Showing posts with label Health Canada. Show all posts
Showing posts with label Health Canada. Show all posts

Health Canada : Consumer Product Update: Health Canada Warns of Fire Risk to Oxygen Therapy Patients from Electronic Cigarettes and Other Electrical Devices


Health Canada has been notified of an incident in the Province of Quebec resulting in an injury to a consumer from a fire associated with the use of an electronic cigarette in the presence of an oxygen source. 
According to the information currently available, the injured individual was undergoing oxygen therapy at the time of the incident. 
Health Canada is aware of similar incidents reported in other countries. Health Canada is working with the relevant authorities to further evaluate the incident in the Province of Quebec. 

For more information, please CLICK HERE

Health Canada reviewing possible safety concerns with certain long-term antiplatelet (blood thinner) therapy; Benefits of treatment still outweigh potential risks

Issue

Health Canada is aware of and will be reviewing new evidence on the safety of long-term use of the prescription blood-thinners clopidogrel (Plavix) and prasugrel (Effient).
Clopidogrel and prasugrel reduce the risk of blood clots in patients who have had a heart attack, stroke or related blood clotting diseases. Dual antiplatelet therapy is the use of a blood thinner in combination with ASA (acetylsalicylic acid or Aspirin). It is commonly used following coronary stent implantation to reduce the risk of blood clots. Coronary stents are tiny tubes that are implanted in narrow or weak heart arteries to maintain blood flow to the heart.
It is important to note that Health Canada has not reached new conclusions or made recommendations regarding clopidogrel or prasugrel safety at this time. The benefits of clopidogrel and prasugrel in protecting against blood clots continue to outweigh their risks when used as directed.
The new evidence is from the Dual Antiplatelet Therapy (DAPT) Study, a large-scale, multi-national clinical trial that evaluated 12 versus 30 months of clopidogrel or prasugrel use with ASA, known as dual antiplatelet therapy. The study looked at how these drugs can prevent blood clots in patients with coronary stents. Its findings were recently published in the New England Journal of Medicine.
Health Canada is evaluating preliminary information from the study, which found that 30 months of dual antiplatelet therapy was beneficial in reducing blood clots and heart attacks relative to 12 months, but saw an increase in deaths due to non-cardiovascular causes in the 30-month group versus the 12-month group.
Health Canada will continue to evaluate the available information from this trial along with other information, and is aware of the recent communication issued by the U.S. Food and Drug Administration. Health Canada will take appropriate action based on the results of the review once it is complete, including communicating new safety information to health professionals and Canadians as necessary.
Patients with questions or concerns about their dual antiplatelet therapy should talk to their doctor.  Patients should not stop using clopidogrel and prasugrel unless on the advice of their healthcare professional. Stopping treatment may increase the risk of blood clots, which can be fatal.

Health Canada Recall Alert - Dangers of Swallowing Small Magnetic Parts from Mega Brands Magnetix Magnetic Building Sets

Issue

Health Canada is alerting the public to the danger to children of all ages posed by toys with small, powerful magnets or certain toys with small powerful magnetic parts. When more than one powerful magnet is swallowed in a short period of time, the magnets can attract one another while moving through the intestines. This can cause the intestines to twist, creating blockages or tearing of the intestinal walls. The results of swallowing small powerful magnets can be very serious and life-threatening. Swallowing incidents have often resulted in considerable damage to the gastrointestinal tissues and required emergency surgical treatment. For survivors, there can be serious lifelong health problems.
Health Canada recently received an incident report involving a three year old child who swallowed two magnetic parts (2.7 cm long rods) from a Mega Brands Magnetix Magnetic Building Set. The child received swift medical attention and sustained no injury.

Products affected:

Mega Brands Magnetix Magnetic Building Sets, sold in Canada from 2006 to 2009.
887,000 units from over 100 different Magnetix sets were sold in Canada. They contained up to 350 plastic building pieces in an assortment of colours (primary) and finishes (metallic, translucent and glow in the dark). The building pieces included 2.54 cm triangles, cylinder rods, flexors and curves, as well as 1.25 cm diameter steel balls.
Due to numerous serious injuries requiring emergency medical treatment, and one fatality in the United States in 2005, Magnetix Magnetic Building Sets sold before April 2006 were recalled in Canada in 2007. For these toys the small, powerful magnets were prone to separate from their plastic parts. Both younger and older children were involved in swallowing incidents. Mega Brands redesigned their Magnetix magnetic building parts so that the small, powerful magnets were more securely attached. Building sets with these modified parts were sold in Canada from April 2006 to March 2009. Even though the small magnets were no longer detaching during play, many of the magnetic building parts in these sets were small enough to be swallowed by a child, as was the case in the recent incident where two rods were swallowed.
At the time these products were originally sold, they met the relevant requirements for safety; however, those requirements have evolved. Today, certain toys with powerful magnets are considered a serious danger to children of all ages. These toys have powerful magnetic parts that are small enough to be swallowed or have small, powerful magnets that separate from parts.

What you should do

Consumers should immediately and safely discard all Mega Brands Magnetix Magnetic Building Sets. They are also reminded to discard any older-style Magnetix magnetic toys that were recalled in 2007. The toys should be disposed of in normal household garbage in such a way that they cannot be used or re-sold. Please note that the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

Health Canada Product Withdrawal : Gra-MaxX Gold: Seized from "ShopForYou", Vancouver, B.C. due to serious safety risks

Issue
An unauthorized health product, Gra-MaxX Gold, was seized by Health Canada as it contains an undeclared drug: N-Ethyl Tadalafil. The product is used to treat erectile dysfunction. The product was tested by Health Canada and removed from sale from ShopForYou, Robson Street, Vancouver, B.C. This product may pose serious risks to the health of Canadians, especially individuals with heart problems.

Products affected

Gra-MaxX Gold.

What you should do

  • Consult with your doctor if you have used this product.
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
  • Report any adverse events to Health Canada.

    Who is affected

  • Consumers who have used or purchased Gra-MaxX Gold.

    Background

    Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its analogs should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure.
    Individuals with heart problems including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they engage in sexual activity, especially if they use tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.
    Caffeine was also found in the product and was not listed on the product label. Caffeine may pose health risks to people sensitive to its effects.
     

Health Canada Harper Government Announces Passage of Vanessa's Law - Modernized Laws for Drugs and Medical Devices Mark a New Era in Canadian Patient Safety...

The Honourable Rona Ambrose, Minister of Health, joined by Member of Parliament for Oakville Terence Young, today celebrated a major milestone for patient safety in Canada - the passage of new legislation known as Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act). 
Delivering on a promise in the 2013 Speech from the Throne, the Act will protect Canadians from unsafe medicine by enabling the Government to:
  • Recall unsafe products;
  • Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
  • Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
  • Compel drug companies to revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children;
  • Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children;
  • Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions;
  • Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative;
  • Require information about authorized Canadian clinical trials to be posted on a public registry;
  • Better define confidential business information and disclose such information about a product if it may pose a serious risk to Canadians.
These new transparency measures build on the progress Health Canada has already achieved through its Regulatory Transparency and Openness Framework. The Framework commits Health Canada to a set of concrete initiatives that will make easy-to-understand regulatory health and safety information more available to Canadians. 

Quick Facts
  • Vanessa's Law is named after Member of Parliament Terence Young’s daughter Vanessa, who died of a heart attack while on a prescription drug that later was deemed not safe and removed from the market.
  • The Bill received all-party support in the House of Commons in light of its important new safety provisions that will benefit Canadians.
  • The Protecting Canadians from Unsafe Drugs Act introduces the most profound and important changes to the Food and Drugs Act that have been made since it was introduced more than 50 years ago.
Quotes

“Today is an historic day for patient safety in Canada. As Minister of Health, nothing is more important to me than the safety of Canadians and their families. Through Vanessa’s Law, Canadians will be better informed about medications they are prescribed, and our Government will be empowered to recall unsafe products from the market. I am confident that Canadians will be better protected and lives will be saved as a result of these changes.” Rona Ambrose, Minister of Health

For more details CLICK HERE

Health Canada restrict import of products from three Micro Labs facilities in India...

Health Canada took action today to restrict the import of health products from three Micro Labs facilities in India (Bangalore, Goa and Hosur) because of data integrity concerns identified in recent inspections by international partners.
Health Canada has compiled a list of products affected by the import restrictions. The list will be updated as new information becomes available.
The licences of companies that import products from these three facilities will be amended with terms and conditions to require independent third-party testing prior to the release of any products determined to be medically necessary onto the Canadian market. Products from these three sites that are not on the medically necessary list will not be allowed to beimported or released on to the Canadian market until Health Canada is satisfied that the data integrity issues at the plants have been addressed.
Independent testing against approved Canadian specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.
Health Canada continues to gather information about the situation at these sites from trusted international partners, including the U.S Food and Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization. Based on a review of this information, the Department has significant concerns with the manner in which data are collected and reported, raising uncertainty about the quality and safety of products from these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMPs), it is taking this additional precautionary step to keep these products off the Canadian market.

Health Canada : Government advances measures to make cosmetic contact lenses safer...

Today, in a move widely supported by optometrists, ophthalmologists and opticians, the Honourable Rona Ambrose, Minister of Health, announced that Health Canada will be consulting on new guidance for industry that will lead to non-corrective or ‘cosmetic’ contact lenses being regulated as medical devices.
‘Cosmetic’ contact lenses (also called decorative lenses) are used to change the colour or appearance of the eyes and are typically sold by costume and cosmetic retailers. Until now, these types of lenses have been regulated as consumer products. However the risks of decorative lenses are identical to the risks of corrective lenses and adverse events causing harm and even permanent damage to the eyes are not uncommon.
As medical devices, cosmetic contact lenses would be subject to specific requirements for licensing, manufacturing, labeling, and instructions to improve their safety before they go on the market. The proposed changes to the Medical Device Regulations are being published in Canada Gazette I on October 18 to begin consultations. In addition, new guidance documents and new application forms will be posted on the Health Canada website for a 75-day comment period.
Quick Facts
  • Contact lenses are not suitable for everyone. Some people are more at risk of adverse reactions.
  • Smokers who use contact lenses are eight times more likely to develop corneal ulcers than non-smokers, no matter which type of contact lenses they wear.
  • According to a recent French study, the risk of severe corneal infection related to contact lens wear for cosmetic purposes is 12.5 times higher than with corrective contact lenses.
Quotes
“Improving patient safety is a priority for our Government. These new measures will help to make cosmetic contact lenses safer for Canadians, protecting our eyes and vision from needless harm.” Rona Ambrose Minister of Health
“I’m very pleased by the actions taken by the Government, in accordance with Private Members Bill C-313, to ensure that moving forward Cosmetic contact lenses are made subject to the same licensing, manufacturing and labeling as has long been required for regular, prescription contact lenses. I believe these consumer protection measures announced today by the Government of Canada go a long way towards addressing the concerns expressed by Canadian eye care professionals from coast to coast to coast. “ Pat Davidson Member of Parliament: Sarnia-Lambton
“The Canadian Association of Optometrists and other vision health professionals are concerned about the great risk of harm to the eye and vision caused by the use of non-corrective contact lenses – primarily due to improper use and supervision. We are very happy to see these proposed new regulations moving forward.” Dr. Paul Geneau, President Canadian Association of Optometrists

Health Canada seizes dangerous health products from online retailer...

Health Canada is warning Canadians of the serious risks to health associated with use of the unauthorized drug product Miracle Mineral Solution (MMS), which was sold as a treatment for serious diseases such as cancer through the website www.buymms.biz. MMS contains sodium chlorite, which is a chemical used mainly as a textile bleaching agent and disinfectant and may pose serious risks to health if ingested. 
An alternate format of MMS, labelled as CDS, is also available for sale on the website and would pose a similar risk.

Products affected

1. MMS (28% sodium chlorite and 50% citric acid)
2. CDS (chlorine dioxide 8000 ppm)

What you should do

  • Stop using MMS products immediately.
  • Consult their doctor or pharmacist if they have used or are using MMS products distributed by www.buymms.biz.
  • Report any adverse events to Health Canada.

Who is affected

Canadians who have purchased Miracle Mineral Solution (MMS) products on the Internet from www.buymms.biz or any of its previously used company names: www.themmsstore.com, www.miraclemineralsupplement.com, and www.mms1.com.

Background

No drug products containing sodium chlorite have been approved by Health Canada for consumption by humans. Sodium chlorite is authorized in Canada for use as a germicide by veterinarians and as a hard surface disinfectant. Sodium chlorite is commonly used for bleaching textiles, pulp and paper, as well as in the generation of disinfectant for water treatment.

For more information:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Health Canada : Voluntary Recall Alert Update : Nitroglycerine Spray Recall by Mylan Pharmaceuticals...

Health Canada is advising Canadians that Mylan Pharmaceuticals ULC has begun a voluntary recall of certain lots of its Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose to the retail level. The recall is a result of the product potentially missing the "dip tube," which is part of the pump component. A missing "dip tube" could pose a problem with the delivery of nitroglycerin to the patient.

Health Canada had previously informed Canadians about this issue, but the recall was initially delayed due to the possibility of creating a shortage of this medically necessary heart drug on the Canadian market.

Health Canada would also like to inform Canadians that Mylan Pharmaceuticals ULC is now releasing product from a different lot that had been set aside and now verified to have a "dip tube" by the company. Consumers should verify that there is a checkmark sticker on the product's canister closure and carton, which demonstrates that it has the "dip tube".
In order to help ensure ongoing supply of the product, the company is advising consumers to continue using their current canister and only refill their prescription once one-third of their spray (70-75 doses) has been used.

Consumers should consult their pharmacist or healthcare practitioner if they have any concerns regarding the use of this product and report any adverse events to Health Canada.

Health Canada bans import of APIs and Finished Products from 3 sites in India...

Health Canada took action today to stop the import of health products from the following sites in India:
  • Apotex Pharmachem India Pvt Ltd (APIPL)
  • Apotex Research Private Limited (ARPL)
  • IPCA Laboratories
The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.
Health Canada has compiled an initial list of products affected by the Import ban.

CLICK HERE TO VIEW COMPLETE LIST OF PRODUCTS AFFECTED BY IMPORT BAN


The list will be updated periodically.

Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.

Health Canada continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. Based on recent information, the Department has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMP), it is taking this additional precautionary step to keep these products off the Canadian market.

For more details CLICK HERE

Health Canada : Mylan Pharmaceuticals recalling nitroglycerin spray due to defective pump...

Mylan Pharmaceuticals ULC Canada, in consultation with Health Canada, is voluntarily recalling all lots of its Mylan-Nitro Spray 0.4 mg/metered dose due to the product missing the "dip tube," which is part of the pump component.
A missing "dip tube" could pose a potential problem with the delivery of nitroglycerin to the patient. This defect may lead patients to believe they are receiving the nitroglycerin, when in fact they are unable to access it. Not receiving nitroglycerin could place them at risk for either a delay in treatment for their angina or of suffering a heart attack.

Products affected

  1. Mylan-Nitro Spray 0.4 mg/metered dose (Lots: 2L734, 2L731, 3E830, 3E828, 3F834, 3F837, 3K873, 3K877B, 4B948, and 4B949)

What you should do

  • Return the product to the pharmacist and get a replacement.
  • Speak to your healthcare provider if you have any concerns regarding the use of this product.
  • Report any adverse events to Health Canada.

Who is affected

Canadians who are using the Mylan-Nitro Spray (0.4 mg/metered). The company has indicated that it has not received reports of any adverse events associated with the defective product.
For more details CLICK HERE

Health Canada : Baxter recalls certain lots of hemodialysis solutions due to particulate matter found in the product...

Baxter Corporation, in collaboration with Health Canada, is voluntarily recalling specific lots of two Acid Concentrate hemodialysis solutions (see below) due to particulate matter found in the product. Particulate matter in the product may cause inadequate dialysis and may result in serious injury such as allergic reactions or blockage of small blood vessels if it enters into a patient's bloodstream.The affected products were distributed to hospital and home settings between January 31, 2014 and July 18, 2014. These products are used in home hemodialysis patients. Those who administer these products in home-care settings should check the lot numbers before administration.

Products Affected
  1. Acid Concentrate 45X (45 K, 67.5 Ca) (DIN 02158256) Lot No. W4D17D1
  2. Acid Concentrate 45X (45 K, 45.0 Ca) (DIN 00860611) Lot No. W4A24D1

What you should do

  • Immediately examine your stock to determine whether you have any of the affected product lots. If any of these are found, speak to your healthcare provider immediately regarding replacement product.
  • Contact Baxter Corporation Customer Care at 1-888-719-9955 for instructions on how to return the recalled product.
  • Report any adverse events to Health Canada.

Who is affected

Canadians who have used the affected lots of either of these two products. The company has indicated that it has not received reports of any adverse events associated with the particulate matter.

Background

These products are used as a form of dialysis (hemodialysis) that removes waste products from the blood by passing them out of the body through a filtering system and returning them, cleaned, to the body.

For more details CLICK HERE

Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issues...

Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the U.S. Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the affected products.

Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs). The Department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products.

To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.

The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments. This process will likely take a few weeks to complete given the complexity of efforts. At this time, we do not expect that there will be an immediate impact on the availability of these products. The Department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.

Health Canada has requested that the voluntary quarantine continue until the Department is satisfied that adequate measures are in place to confirm the quality of the products from these facilities and protect the health and safety of Canadians.

For Detailed Information CLICK HERE

Health Canada: Foreign Product Alerts


Health Canada is advising Canadians not to use these foreign health products as they may pose a health risk. These products have been found by regulators in other countries to contain drug ingredients that are not declared on the product labels. Prescription drugs should only be taken under the supervision of a healthcare professional. 

These products are not authorized for sale in Canada and have not been found on the Canadian market, but they may have been brought into the country by travellers or purchased over the Internet:  For details on alerts click on below links...

Health Canada: Home Canning - Prepare it Safely..!!!

Issue

Home canning is a popular and safe way to preserve food for later use. Jams, pickles, soups, sauces, meat and seafood are frequently canned in glass jars. If home canned foods are not properly prepared, they can cause serious illness such as botulism. Botulism is caused by the toxin of bacterium - called Clostridium botulinum -that affects the nervous system and can cause paralysis.
It is estimated there are approximately 4 million cases of food-related illnesses of all types in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.


What you should do

The toxin that causes botulism is colourless, odourless, tasteless and invisible to the naked eye. You can prevent the toxin from forming in canned foods by following these tips:
  • Wash your hands using hot soapy water, and clean and sanitize all work surfaces, utensils and equipment. Keep them clean during all stages of the canning process. For a sanitizer, you can prepare a bleach solution by mixing 5 ml (1 tsp) of domestic bleach with 750 ml (3 cups) of water in a spray bottle. Spray surfaces and utensils, let it sit a minute and rinse with drinking water.
  • Use a pressure canner when canning low acid foods. A pressure canner is a large pressure cooker optimized for canning. Strictly follow the manufacturer's instructions for canning foods considered to be low-acid, such as seafood, meats, vegetables and sauces. These low-acid foods must be processed in a pressure canner to destroy any Clostridium botulinum spores that might be present.
  • Foods such as fruit, pickles, jams, jellies, and marmalades will not support the growth of Clostridium botulinum due to their high acidity or high sugar content and can be safely processed in a boiling water canner. Make sure to follow the recipe. You cannot substitute sugar with pectin, as this will affect food safety. Pectin is often used to thicken foods such as jelly and jam.
  • Tomatoes are a borderline high-acid food and require an acid, such as lemon juice, citric acid or vinegar, to be added for safer canning.
  • Canning foods in their fresh state without added liquid is often not safe. The container should be topped up sufficiently with suitable liquid, such as syrup, sauce, brine or acidifying agent. When following tested recipes, do not substitute ingredients, change ingredient amounts or change the jar size that is in the recipe. Any modifications could lead to bacteria remaining in the food, and affect the safety.
  • Always follow the recommended recipes and processes along with the recommended temperature, time and pressure.
  • Each jar lid should be firmly sealed and concave (curved slightly inwards after cooling to room temperature). Before using stored foods - check that nothing has leaked from the jar, there are no unnatural odours and no liquid should spurt out when the jar is opened.
  • Clearly label your home-canned food, including the date it was canned. For best quality, use within one year from the date it was made.
  • Be sure to store your home-canned food in a cool, dry place. Once the container has been opened, refrigerate leftovers immediately.

Last words of wisdom

If you are buying or are given home canned products, ask about their preparation to help you to determine whether the proper safety steps were followed.

"Always remember: never eat canned foods if you suspect the item has been tampered with, if the closure/seal has been broken, if the ends of the metal can or if the jar lid are swollen or leaking, or if the label is stained."

When in doubt, throw it out!