pervasive in the food industry, positive listeria findings and related recalls will occur more frequently," said McCain.

"This should be regarded positively as it provides assurance that the industry and government are acting swiftly to protect public health."

According to the Canadian Food Directorate, one to 10 per cent of all prepared food contains listeria.

Maple Leaf is still dealing with fallout from the company's involvement in last year's listeriosis outbreak. The deaths of 17 people were linked to meat contaminated with Listeria monocytogenes produced at a Maple leaf plant in Toronto last summer.

Source: CBC.ca

SuperSize Toxicity - French Fries under Fire

French-fry chemical may go on toxic list

Worries that Canadians might be inadvertently ingesting too much cancer-causing acrylamide from French fries, potato chips and other processed foods has prompted Health Canada to recommend adding the chemical to the country's toxic substances list.

Acrylamide is an industrial chemical that isn't naturally found in foods, but is produced accidentally when sugars and other items in potatoes and grains are exposed to high cooking temperatures.

It has also been detected in breakfast cereals, pastries, cookies, breads, rolls, toast, cocoa products and coffee, although at levels far below those in fried potato products.

The decision to recommend placing acrylamide on the toxic list is being announced in today's Canada Gazette, and is part of an ongoing review by the federal government of nearly two hundred potentially harmful substances in widespread commercial use that have never been subject to extensive safety assessments.

The gazette notice on the chemical, which was posted on the Internet yesterday afternoon, said the toxic listing was based on the "carcinogenic potential" of acrylamide and the lack of an adequate safety margin at current exposures for causing reproductive and developmental harm during fetal and early life development.

The government didn't announce specific steps to control exposures to acrylamide in fries and chips, but said that it planned to use the Food and Drugs Act "to reduce the inadvertent production of acrylamide in certain processed foods intended for human consumption."

Acrylamide is also used to make polymers found in grout, cement, waste water treatment, pesticides, cosmetics, and diapers, among other products. The data posted by the government didn't give any indication that these non-food uses would be regulated.

The toxic announcement was greeted positively by environmentalists, who have been arguing that potentially dangerous chemicals in consumer goods need to be limited.

"We think it's particularly important to list the chemicals that are in common, everyday items," said Aaron Freeman, a spokesman for Environmental Defence, a Toronto-based advocacy group. He said the government should move quickly to introduce control measures.

Source: theGlobeandMail.com

Crib Recall - Health Canada

Health Canada recalls crib

Health Canada is asking parents to stop using a particular crib that was manufactured in Chile and imported to Canada by Bambino Reale Furniture, a company that's gone out of business.

There is a potential for a serious fall-related injury, although to date Health Canada says it hasn't received any reports of injuries related to these cribs.

The model number is 612C19CH.

Because the company, a subsidiary of Quebec-based Ragazzi Furniture, has gone out of business, Health Canada hasn't been able to determine how many of the cribs were sold in Canada, or when they were sold.

The warning was issued following a complaint by a consumer in Alberta and a determination that the cribs don't meet labelling and minimum side height requirements for cribs.

Health Canada says the cribs don't provide an adequate barrier to prevent infants and young children from falling out or climbing out.

The cribs should be disassembled and disposed of in a way that they won't be used again.

Source: theGlobeandMail.com

Listeria Food Recall

Listeria concerns prompt recalls

A health warning has been issued for two products the Canadian Food Inspection Agency says may be contaminated with the Listeria bacteria.

One is egg salad manufactured by Plaisirs Gastronomique Inc. of Boisbriand, Que., and included in some Ziggy brand egg salad sandwiches. These Ziggy's brand products bear a best-before date up to and including Feb. 17 and are distributed in Ontario and Quebec.

The warning also covers various products containing egg salad at some chain stores and other retailers and deli stores in Quebec and Ontario.

Consumers who bought the affected products between Feb. 2 and Feb. 17 are advised to check the retailer to see if they have the recalled products.

The agency has issued a similar warning for Kanata Smoke House brand Smoked Atlantic Salmon sold from Costco stores in Quebec. The product is sold in 500 gram packages (bearing UPC 8 19269 00350 5 and Product code 3001 Best Before 2009 FE
Source: theGlobeandMail.ca

Ontario Promotes New Health Info Site

Ontario touts new service to help Ontarians find an MD, neighbourhood clinics

Ontario has announced a program aimed easing the pressure on hospital emergency rooms by linking patients with family doctors and clinics close to home.

Emergency departments see more than five million patients every year, and about half of those visits are for non-urgent conditions.

Health Minister David Caplan says the new service will help people get the care faster and closer to home.

Health Care Connect is a hotline — 1-800-445-1822 — staffed by nurses that residents can call to help find a family health-care provider.

The province has also compiled health information on a website that contains details about health-care facilities.

http://www.health.gov.on.ca/ms/healthcareoptions/public/index.html

The site allows residents to type in a postal code and find the nearest walk-in and after-hours clinics, urgent care centres, family health teams, general practitioners and emergency rooms.

The government is also pledging to expand the site to offer information on all front-line health services in Ontario, including community care centres, laboratories and long-term care homes.

Source: CBC.ca

Atkins Granola Bar Warning - Canadian Food Inspection Agency

Granola bar may contain contaminated peanuts: CFIA

The Canadian Food Inspection Agency warned the public on Wednesday not to eat the Atkins Advantage Peanut Butter Granola Bar because it may be contaminated with salmonella.

The granola bar, manufactured in Canada, comes in 48-gram packages and carries best-before dates of June 6, 2009, and July 19, 2009.

The agency said the granola bar contains peanut products that have been recalled in the U.S. and Canada by the Peanut Corporation of America as a result of a salmonella outbreak that has made 600 people sick in the U.S. The outbreak may be linked to eight deaths.

Canadians were also warned not to consume chocolate-covered peanuts, including sugar-free ones, sold in unmarked, clear plastic, cone-shaped containers with gold foil tops, by Golden Chocolate in Lakeshore, Ont.

The chocolate-covered peanuts, manufactured in the U.S., come in 220-gram and 440-gram packages.

The warning also applies to Sunbird Snacks yogurt trail mix, health mix and chocolate peanut butter blast, all manufactured in the U.S. but which may have been available in Canada.

"This is an ongoing food safety investigation," the agency said in a news release Wednesday.

The agency said it is working with the U.S. Food and Drug Administration to identify and remove all affected products imported into Canada from the U.S.

CFIA is also working with Canadian manufacturers to recall foods containing affected U.S. peanuts.

The salmonella outbreak has led to the recall of more than 1,800 products in the U.S. and more than 200 products in Canada.

Peanut Corp. is currently being investigated by the Federal Bureau of Investigation in the U.S. Its corporate headquarters in Lynchburg, Va., were raided by the FBI on the weekend, and two of its plants, one in Georgia and the other in Texas, have been closed while the investigation continues.

It makes only about one per cent of U.S. peanut products, but its ingredients are used by dozens of other food companies.

Source: CBC.ca

First Genetically Altered Drug from Goats Approved by FDA

Drug from genetically altered goats approved by U.S. regulator

The U.S. Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.

GTC Biotherapeutics said regulators cleared its drug ATryn, which is made using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.

The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists.

Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be sold in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals.

About one in 5,000 people don't produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death.

Clots threaten placenta

Pregnant women with the disorder are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.

Patients with hereditary antithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval.

ATryn is only approved for use when patients are getting surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.

To make the drug, scientists at GTC put DNA for the human antithrombin protein into single-cell embryos of goats.

Goat embryos with the gene were then inserted into the wombs of surrogate mothers, who gave birth to baby goats that produce the protein-charged milk.

Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic.

Amid growing questions about the technology, the FDA last month issued guidelines for how it will regulate products made from genetically altered animals.

FDA said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The agency's panel of blood product experts recently concluded ATryn was safe and effective.

But consumer groups said the FDA's long-awaited policy will not require all genetically engineered foods to be labelled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment — particularly if some escape and begin to mate with animals in nature.

The drug received European approval in 2006.

Shares of GTC Therapeutics rose five cents, or 5.5 per cent, to 87 cents in midday trading.

Source: CBC.ca

Canada Adds 8 Chemicals to Toxic List

Government adds 8 chemicals to list of harmful substances

Ottawa has designated eight chemicals as being of concern to human health or the environment following its latest assessment of potentially dangerous substances.

The designated chemicals include silicon-based D4 and D5, which are used in a wide range of cosmetic products.

The joint assessment by Health Canada and Environment Canada means the chemicals can now be regulated. The latest assessment is part of a process of reviewing 200 chemicals in batches of up to 30 to determine whether they pose a risk to human health or the environment and should be more closely regulated.

It's the same process under which the federal government announced it would ban the import and sale of baby bottles made with bisphenol A.

Interested parties now have 60 days to comment on any risk management that may be required in the case of the eight newly named chemicals.

Of the eight chemicals placed on Ottawa's list, D4 and D5, along with TTBP, a fuel and oil additive, are not considered a threat to human health but are listed as of concern to the environment, including wildlife.

The ministers of health and environment issued a joint news release Tuesday stating "regulations will be developed to set a concentration limit for siloxanes D4 and D5 in products and for wastewater generated during the manufacturing process.

"The third substance [TTBP] will be managed so that releases to the environment will be reduced below levels that can be measured."

Harm to environment, carcinogenic effects among dangers

D5 is used in pharmaceuticals, cosmetics and cleaners as well as inks, textiles, rubbers and fuel additives. It is considered bioaccumulative and can harm aquatic organisms at low concentrations.

D4 is another silicone fluid used in types of rubbers, plastics, soap, pharmaceuticals, and cosmetics — including creams, lotions, hair care products and antiperspirants — as well as pesticides, paints, lacquers, varnishes, inks, textiles, leather goods and fuel additives.

Ottawa has said experimental data shows that D4 is persistent in the environment and can harm aquatic organisms at low concentrations.

Tuesday's release also lists five other chemicals as of concern to human health. They are thiourea, Pigment Yellow 34, Pigment Red 104, isoprene and epichlorohydrin.

Thiourea is used to extract silver and gold from ore and occurs naturally in some plants and fungi. Europe and the U.S. have classified it as a compound that should be examined as a possible carcinogen.

Pigment Yellow 34 and Pigment Red 104 contain chromium and lead and are used to colour plastics, inks, paints, coatings, adhesives, textiles and sealants. In addition, the European Commission classified Pigment Yellow 34 based on concerns that it may be carcinogenic and toxic to the reproductive system.

Isoprene is used to make medical equipment, toys, tires and paints, inner tubes, and some rubber adhesives and glues. The federal government decided to take a closer look at this chemical after other jurisdictions classified it as a possible human carcinogen.

Epichlorohydrin is a synthetic chemical used to make other chemicals and is classified as a possible human carcinogen by the European Commission and the United States Environmental Protection Agency.

Source: CBC.ca

Biphensol - Additional Concerns Part 2 - Canned Food

Source: Men's Living Jan 2009

Bisphenol May Stay in System Longer - Study

Bisphenol A, a chemical used to make many hard plastic products, may stay in the body longer than previously thought.

Researchers say the finding may also mean that people are ingesting the chemical from non-food sources.

In Wednesday's online issue of the journal Environmental Health Perspectives, Dr. Richard Stahlhut of the University of Rochester's Environmental Health Sciences Center said high levels of BPA remained in the body after people in a study fasted for as long as 24 hours.

In October 2008, Canada became the first country in the world to ban the import and sale of polycarbonate baby bottles containing bisphenol A, citing concerns about exposing infants to the chemical.

Late last year, the U.S. Food and Drug Administration said it planned more research into the safety of BPA, but the agency indicated no immediate plans to follow Canada's curb on the chemical.

In the latest study, Stahlhut and his colleagues looked at BPA levels in the urine of 1,469 U.S. adults who took part in a government health survey.

The researchers said they expected to see a relationship between the last meal, fasting time and BPA levels.

Based on the assumption that BPA is excreted quickly and people are exposed to the chemical mainly through food, much lower BPA levels were expected among those who fasted for 24 hours than those who fasted for 8.5 hours.

Safety assumption questioned

"Our results simply do not fit that picture," said Stahlhut.

"The research community has clues that could help explain some of these results, but to date the importance of the clues have been underestimated. We must chase them much more vigorously now."

BPA levels appeared to drop about eight times more slowly than expected, he added.

The researchers proposed two possible explanations for the higher-than-expected levels among people who fasted:

• Exposure to BPA from other sources, such as house dust or tap water.
• BPA may seep into fat tissues, where it is released more slowly.

"The finding is surprising and a little disturbing, in that all assumptions about the safety of BPA made by regulatory agencies are based on the idea that we are primarily exposed to this from eating," Fred vom Saal, a professor of biological sciences at the University of Missouri-Columbia Division of Biological Sciences, told HealthDay News.

To find out, more research is needed to evaluate the effects of BPA on fat tissue hormones and function, and to compare BPA levels in fat, blood and urine, Stahlhut said.

Bisphenol A is a chemical compound found in some hard, clear, lightweight plastics and resins. It's used in the production of various types of food and drink containers, compact discs, electronics and automobile parts, and as a liner in some metal cans.

Animal studies suggest that, once ingested, BPA may imitate estrogen and other hormones, according to the U.S. National Institutes of Health.

In a study published in September 2008 in the Journal of the American Medical Asssociation, adults with higher BPA levels in their urine were linked to higher risks for heart disease and diabetes.

The American Chemistry Council, which represents makers of BPA, maintains that the chemical is safe for all uses. Steven Hentges, spokesman for the trade group, dismissed the study's conclusions as "speculative at best."

Source: CBC.ca

Blood Pressure Drug Combo Can Be Deadly

Blood-pressure drug alert issued

Taking two commonly prescribed blood-pressure drugs in combination can trigger severe heart and kidney problems, according to an alert issued Friday to patients and physicians.

The drugs, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, are considered safe and effective on their own and when combined with other hypertension drugs, but ACE inhibitors and ARBs should not be used together, the Heart and Stroke Foundation is warning.

The group estimates that about 175,000 Canadians – most of them over the age of 65 – are taking this particular combination of drugs.

“This is a safety issue that the public and practitioners need to be aware of,” said Sheldon Tobe, a nephrologist at Sunnybrook Health Sciences Centre in Toronto. “Bringing blood pressure under control is very important, but with this particular combination the potential risks outweigh the benefits.”

Margaret Moy Lum-Kwong, director of high-blood-pressure strategy at the Heart and Stroke Foundation of Ontario, stressed that patients should not stop taking medications, even if they are taking ARBs and ACE inhibitors together, but discuss the matter with their physician.

“If you are on this particular combination treatment … go directly to your doctor for an alternative treatment,” she said.

High blood pressure, the leading risk factor for heart disease, is commonplace, affecting one in four men and one in five women.

A person is considered hypertensive with a blood-pressure reading of 140/90 millimetres of mercury (mmHg) or higher. Healthy adults should have a blood pressure in the range of 120/80 mmHg, although that target varies with age and other health conditions such as diabetes.

According to a study published last year, about 85 per cent of those with high blood pressure are aware of their condition and most are being treated successfully.

Blood pressure can often be controlled with lifestyle changes such as weight loss, healthy eating (particularly reducing salt consumption) and exercise, but many Canadians are treated with prescription drugs.

About two-thirds of hypertensive cases are treated with combinations of drugs, including diuretics, ACE inhibitors, ARBs and calcium channel blockers.

The safety and effectiveness of various combinations is being studied systematically. Last year, a landmark Canadian-led study showed that the combination of an ACE inhibitor and ARB was only marginally more effective at lowering blood pressure than either drug taken alone.

But it also revealed far more side effects among those taking the ACE-ARB combo, including fainting, diarrhea and dangerously elevated potassium levels that could result in kidney failure (and the need for dialysis) and even death.

Dr. Tobe stressed that severe complications were rare, but said there is no justification for putting patients at risk when there is no additional benefit.

“What we're doing here is refining therapy to make it safer,” he said.

Arthur Innes, a 57-year-old Torontonian who works in a long-term care facility, said he got his blood pressure checked as part of a physical for life insurance and was shocked to learn readings were dangerously high at 200/90 mm/Hg.

His family doctor prescribed a combination of ARB and ACE inhibitor. “These medications didn't make me feel very good. I was dizzy and had nausea all the time,” Mr. Innes said.

He was referred to a specialist and prescribed different medication; he now has his blood pressure under control and suffers no side effects.

“Taking the meds is important for your heart,” Mr. Innes said, “but you don't want medications that impair your way of life.”

Source: theGlobeandMail.ca

Botox Can Spread - Health Canada Warning

The toxin in Botox products may spread to distant parts of the body, with potentially fatal consequences, Health Canada said Tuesday in announcing new labelling information for the drugs.

Last February, the U.S. Food and Drug Administration said the toxin had spread, both in products the agency approved and those that were not. Health Canada has been reviewing the safety of Botox and Botox Cosmetic.

No medically confirmed cases of the toxin having spread have been reported in Canada.

In its advisory, Health Canada said the symptoms of "distant toxin spread" include:

• Muscle weakness.
• Difficulties swallowing.
• Pneumonia.
• Speech disorders.
• Breathing problems.

Botox, made by Allergan Inc. of Irvine, Calif., is approved for treating muscle spasms in the neck, eye and foot, muscle pain and excessive sweating in Canada. Botox Cosmetic, which is made by the same company, is approved to treat facial wrinkling.

The drugs use botulinum toxin, which blocks nerve impulses to muscles, causing them to relax.

People with a history of neurological disorders, swallowing difficulties or breathing problems should be extremely cautious about using the products, Health Canada said.

When the U.S. issued its warning, the FDA said the deaths were all among children. Most had cerebral palsy and were being treated for limb spasms, which is not an approved use for the drugs in the U.S. or Canada.

Health Canada has worked with Allergan to revise the labelling, and will continue to monitor the safety of Botox products, the department said.

Vicks VapoRub Harmful to Kids

Cold ointments may spell serious breathing problems for children

As far as home remedies go, it's right up there with chicken noodle soup. But parents who use Vicks VapoRub to help their children get over a cold may, in some instances, do more harm than good.

A new study published today in the journal Chest warns that putting the mentholated ointment under or in a child's nostrils can prompt mucus production and cause serious breathing problems.

"I think it will surprise some folks because it is used this way," said Bruce Rubin, professor and vice-chairman for research in the pediatrics department at the Wake Forest University School of Medicine in North Carolina and lead author of the study.

Although health professionals and product manufacturers have long known that using Vicks VapoRub and similar generic products on children can present risks, many parents may not be getting that message, Dr. Rubin said.

"I think most people aren't aware of [the risks] and I think most people don't read the warning label," he said.

The label on Vicks VapoRub, for instance, advises parents to consult a physician before using the product on children under age 2. A warning also states that the product shouldn't be rubbed in the nostril.

But the study said many parents or caregivers may miss, or even ignore, this warning, not realizing the harmful effects the product can have on very young children.

Dr. Rubin and his colleagues embarked on the study after taking care of an 18-month-old girl who was brought to the hospital with severe breathing problems. Doctors couldn't figure out what had caused the girl, who was suffering from a cold and hadn't been given any medication, to suddenly experience "severe respiratory distress."

After asking the child's grandparents to think of anything they may have done before she began to have trouble breathing, her grandmother said she had put Vicks under her nostrils less than an hour before.

After the child recovered, doctors at the hospital began to routinely ask about the use of mentholated ointments and found several cases were similar.

Researchers then began a study using ferrets, which have a similar airway to humans, to determine what could be causing the problem among young children. They found that Vicks VapoRub causes an increase in mucus, which can lead to serious problems among children. A child's airway is tightened and narrowed by a virus, and thus a significant increase in mucus can lead to serious breathing difficulties like those noted by Dr. Rubin and his colleagues.

That's not to say mentholated ointments don't provide relief. In adults, they deliver a cool sensation that tricks the brain into thinking airflow is increasing. In reality, the preparations don't act as a decongestant or help a person to breathe better. But they do make a person feel like they can breathe better, helping them feel more comfortable as they fight a cold.

The warning about the menthol-based ointment is particularly timely, considering health officials are moving to restrict the use of over-the-counter medications in children.

Last month, Health Canada warned that cough and cold medications shouldn't be given to children under 6 because there isn't enough information to prove they're effective. These medications were linked to some health problems among children in Canada in recent years, including five deaths.

It's possible the new restrictions on cold medications may prompt some parents to look more closely at alternative or home remedies to help their children. If that's the case, parents must understand that over-the-counter remedies that are used safely in adults could cause serious problems in kids.

"You need to be aware that unless these are studied in children, there might be unrecognized risks," Dr. Rubin said.

A Canadian pediatrician agreed that parents should be wary of giving children over-the-counter cold remedies, even if they're considered to be natural.

"A lot of the natural products on the market have not been tested," said Danielle Grenier, medical affairs director at the Canadian Paediatric Society. "Even if it's a natural product, it still has ingredients. We know that it can have side effects."

The best advice she has for parents is to rely on the simplest solutions to help your child through a cold: plenty of warm liquids and a lot of rest.

"They're still the best," Dr. Grenier said.

Source: TheGlobeandMail.ca

Quit Smoking Drug Safety Notice - Health Canada Update

Health Canada says it is in the process of strengthening safety information on the labels of the smoking-cessation product Champix.

In a statement Tuesday, it said it's working with the drugmaker Pfizer to update prescribing information after reports of serious psychiatric symptoms associated with the use of Champix.

Health Canada says label changes that increase awareness of the risk will be passed along to consumers and medical professionals when they are finalized.

Champix can be an effective tool for quitting smoking, it says, but there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others.

Health Canada says people taking the drug and their families are reminded to be aware of any unusual thoughts, feelings or behaviours, especially those related to depression, aggression or self-harm.

It isn't clear whether Champix is the cause of these psychiatric symptoms, but patients should stop the drug immediately if there are such concerns.

And patients should avoid driving or operating machinery until they're sure that Champix doesn't have an adverse effect on them, Health Canada said.

In issuing its reminder Tuesday, the federal agency noted that it's a time of year when many smokers are attempting to kick the habit.

In Montreal, Pfizer spokesman Christian Marcoux said that Champix is "safe and very efficacious" and that some symptoms are actually caused by the act of quitting smoking.

"Any individual attempting to quit smoking should be monitored and work with their physician because smoking cessation will generate or exacerbate such symptoms, with or without medication," he said.

He said the simple fact of quitting smoking will trigger behavioural changes.

"Smoking is a very nasty addiction and it's quite a challenge to work on that addiction," he said.
Source: CBC.ca, Health Canada

Beware FDA Changes to Guidelines

Change in FDA's ethical guidelines for clinical trials troubling: Lancet

The Lancet medical journal is reporting that the United States Food and Drug Administration is abandoning the Declaration of Helsinki as an ethical foundation for international clinical trials.

The declaration was drafted in 1964 by the World Medical Association to provide binding ethical standards for medical research involving humans.

Many basic patients' rights are enshrined in the declaration. Sections of it also govern business and environmental practices of the researchers.

The FDA is instead adopting the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP), which allows less stringent ethical standards for overseas research.

In a commentary published in the Jan. 3 issue of the Lancet, medical research experts Jonathan Kimmelman of McGill University, Charles Weijer of the University of Western Ontario and Eric Meslin of the University of Indiana call the move "troubling."

The authors urge the incoming U.S. administration of president-elect Barack Obama to stick to the original declaration pending a review of the implications for American research overseas should the new guidelines be adopted.

"The FDA regulates the largest drug market in the world, and we worry that its replacement of the Declaration of Helsinki with a less morally authoritative document may cause others to follow suit, thereby undermining international ethical standards for research," they write.

In October 2008, the FDA formally stopped requiring that foreign clinical studies supporting applications for drug licensing comply with the declaration.

The authors point out several important requirements that the declaration contains but the GCP lacks, including:

* Investigators must disclose funding, sponsors and other potential conflicts of interest to both research ethics committees and study participants.
* Study design must be disclosed publicly (e.g., in clinical trial registries).
* Research, notably that in developing countries, must benefit and be responsive to health needs of populations in which it is done.

Source:CBC.ca

Snooze and Lose - New Study

Why You Shouldn't Hit Your Snooze Alarm

It's the most tempting thing in the world - your alarm clock goes off to wake you up in the morning. You reach for the snooze button to get an extra few minutes of sleep. It's something you've likely done often as the daily ritual of getting up just a bit too early, staying up just a little too late and working just a few too many hours catches up to you.

But you shouldn't.

That simple act of getting back to sleep may be costing you mentally. Studies show the brain produces a "wake-up" neuron called orexin, designed to help you feel more alert in the morning. It combines with activity neurons that make it harder for you to fall back into the land of nod.

But hitting the snooze alarm doesn't always create the necessary cycle that allows them to both work together. And scientists say it appears that's why so many people appear "dozy" during the day - they simply didn't let the natural processes that involve waking actually happen. The result: a long hangover effect the more you hit that time delay switch.

best bet to stop the effects of too little sleep is to make sure you get the most from your down time. Here are some ways to do it:

• Establish regular bed and wake times.
• Avoid consuming alcohol near bedtime.
• Avoid caffeine in coffee, tea, colas after 4pm
• Don't use your bedroom for doing work or problem-solving. Use it only for sleep or sex.
• Take a hot bath before bed.
• Keep your bedroom cool.
• Place the bedroom clock out of reach and facing away. Looking at the clock can aggravate sleep problems.
• Have a light snack before bedtime: Foods rich in the amino acid tryptophan, such as milk and turkey, can help you sleep. But avoid heavy or fatty meals, which can cause acid reflux, too close to lights out.
• If you frequently wake up to urinate during the night, cut back on fluids near bedtime.
• If your partner snores, sleep in a separate bedroom or get a good pair of earplugs.
• If lying in bed and unable to sleep, get up and go back when you feel sleepier. Don't lie there stewing.
• Seek medical help if you can't sleep for long periods of time.

Source: CityNews.ca

Anti-Smoking Drug's Adverse Effects

Smoking drug Champix linked to adverse psychiatric effects: Health Canada

Health Canada has issued a warning about adverse neuropsychiatric effects linked to Champix, a drug intended to help smokers butt out for good.

A number of patients taking Champix (varenicline tartrate) have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, Health Canada said Friday in an advisory.

The medication acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

Champix, made by Pfizer Inc. and sold under the brand name Chantix in the United States, has been sold in Canada since April 2007. In the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported. In that period, more than 708,500 prescriptions for the drug have been filled across the country.

Health Canada issued the following guidelines to the public:

• Tell your doctor if you have experienced depression or other mental health problems before taking Champix, as these symptoms may worsen while taking the drug.
• Stop taking Champix and tell your doctor right away if you, your family or caregiver have noticed any of these symptoms, if you experienced these symptoms in a way that is not typical for you or if you have thoughts of self-harm or of harming others.
• Champix has not been studied in people with mental health problems, and therefore your doctor will be monitoring you closely for new or worsened emotional or behavioural problems while on the medication.

"Quitting smoking can also be associated with changes in mood and behaviour, with or without taking medication to help quit," said the federal department in its advisory. "A doctor or pharmacist should be consulted should these symptoms or those described above be experienced, since guidance has been provided to health-care professionals on how to use Champix in patients, including those patients who may also have mental health problems."

Health Canada, which published an article concerning Champix in the Canadian Adverse Reaction Newsletter in April, said any case of serious change in mood or behaviour or other serious or unexpected adverse reactions in patients receiving Champix should be reported.

Source:CBC.ca

Car Smoking Ban - Ontario

Ontario bans smoking in cars with kids under 16

Ontario became the latest province to ban adults from smoking in cars where children are present Monday after a government-backed bill passed in the legislature with support from all parties.

The province already bans smoking in workplaces and public areas, such as bars and restaurants. The new ban will also protect kids under the age of 16 who are being exposed to dangerous levels of second-hand smoke, said Health Promotion Minister Margarett Best.

"This is about protection of our most vulnerable citizens — children who do not have a voice," Best told the legislature.

Premier Dalton McGuinty once dismissed a province-wide ban as a slippery slope that infringed too much on people's rights, but changed his tune in March and threw his government's support behind the private members' bill.

Offenders will also face much lighter fines than originally envisioned by Liberal backbencher David Orazietti, who championed the ban. Drivers and passengers who don't butt out in vehicles carrying children won't be fined more than $250 for each offence, rather than being penalized up to $1,000.

Nova Scotia and British Columbia have already outlawed the practice, which critics liken to child abuse. Prince Edward Island and New Brunswick are also considering a similar ban.

Police will be expected to enforce the law once it takes effect, but the province is counting on most people abiding by the law, said Best.

Ontario Provincial Police have said the ban won't make their job more onerous, as they are already inspecting for seatbelts and child car seats.

The province says kids are exposed to up to 27 times the toxins when they're in enclosed spaces like a car, which can worsen asthma and lead to other respiratory illnesses.

Mychoice.ca, a smokers' rights group financed in part by the tobacco industry, has raised concerns that the ban will eventually extend to private homes, but Mr. McGuinty said that's not under consideration

Source: GlobeandMail.ca

New Drug Prevents Addiction to Smoking/Alchohol

Can exercise help prevent addiction to drugs or alcohol?

Sure, exercise is good for your waistline, your heart, your bones - but might it also help prevent addiction to drugs or alcohol?

There are some tantalizing clues that physical activity might spur changes in the brain to do just that. Now the U.S. government is beginning a push for hard research to prove it.

This is not about getting average people to achieve the so-called runner's high, a feat of pretty intense athletics.

Instead, the question is just how regular physical activity of varying intensity - dancing, bicycling, swimming, tae kwan do - might affect mood, academic performance, even the very reward systems in the brain that can get hijacked by substance abuse.

What first caught the attention of National Institute on Drug Abuse chief Dr. Nora Volkow: A study found tweens and teens who reported exercising daily were half as likely to smoke as their sedentary counterparts, and 40 per cent less likely to experiment with marijuana.

Volkow knows - from her own almost 10-kilometre daily runs and from her scientific experiments - that the brain literally likes physical activity. Exercise seems to invigorate neurochemicals that sense and reinforce pleasure

"In children, it's innate," she notes. "Children want to move."

But the nation's children are becoming more sedentary, as illustrated by the obesity epidemic, "screen time" replacing outdoor play and a drop in school phys-ed. And as youngsters approach adolescence, the run around the yard that used to be fun too often becomes a chore - the dreaded jog around the school track or the nagging to get off the couch. The sedentary teen turns into the sedentary adult.

"Why do we lose the ability to experience pleasure from physical activity?" asks Volkow.

Last week she brought more than 100 specialists in exercise and neurobiology to a two-day conference to explore physical activity's potential in fighting substance abuse, and announced $4 million in new research grants to help.

Drug treatment programs often include exercise, partly to keep people distracted from their cravings, but there's been little formal research on the effects.

The best evidence: Brown University took smokers to the gym three times a week and found adding the exercise to a smoking-cessation program doubled women's chances of successfully kicking the habit. The quitters who worked out got an extra benefit: They gained half as much weight as women who managed to quit without exercising, says lead researcher Dr. Bess Marcus.

She now is working with the YMCA on a larger, NIDA-funded study to prove the benefit.

Marcus cautions that people trying to kick an addiction have a powerful incentive to exercise. Could that possibly translate into prevention? Among the clues:

-Rats were less likely to ingest amphetamines if their cages had running wheels, suggesting exercise stimulated a reward pathway in the brain to leave them less vulnerable to the drug's rush.

-In people, exercise acts as a mild antidepressant and relieves stress. Depression, anxiety and stress increase risk of alcoholism, smoking or drug abuse.

-Volkow is intrigued that attention deficit disorder and obesity both involve problems with the brain chemical dopamine, one system that drugs hijack to create addiction.

-Baby monkeys who don't play enough in childhood have problems controlling aggression when they're older. The most aggressive tend to have defects involving the feel-good brain chemical serotonin - and binge-drink when researchers offer them alcohol.

-Back to rats, physical activity increases production of growth factors and stem cells in key brain regions important for learning and mood; increases formation of blood vessels; and strengthens communication networks between brain cells.

Together, that's far too little research to know if exercise really matters for substance abuse, scientists at the National Institutes of Health meeting cautioned.

But, a few studies of school-age children suggest physical activity predicts better performance on math, verbal and other tests - and better school performance in turn is linked to lower risk for substance abuse.

And getting sedentary seniors moving improves brain function - research aimed at preventing dementia, not drug abuse, although the improvement is in an area that in younger people is linked to risky decision-making.

A caveat: If your own youth includes memories of parties with beer-guzzling athletes, well, the research concurs. A major study that tracks adolescent risk behaviours found that by 12th grade, exercise offers no protection against binge-drinking.

"Now the kids who exercise the most actually drink the most," says Dr. Lloyd Johnston of the University of Michigan. It may have to do with the celebratory nature of team sports, or getting revved for college - or, other researchers suggested, even that competition is to blame.

Source: CBC.ca

Fast Food Weight Gain

Source: Women's Health March 2008