Health Canada warns of the dangers of topical benzocaine products

Health Canada is reminding Canadians, including parents and caregivers, about health risks associated with the use of topical benzocaine products, including a rare but potentially serious blood condition known as methemoglobinemia (MetHb). Health Canada continues to receive reports of benzocaine-related adverse reactions, including MetHb. We continue to evaluate the safety of benzocaine products in light of these reports and will take appropriate regulatory actions as warranted.

Topical benzocaine products are available over-the-counter in various concentrations and formulations, including sprays, gels, liquids and creams, and are used to relieve pain from a variety of conditions such as sore throats, teething, toothache, canker sores, irritation of the mouth and gums, burns, insect bites, itching, and hemorrhoids. They are also used by healthcare practitioners during surgical, dental and other medical procedures to numb the mouth and throat.

MetHb reduces the ability of red blood cells to deliver oxygen throughout the body. Signs and symptoms of MetHb include pale, grey or blue-coloured skin, lips, or nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; nausea; and change in heart rate. These symptoms can appear within minutes or one to two hours after benzocaine use, and can occur after the first or several uses. In rare severe cases, MetHb can progress to stupor, coma and possibly death.

Other reported side effects associated with topical benzocaine products include breathing or swallowing difficulties, a swollen tongue or mouth, irregular heartbeat, malaise, body twitching, hypersensitivity, burning, redness, itching, rash, and irritation at the site of administration. These effects can occur with any topical benzocaine product, regardless of product type or benzocaine concentration, in sensitive individuals.

As with any health product, Canadians are reminded to carefully read and follow the instructions for product use. If you think you or your child may be experiencing a side effect, including signs or symptoms of methemoglobinemia, seek medical attention. If you have questions or concerns about a topical benzocaine product, speak to a healthcare practitioner.

Health Canada first communicated the risk of MetHb in a Public Advisory and Notice to Hospitals in November 2006. Since that time, Health Canada has received seven reports of serious adverse reactions involving topical benzocaine, four of which were reports of benzocaine-induced MetHb in adults.

For a list of Health Canada-licensed benzocaine products, including topical over-the-counter products, visit Health Canada’s Licensed Natural Health Products Database(search by the ingredient name “benzocaine”) and Drug Product Database (search by the active ingredient “benzocaine”).

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Stay food safe this Holiday Season

Canadians traditionally enjoy gathering with family and friends for parties, pot lucks, and family gatherings over the holidays and these gatherings regularly generate leftovers. Health Canada would like to remind all Canadians of some basic steps they can take to ensure that leftovers are eaten safely to help reduce the risk of foodborne illness during the holiday season.

Leftovers can be very safe to eat and enjoyed as long as certain food-handling practices are followed:

Handling leftovers

  • Before and after handling leftovers, wash your hands with hot soapy water, as well as all utensils, dishes and work surfaces.
  • For added protection, you may want to sanitize utensils, dishes and work surfaces. Normal household sanitizers or a mild bleach solution (5 ml/1 tsp. bleach per 750 ml/3 cups water) may be used.
  • Keep foods out of the danger zone, between 4°C (40°F) and 60°C (140°F) to prevent the growth of harmful bacteria.
  • Throw away any cooked food left out for more than two hours.
  • Never rely on your nose, eyes or taste buds to judge the safety of food. You cannot tell if food is contaminated by its look, smell or taste.
  • When in doubt, throw it out!

Cooling leftovers

  • Refrigerate all leftovers promptly in uncovered, shallow containers so they cool quickly.
  • Very hot items can first be cooled at room temperature. Refrigerate once steaming stops.
  • Leave the lid off or wrap loosely until the food is cooled to refrigeration temperature.
  • Avoid overstocking the refrigerator to allow cool air to circulate freely.

Storing leftovers

  • Always use a clean container to hold leftovers, or wrap leftovers in leak-proof plastic bags to prevent cross-contamination. Keep different types of leftovers separate.
  • Eat refrigerated leftovers within 2 to 3 days, or freeze them for later use.
  • Date leftovers to help identify the contents and to ensure they are not stored too long.

Defrosting leftovers

  • Thaw frozen leftovers in the refrigerator or in the microwave. Ensure food is properly sealed.
  • Consume or cook the leftovers immediately after they have thawed.

Reheating leftovers

  • Reheat leftovers to a safe internal temperature of 74ºC (165ºF).
  • Use a digital food thermometer to check the temperature.
  • Bring gravies, soups and sauces to a full, rolling boil and stir during the process.
  • Discard uneaten leftovers after they have been reheated.

Reheating in a microwave

  • Use only containers and plastic wrap designed for use in the microwave.
  • Loosen the lid or wrap to allow steam to escape.
  • Stop the microwave midway through reheating and stir the food so that the heat is evenly distributed.
  • Rotate the plate several times during cooking if your microwave does not have a rotating tray.

To ensure a happy and healthy holiday season and safe food handling all year, remember these four simple rules: cook foods to proper temperatures; chill foods properly in the refrigerator; when storing leftovers, keep raw foods separate from cooked foods to avoid cross-contamination; and keep your hands, utensils and work space clean and disinfected.

It’s estimated that there are approximately 11 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

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Children’s Benadryl tablets recalled

Health Canada is informing Canadians that McNeil Consumer Healthcare (Canada) is conducting a voluntary recall of Children’s Benadryl Allergy Meltaways tablets sold in Canada. McNeil is requesting that wholesalers and pharmacies immediately stop sale of this product.

The recall of the marketed lots is being conducted as a precautionary measure since the company has   identified quality control concerns only on lots that had not been released for sale. It is important to note that no associated adverse reactions have been reported to Health Canada.

Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner or contact the company at 1-888-222-6036 or visit:  www.mcneilcanada.com.

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High blood pressure treated by nerve zap

Some people who couldn’t get their blood pressure under control through medication have found relief from an experimental treatment that shows promise as a permanent fix for the condition.

The treatment uses radio waves to zap nerves near the kidneys that fuel high blood pressure. The radio waves damage certain nerves and cause key arteries to permanently relax. The treatment is done through a tube pushed into a blood vessel in the groin, much like the angioplasty procedures for opening clogged heart arteries.

In a study published online Wednesday by British journal The Lancet, the top number of the blood pressure reading fell an average of 33 points among those who had the treatment. Doctors say that is much better than the less-than-10-point drop many drugs give.

“I am extremely interested in this,” said Dr. Elliott Antman, a Brigham and Women’s Hospital cardiologist who is vice-chairman of the American Heart Association conference in Chicago, where study results were reported Wednesday.

Even if the treatment doesn’t cure someone and is only partly successful, that’s still beneficial because these people are at grave risk of heart attacks, strokes and death, and drugs are not helping them enough now, he said.

The fact the treatment also improves blood-sugar control makes it especially attractive for diabetics with high blood pressure.

“This opens up a dramatic new option for them,” Antman said.

About one billion people worldwide have high blood pressure — readings of 140 over 90 or more. Most people need three or four drugs to treat it, and only about one-third are well-controlled on medicines. About 10 per cent are unable to achieve control despite taking many drugs that relax the blood vessels and prevent water and salt retention.

The new treatment is being developed by Ardian Inc., a private company based in Mountain View, Calif., whose investors include medical device giant Medtronic Inc. It’s already available in Europe and costs about $12,000.

Dr. Murray Esler of Baker IDI Heart and Diabetes Institute in Melbourne, Australia, led a company-sponsored test of it in 106 people whose blood pressure top number averaged 178 despite taking an average of five drugs.

After six months, about 39 per cent of those treated had blood pressure below the 140 threshold for defining the condition.

However, Dr. Mariell Jessup, head of the heart failure centre at the University of Pennsylvania and chair of the heart conference, said “it seems too good to be true” that a procedure might cure high blood pressure.

Patients need to be followed for a long time to make sure the benefits last, she said.


Read more: http://www.cbc.ca/health/story/2010/11/17/blood-pressure-kidney-radio-waves.html?ref=rss#ixzz15ZNx9zLZ

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A warning about buying prescription drugs online

Health Canada is informing Canadians about the potential dangers of buying prescription drugs online from the following websites:  www.northdrugmart.comwww.northdrugstore.com and  www.pharmacyrxworld.com. Health Canada has identified prescription drugs for sale on these websites that have not been authorized for sale in Canada. These products contain references to brand names and resemble drugs that have been authorized for sale in Canada. As such, Health Canada suspects these products are counterfeit.

This may lead consumers to believe they are purchasing drugs that have been reviewed for safety, efficacy and quality by Health Canada. It is important to note that counterfeit drugs may contain no active or unsuitable ingredients, or dangerous additives. To this end, counterfeit drugs may pose a higher risk than other forms of unauthorized drugs.

Prescription products which have been approved for sale in other countries, or generic products purporting to be the equivalent of authorized products, must still be reviewed by Health Canada and must receive their own market authorization or product licence before they may be sold in Canada.

Canadians who have used any products purchased at these websites, or are concerned about their health, should consult with their healthcare practitioner.

According to the Ontario College of Pharmacists, these websites are not associated with a licensed pharmacy in Ontario. In addition, some products sold on these websites have not been authorized for sale by Health Canada. Should these websites continue to sell unauthorized health products to Canadians, Health Canada will take appropriate compliance actions.

Patients taking prescription drugs without being examined and monitored by a health care practitioner may not receive the appropriate treatment to maintain or protect their health. They may also put themselves at risk for drug interactions or harmful side effects.

Consumers should also be aware that there is no assurance that all claims made on the internet are reliable. Some internet sites falsely claim to be Canadian pharmacies and dispense foreign drugs that are unauthorized for sale in Canada.

Canadians with questions or complaints about drugs purchased over the Internet can call Health Canada’s toll-free line at 1-800-267-9675.

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Changes to new 2010 CPR & ECC Guidelines make it easier to save a life.

Heart and Stroke Foundation stresses one size doesn’t fit all when it comes to resuscitation.HSF survey finds that only 40% of Canadians trained in CPR would try to revive someone who has had a cardiac arrest

Ottawa, Oct. 18, 2010 – New emergency care guidelines simplify performing cardiopulmonary resuscitation (CPR) and highlight the need for high-quality CPR by addressing some of the barriers to performing CPR. The Heart and Stroke Foundation of Canada, co-author of the 2010 Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC), released the guidelines today.

The updated resuscitation guidelines have effectively mapped out a process of care based on the skill set of the rescuer, the situation and the resources available to respond. “In the past we limited ourselves by making the approach to resuscitation the same across all types of patients, all types of settings, and all types of rescuers,” says Dr. Andrew Travers, chair of the Heart and Stroke Foundation of Canada’s policy advisory committee on resuscitation and one of the expert co-authors of the 2010 guidelines. “We recognize that one size no longer fits all when it comes to CPR.”

The new guidelines stress early recognition, urging people to call 9-1-1 or their local emergency number if they ever find someone collapsed and unresponsive, and not to delay by “looking, listening and feeling” for breathing or pulse. They also recommend that instead of trying to remember how many compressions and how many breaths, bystanders doing CPR are urged simply to “push fast and push hard.”

“Many people hold back from doing CPR because they are afraid they may do it wrong or that they may hurt the person,” says Dr. Travers. “We want to make it clear that technique is less important than doing chest compressions quickly and firmly. Think of the ‘70s Bee Gees song Stayin’ Alive and that will give you an idea of how fast compressions should be done.”

The 2010 guidelines also note that to effectively move blood in the victim, compressions need to be fairly forceful. “Think about moving the heel of your hands up and down about two inches into the chest − or the height of your pinky finger,” says Dr. Travers. “We want people to know that they can make a difference, even just by taking these simple actions. But doing something – including making that 9-1-1 call immediately – is crucially important.”

The guidelines are reviewed every five years, and updated only when evidence is clear that changes will improve survival rates. The 2010 guidelines are based on input from 356 resuscitation experts from 29 countries, Heart and Stroke Foundation of Canada International Liaison Committee on Resuscitation (ILCOR) representatives and representatives of the American Heart Association and resuscitation councils of other countries. Hundreds of scientific evidence reviews were rigorously examined and resulted in the guidelines being updated in key areas.

The biggest update for healthcare providers and emergency medical services personnel involves changes to the order in which CPR skills are used: the first step should be chest compressions, followed by airway check then rescue breathing. This is a major change from previous guidelines, which recommended compression as the third step, after an airway check and rescue breathing had been performed. This shortens the time to the first compression, a significant factor in reducing brain and heart damage following cardiac arrest.

“We recognize that compressions are fundamental key building blocks – other things are important, but not as important as compression, and that is why we changed the order,” says Dr. Travers.

“These changes will help break down some of the barriers that keep people from doing CPR if they are faced with a cardiac emergency,” says Linda Piazza, director of health policy and research with the Heart and Stroke Foundation of Canada.

“Many Canadians want to help if they are ever faced with this type of situation, especially given the fact that four out of five cardiac arrests occur at home or in public places,” she notes. “The changes announced today make CPR easier to learn, easier to do and we believe will make Canadians more likely to step in and respond to a cardiac emergency.”

Only 40% of Canadians would try to revive victim of cardiac arrest
Currently, most victims of out-of-hospital sudden cardiac arrest do not receive any bystander CPR. To learn what barriers keep people from providing CPR, the Heart and Stroke Foundation recently surveyed Canadians on their willingness to act.  The national survey found that while 62% of Canadians said they had taken a CPR class, almost three-quarters reported that it was more than a year ago. And when asked what they would do if they saw someone having a cardiac arrest, just 40% said they would try to revive the person.

What’s stopping you?
Barriers that influence using CPR training to revive or resuscitate a person in cardiac arrest:

Nothing would prevent me from attempting to revive the person 40%
Lack of confidence in my skills & training 15%
Would prefer to wait for qualified help to arrive 8%
Unsafe/dangerous environment/personal safety 7%
Fear of catching a disease/something from the person 7%
Someone else might be already doing CPR 6%
Fear of legal liability/being sued 5%
Fear of failure/being unable to save the person 3%
Hazard/injury of person/victim 3%

Note: this is a subsample of respondents who have taken any training on how to perform CPR

Source: Environics National Omnibus Poll, September 2 to 10, 2010 re: HSFC Cardiopulmonary Resuscitation (CPR)

Overall, the odds of surviving a cardiac arrest are almost four times greater if someone performs CPR right away. When CPR is combined with an Automated External Defibrillator (AED), survival rates soar by up to 75%, according to the Heart and Stroke Foundation. Without CPR and defibrillation, fewer than 5% of people who have a cardiac arrest outside of a hospital survive.

“Although barriers cited include lack of confidence, fear of failure and potentially injuring the victim, the reality is that you can’t help if you don’t try. You can’t hurt the cardiac arrest victim if they don’t live to see another day, and without CPR, that is the likely outcome,” says Dr. Travers.

The Foundation recommends that all Canadians learn the life-saving skills of CPR and review this knowledge often. Learning and reviewing CPR skills has been made much easier with an at-home video kit, the Heart and Stroke CPR AnytimeTM for Family and Friends.TM The kit teaches the basic skills of CPR in as little as 22 minutes. People can review it at their leisure and share it with their families so that the skills can stay top-of-mind in case they are ever needed. Order your kit today at www.heartandstroke.ca/CPRanytime.

Read more at www.heartandstroke.ca/cprguidelines.

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Osteoporosis drugs linked to bone fractures

Health Canada is informing healthcare professionals and Canadians of an ongoing safety review of a group of drugs known as bisphosphonates and a possible increased risk of a rare but serious type of thigh bone fracture. Health Canada’s review will include consideration of the labelling change recently announced by the U.S. Food and Drug Administration .

There have been recent scientific reports suggesting a connection between the long-term use of bisphosphonates and an unusual type of thigh bone fracture known as an “atypical femur fracture,” including a recent report released by the American Society for Bone and Mineral Research.

The report observed that while these types of rare fractures may occur in both the general population and in patients treated with a bisphosphonate, the risk appears potentially higher in those using a bisphosphonate, particularly after several years of therapy.

Bisphosphonates are prescription drugs used to treat osteoporosis in men and post-menopausal women.  They can also be used to prevent osteoporosis in post-menopausal women and in patients taking glucocorticoids. Brand names of medications in this class include Aclasta (zoledronic acid), Actonel (risedronate), Didrocal (etidronate), and Fosamax (alendronate). All but Aclasta are also available in generic forms in Canada. Osteoporosis is a loss of bone density often associated with aging that can cause painful fractures, disability and deformity. Bisphosphonates have a long history of effective use in osteoporosis treatment and prevention.

At this time, based on the scientific evidence available, Health Canada considers that the benefits of bisphosphonate outweigh the risks when used as directed in the Canadian Product Monographs. Should Health Canada’s review identify new safety information, Health Canada will take appropriate action and inform health professionals and Canadians as necessary.

Signs of a possible fracture of the thigh bone include new or unusual pain in the groin, hip, or thigh area. Patients taking a bisphosphonate who experience this type of pain are advised to consult their healthcare professional. Patients with questions or concerns about the bisphosphonate they are taking should talk to a healthcare professional.

Healthcare professionals and patients can obtain detailed product information about bisphosphonates in the Canadian Product Monographs.

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Bisphenol A (BPA) declared toxic in Canada

The Government of Canada  has declared Bisphenol A, or BPA, a toxic substance. BPA is commonly found in the plastics used to coat the inside to cans, and other soft plastics. More recently it has turned up in the coatings used on cash register receipts used by most retailers.

What this toxic declaration means is that the Government of Canada will most likely begin setting up some kind of regulatory or measurement framework to determine to what extent the product is being used in the country with the goal of eventually banning it completely. How long this will take is anyone’s guess.

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Health Canada pulls Meridia® from the Canadian market

OTTAWA – Health Canada is informing healthcare practitioners and Canadians that Abbott Laboratories is voluntarily withdrawing the prescription weight-loss drug sibutramine, which is marketed under the brand name Meridia®, from the Canadian market.

Abbott’s decision, in collaboration with Health Canada, comes in light of data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, a large study that suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients with heart problems. The purpose of the study was to determine a link between long-term sibutramine use and the risk of cardiovascular events in patients with pre-existing cardiovascular disease, or who were at risk of heart-related adverse events. Nearly 10,000 overweight and obese subjects aged 55 years and older were enrolled in the trial for up to six years.

It’s important to note that since sibutramine was first authorized for sale in December 2000, it has not been recommended for use in patients with existing cardiovascular disease. Health Canada has communicated in the past on the risk of cardiovascular events in patients with heart problems and on the importance of prescribing sibutramine as directed in the Canadian Product Monograph. Most recently, in October 2007, Health Canada published an article in the Canadian Adverse Reaction Newsletter on the subject.

Despite these previous risk mitigation measures, there continues to be concern of an increased risk of heart-related adverse events, particularly as people at risk of cardiovascular disease may not have symptoms. In light of this concern, and the accumulating scientific evidence on the safety and efficacy of Meridia®, it has been determined that the benefits no longer outweigh the risks for this drug.

Sibutramine is also authorized in Canada in generic forms. Health Canada will take appropriate action with respect to all sibutramine-containing products on the market.

Patients currently taking Meridia® (sibutramine) should contact their healthcare practitioner regarding potential alternatives. Pharmacists and patients with questions regarding their current stock of Meridia® should contact Abbott Laboratories directly at 1-800-567-2226.

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Harness the power of herbs to make your own male supplements.

I began experimenting with herbals to create a male energy supplement to take in addition to my daily vitamin when I began weight training again. The goal was to create a supplement that had no side effects and yet would be beneficial to male hormone levels while giving me an increased energy level for workouts.

If you look at a lot of the male herbals out there you will find they contain only a handful of common ingredients, which are easy to get in Canada. If you don’t live near a good herbalist you can get these herbs by mail order, and I will provide a recommended source at the end of this article.

Buying pre-made, patent herbal supplements is expensive. Supplements you compound yourself will not only save you a lot of money, but be superior to store bought in that you can control the source and quality of the ingredients.

When you buy your herbal ingredients in bulk, select “wild crafted” or “organic” powdered herbs and buy from well respected shops or online outlets. Personally, I would rather make my own than buy a pre-made male herbal supplement made from unknown sources. Some of these store bought supplements in the male health section go for as much as $80 for a bottle of 100 capsules!

You can make your own capsules easily enough. Here’s how.

First, you will need a capsule maker. The one I use is the 00 size Cap-M-Quick, which lets you make 24 capsules at a time. Next, you need empty gelatin capsules. I suggest combing ebay for sellers and buy 00 vegetable caps in bulk. Or see the link below. Don’t buy the standard gelatin capsules because they tend to absorb moisture from the air when stored and might not fit in your capsule machine after a while. I bought a few thousand vegetable capsules on ebay some years ago and I am still using them. A good investment.


As for the herbal combo, here is my secret recipe:

4 oz muira puama powder
4 oz tribulus root powder
4 oz epimedium grandiflorum powder
4 oz damiana leaf powder

Pour the ingredients into a large zip lock bag, zip closed, shake. Voilà, you’ve made your raw male supplement. Now all you have to do is follow the capsule maker instructions and you will have at least 1500 to 2000 capsules of a premium quality male herbal supplement. Bottle and store in a cool dark dry place.

For dosage, I take 4 caps in the morning and four in the evening.

My Canadian bulk herb supplier is Herbie’s Herbs in Toronto:
556 Queen Street West
Toronto, ON M5V 2B5
(416) 504-5755
herbies-herbs.com

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