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SAFETY BULLETINS


April 14, 2014 Medical Device Alert: Amplatzer Septal Occluder may cause risk of erosion.


St. Jude Medical Inc., in collaboration with Health Canada, has issued a communication regarding a rare but serious risk of erosion associated with the AMPLATZER Septal Occluder (ASO). The ASO is a medical device implant that is used in adults and children to close an opening (hole) in the wall (also known as septum) of the heart.

St. Jude Medical has updated the label for the ASO with respect to the adverse event of erosion. Erosion is a rare but potential life threatening event which may be caused by the ASO rubbing against the wall of the heart or surrounding structures. Symptoms of possible erosion may include shortness of breath, chest pain, fainting, and/or rapid or irregular heart beat. Any patient with an ASO who experiences any of the symptoms of erosion should immediately call his or her heart specialist, or go to the nearest emergency room. Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Any case of erosion or other serious or unexpected adverse incidents with an ASO should be reported.


Mar 26, 2014: Drug Alert: Immunosuppressants Imuran or Purinethol Associated with a Type of Blood Cancer


Health Canada is informing Canadians that certain immunosuppressant medications are linked to increased risk of developing a type of blood cancer called hepatosplenic T-cell lymphoma.

IMURAN® is a drug used to treat adult rheumatoid arthritis and help prevent kidney transplant rejection. PURINETHOL® is a drug approved to treat cancer (leukemias). IMURAN® and PURINETHOL® are not approved in Canada for the treatment of Inflammatory Bowel Disease (IBD) such as ulcerative colitis, but are sometimes used for such as an off-label use.

Hepatosplenic T-cell lymphoma (HSTCL) is a rare1, aggressive and often fatal cancer.
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp Cases of Hepatosplenic T-cell Lymphoma (including deaths) have been reported in IBD patients treated with IMURAN® (azathioprine) or PURINETHOL® (mercaptopurine).
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp IMURAN® and PURINETHOL® labels have been updated to include the associated risk of HSTCL.
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp Patients should discuss the current information regarding risks and benefits of these treatments with their doctors.

Cases of HSTCL (including deaths) have been reported with the use of IMURAN® and PURINETHOL® in Canada and internationally mostly in patients where it is used to treat inflammatory bowel disease (IBD). A total of 238 cases of HSTCL have been reported worldwide1, indicating this cancer is rare.

Triton Pharma Inc. and Teva Canada Ltd. have sent a letter to healthcare professionals informing them of this safety information. This letter can be obtained on the Canadian website of Triton Pharma Inc. and Teva Canada Ltd. or on the Healthy Canadians Web site. If you have questions regarding your IMURAN® or PURINETHOL® prescriptions, please contact your doctor.

The complete prescribing and adverse event information for IMURAN® can be found in the approved Product Monograph2 which is available on the Health Canada website and on the Triton Pharma Inc. website.

The complete prescribing and adverse event information for PURINETHOL® can be found in the approved Product Monograph3 which is available on the Health Canada website and on the Teva Canada Ltd. website.


March 21, 2014: Food Alerts: The Meat Shoppe Inc recalling The Meat Shoppe brand shredded cheese products due to possible Listeria contamination.


Consumers are being warned not to consume The Meat Shoppe brand shredded cheese products as they may be contaminated with Listeria. Affected products include:

The Meat Shoppe: Shredded Cheddar Cheese; Variable sizes; Packed on dates from 2014JA08 up to and including 2014MR03

The Meat Shoppe: Shredded Mozza Cheese; Variable sizes; Packed on dates from 2014JA08 up to and including 2014MR03.

If you purchased either of these products you are advised to check if you have the recalled product and either throw it out or return it to the store where you purchased it from. The item may not look or smell foul but can still make you sick. Those especially at risk are pregnant women and their unborn child as the infection can lead to premature delivery, illness of the newborn and even stillbirth. Symptoms of Listeriosis may include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. As of the date above there have been no reported illnesses associated with the consumption of these products. The recall was triggered by the company.


March 20, 2014: Kirkland Signature brand Grilled Chicken Breast Strips recalled due to possible Listeria contamination.


Consumers are being warned not to consume Kirkland Signature Grilled Chicken Breast Strips as it may be contaminated with Listeria. Affected product includes:

Kirkland Signature: Grilled Chicken Breast Strips; 2x500g; Best Before of: APR13-APR26 inclusive.

If you recently purchased this product you are advised check if you have the recalled products and to either throw it out or return it to the store where you purchased it from. The item may not look or smell foul but can still make you sick. Those especially at risk are pregnant women and their unborn child as the infection can lead to premature delivery, illness of the newborn and even stillbirth. Symptoms of Listeriosis may include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. As of the date above there have been no reported illnesses associated with the consumption of these products. As of the date above there have been no reported illnesses associated with the consumption of these products. This recall was triggered by the Canadian Food Inspection Agency test results.


March 20, 2014: Undeclared almonds, pecans, gluten and sulphites in The Chocolate Factory brand Our Ever Famous Assorted Chocolates.


Affected products include: The Chocolate Factory: Our Ever Famous Assorted Chocolates 400g.


March 11, 2014: Medical Device Alert: Abbott FreeStyle glucose test strips may produce inaccurate results with certain devices


Health Canada has issued an advisory to those using Abbot FreeStyle glucose test strips that there is a possibility for lower than actual blood sugar readings when used with some glucose meters. False readings could mislead users in treatment/diet decisions that could lead to hyperglycemia (elevated blood sugar levels). The meters are: Abbott Diabetes Care’s FreeStyle Blood Glucose Meter, FreeStyle MiniBlood Glucose Meter, and Insulet’s OmniPod Insulin Management System. Those with affected FreeStyle meters are advised to contact Abbott Diabetes Care at 1-877-576-9368 whereas those with Insulet Omni Pod Insulin Management System should contact Abbott Diabetes Care at 1-877-607-6364


Feb 27, 2014: Natural Health Product Alert: Herbal detox and laxative products Formule L1 and Detox Spring Fall recalled


Health Canada is informing Canadians that Les Importations Herbasanté Inc. is voluntarily recalling Formule L1 and Detox Spring-Fall because the labels are missing important risk statements, including the contraindications and warnings associated with the use of these products. In addition, the two products are being sold in a single package and pose an increased risk to health when used together. To date, Health Canada has not received any reports of adverse drug reactions related to the use of these products.

Products affected:
Formule L1, sold co-packaged with Detox Spring Fall (24 Detox ampoules + 36 Formule L1 capsules)

Background
Formule L1 is sold as a herbal laxative and Detox Spring-Fall as a diuretic (water pill). These two products are being sold in a single package. Detox Spring-Fall should not be used in combination with Formule L1, as Formule L1contains a laxative. The use of these products together may cause severe dehydration.

The complete list of cautions, warnings and contraindications associated with these products is listed below:

Formule L1 Risk Information:

Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner if raised intraocular pressure or edema occurs. Consult a health care practitioner prior to use if you have a kidney disorder or are taking prescription medication (e.g. cardiac glycosides or antiarrhythmic medications); if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever; if you have gallstones. Reduce dose or discontinue use if you experience abdominal pain, cramps, spasms, and/or diarrhea. Consult a health care practitioner prior to use if you are taking thiazide diuretics, corticosteroids, licorice root or other medications or health products that may aggravate electrolyte imbalance.

Contraindications
Do not take if you are pregnant or breastfeeding. Do not take if you are using anticoagulant or antiplatelet medication; if you are allergic to plants of the Asterceae/Compositae/Daisy family; if you have a bile duct obstruction. Do not use if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes, hemorrhoids or diarrhea.

Known Adverse Reactions
Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

Detox Spring-Fall Risk Information:

Cautions and Warnings
Consult a health care practitioner before using if you are pregnant or nursing, if you suffer from diabetes or have liver problems. Consult a health care practitioner if symptoms persist or worsen. Discontinue use and consult a health care practitioner immediately if you experience dizziness, vertigo, mental confusion, muscular weakness or pain, an irregular heart beat and/or difficulty breathing.

Contraindications
Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family. Do not use if you have liver or gallbladder problems, or an intestinal obstruction. Discontinue use if you experience symptoms of liver problems. Do not use if you suffer from stomach irritation or acute stomach inflammation, or a gastric or duodenal ulcer. Do not use if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications or health products that may aggravate electrolyte imbalance. Do not use if you have hypokalemia, high blood pressure, or cardiovascular or kidney problems. Do not use if you are dehydrated. Do not use if you suffer from heart, kidney or liver problems, high or low blood pressure, or oedema (swelling of hands, face or feet) or if you take products that contain diuretics.

Known Adverse Reactions
Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use. Some people may experience headaches.

What you should do:
Consumers should be aware of the risks associated with these products. The complete list of cautions, warnings and contraindications associated with these products can be found in the Background section of this advisory. If you have used these products and are concerned about your health, please consult your healthcare practitioner. Consumers are also encouraged to return the products to the place of purchase or call Les Importations Herbasanté Inc. at 1-800-446-4242.


Feb 18, 2014: Foreign Product Alert: Li Long Mei Guo Mo Bang, and Ginseng Tu chong Wan Lin Heong


These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Affected products
1. Li Long Mei Guo Mo Bang
2. Ginseng Tu chong Wan Lin Heong

Li Long Mei Guo Mo Bang
This product is promoted for sexual enhancement. The Singapore Health Sciences Authority warned consumers not to use this product after it was found to contain sildenafil, a drug ingredient that was not declared on the product label. Sildenafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a healthcare professional. The place of origin is unknown.

Side effects
Sildenafil should not 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 are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Ginseng Tu chong Wan Lin Heong
This product is promoted for treatment of arthritis and joint pain. The Singapore Health Sciences Authority warned consumers not to use this product after it was found to contain dexamethasone, a drug ingredient that was not declared on the product label. Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. It should only be taken under the supervision of a healthcare professional. The place of origin is unknown.

Side effects
Side effects associated with dexamethasone include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Consult with your healthcare professional prior to stopping use, as sudden discontinuation of dexamethasone may cause symptoms of withdrawal.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find either of the products listed above in the Canadian marketplace.

Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.

Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of January 31, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.


Feb 7, 2014: Foreign Product Alert: Plexus Slim Accelerator capsules, and Plexus Slim Accelerator 3 Day Trial pack


These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Affected products
1. Plexus Slim Accelerator capsules
2. Plexus Slim Accelerator 3 Day Trial pack

Plexus Slim Accelerator capsules, and Plexus Slim Accelerator 3 Day Trial packbr> These products are promoted for weight loss. The Australia Therapeutic Goods Administration (TGA) warned consumers not to use these products as they were found to contain 1,3-dimethylamylamine (DMAA), a drug that is not approved for sale in Canada.

Health Canada received one Canadian report of a serious adverse reaction suspected to be associated with a "Plexus Slim Accelerator" product. Due to limited information at this time, Health Canada is unable to determine whether the product reported is the same as the product that is the subject of the TGA alert, or what role, if any, the product may have played in the adverse reaction. It is not known where the product was purchased. Health Canada is currently following up on this report.

Side effects associated with DMAA include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find either of the products listed above in the Canadian marketplace. Canadians who have these products are advised not to use them, and should consult with a health care professional if they have concerns about their health related to the use of these products.

Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of December 31, 2013, Health Canada has received one report of an adverse reaction suspected to be associated with the use of these products.


Jan 3, 2014: Sublinox (zolpidem tartrate) Sleep Medication- Adjusted Dosage Recommendations


Health Canada has endorsed important changes in safety information for the drug Sublinox (zolpidem tartrate), a commonly prescribed sleep medication. There are new dosage recommendations for Sublinox™ (zolpidem tartrate) come from the company Valeant Canada in order to minimize the risk of next-day impairment in both women and men.

Sublinox™ (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. The following points summarize the updated Product Monograph information concerning recommended dose and dosage adjustment:
&nbsp&nbsp&nbsp&nbsp&nbsp•&nbsp&nbspThe recommended initial dose has been revised to 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening.
&nbsp&nbsp&nbsp&nbsp&nbsp• &nbsp&nbspThe total dose of Sublinox™ should not exceed 10 mg once daily immediately before bedtime. The lowest effective dose for the patient should be used.
&nbsp&nbsp&nbsp&nbsp&nbsp• &nbsp&nbspIn some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.

The recommended initial doses for women and men are different because of lower rate of clearance and higher blood levels of zolpidem in women compared to men.

Health care professionals are also reminded that in geriatric patients (≥65 years of age), clearance rate of zolpidem is lower in both men and women when compared to young adults. The recommended dose of Sublinox™ in geriatric patients is 5 mg regardless of gender.


Jan 3, 2014: Royal Jelly recalled due to contamination with the antibiotic chloramphenicol


The company Alive Health Centre, in consultation with Health Canada, is voluntarily recalling two lots of its natural health product Alive Vitamins - Royal Jelly 1200 mg due to contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers. Chloramphenicol is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol.

Chloramphenicol is a prescription drug and should only be used under medical supervision in adults and children after careful consideration of the risks associated with it use. Other side effects that can be associated with chloramphenicol include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. In addition, it should not be used by pregnant or lactating women.

Products affected are:
Alive Vitamins - Royal Jelly 1200 mg (NPN 80034337) Lots: 21211147 and 21203128


Jan 23, 2014: Various Kinnikinnick Foods Brand products recalled due to undeclared milk


Kinnikinnick Foods is recalling the Kinnikinnick Foods brand products listed below from the marketplace because they contain milk which is not declared on the label. People with an allergy to milk should not consume the recalled products described below. The food recall warning issued on January 10, 2014 has been updated to include additional codes. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. The CFIA is verifying that industry is removing recalled products from the marketplace.

The following Kinnikinnick Foods brand products have been sold nationally.

Original Homestyle Waffles
Cinnamon & Brown Sugar Homestyle Waffles
Kinni-Kwik Bread & Bun Mix
Pancake & Waffle Mix
Panko Style Bread Crumbs


January 26, 2014: Complements Stir-Fry Vegetables may be contaminated with Listeria monocytogenes


Consumers are being warned not to consume Compliments brand Stir-Fry Style Vegetables due to a possible Listeria contamination. Affected products are the 340g (12oz) size with best before date as 14 Jan 21 and have been sold across Ontario. If you purchased this product and have it in your freezer you are advised to either throw it out or return it to the store it was purchased from. The item may not look or smell foul but will still make you sick. Those especially at risk are pregnant women and their unborn child as the infection can lead to premature delivery, illness of the newborn and even stillbirth. Symptoms of Listeriosis may include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness.


Dec 16, 2013: Lead found in Rublev Colour Paints and Varnish.


Health Canada has put out a recall on Rublev Colours Paints and Italian Varnish, commonly used in adult arts and crafts, as their random evaluation program found these products contain lead, a known neurotoxin. The manufacturer failed to label these products as such which may put many at risk of unexpected lead exposure, especially if ingested. These products are manufactured by Natural Pigments in the US however are distributed by ARTiculations in Toronto, Ontario. Approximately 94 recalled units have been sold during the period of November 2012 to November 2013. The Rublev Colours Paints were sold in 50 mL and 130 mL tubes, and the Rublev Colours Italian Varnish was sold in a 42 mL tube. Users are encouraged to should stop using the product and contact ARTiculations.

Products affected include:
Rublev Artists’ Oil paints
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead white 1
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead white 2
&nbsp&nbsp&nbsp&nbsp&nbsp- Venetian Medium
&nbsp&nbsp&nbsp&nbsp&nbsp- Flemish White
&nbsp&nbsp&nbsp&nbsp&nbsp- Crystal White
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead Tin Yellow
&nbsp&nbsp&nbsp&nbsp&nbsp- Naples Yellow (Lead Antimonate)
&nbsp&nbsp&nbsp&nbsp&nbsp- Naples Yellow Paris
&nbsp&nbsp&nbsp&nbsp&nbsp- Chrome Yellow Light
&nbsp&nbsp&nbsp&nbsp&nbsp- Chrome Yellow Medium
&nbsp&nbsp&nbsp&nbsp&nbsp- Minium (Red Light)
Rublev Colours Italian Varnish


Dec 18, 2013: Food Alert: Undeclared Gluten found in Aurora Brand Corn Gnocchi and Rice Gnocchi


The Canadian Food Inspection Agency found undeclared gluten in Aurora Brand Corn Gnocchi and Rice Gnocchi. The manufacturer, Aurora Importing & Distributing is recalling its Aurora Brand Corn Gnocchi (500g, all lots, with UPC code 0 61659 01811 2) as well as Aurora Brand Rice Gnocchi (500g, all lots, with UPC code 0 61659 01792 4) because they may contain gluten.

This recall was triggered by a consumer complaint. There has been one reported reaction associated with the consumption of these products. The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled the CFIA will notify the public through updated Food Recall Warnings. Those with celiac disease or gluten intolerance should avoid this product.