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SAFETY BULLETINS

May 9, 2014 Drug Alert: Health Canada suspends license of Biolyse Pharma, but supply of paclitaxel will not be disrupted for Canadians

Health Canada confirmed it has suspended the establishment licence of Biolyse Pharma Corporation's facility in St. Catharines, Ont., because of significant concerns with the manufacturing process discovered during a recent inspection. Injectable paclitaxel (6mg/ml), used in the treatment of certain lung and breast cancers, is currently the only drug produced at that facility. The suspension of the establishment license means Biolyse is not permitted to sell paclitaxel from that facility to the Canadian market until the serious manufacturing concerns are fully addressed and the suspension on their establishment licence is lifted. To receive and maintain an establishment licence in Canada, a company must comply with Good Manufacturing Practices (GMP), which help to ensure that the drugs sold in Canada are safe, effective and of high quality. These guidelines are applied to all companies and are widely known.

Health Canada has confirmed that supplies of paclitaxel are available from another manufacturer that is licenced to produce it in Canada. The Department is also in regular contact with the provinces and territories regarding the supply situation. There has been no supply disruption caused by the licence suspension. In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment. However, Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved. Patients currently being treated with paclitaxel from Biolyse should speak to their healthcare professional if they have concerns with their treatment. Health Canada officials continue to work with the staff at Biolyse Pharma to resolve the issues identified during the inspection as quickly as possible.

May 9, 2014 Food Alert: Selection brand Rosemary Leaves recalled due to Salmonella

Nador Inc. is recalling Selection brand Rosemary Leaves from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product described below.

Check to see if you have recalled product in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

May 7, 2014
Drug Alert: Association of TEMODAL® (temozolomide) with the risk of liver problems.


Merck Canada Inc., in consultation with Health Canada, would like to inform you of new important safety information about TEMODAL® (temozolomide) and risk of liver problems. TEMODAL® is an antitumor agent used in combination with radiotherapy in the treatment and maintenance therapy of some brain cancers. TEMODAL® may cause liver problems which may, in some cases, result in death. Liver problems may occur several weeks after starting treatment with TEMODAL® or after treatment has been stopped. If you are using TEMODAL®, your doctor will be monitoring you for signs of liver problems with blood tests as appropriate for your condition. It is important to tell your doctor if you already have liver problems.

Contact your doctor if your skin or the whites of your eyes turn yellow, you feel tired or have flu-like symptoms, your urine is dark or brown, your stools are discoloured and/or pale, you experience itching, you have nausea or vomiting, you have pain on the right side of your stomach just below the ribs, or you do not have an appetite. These may be signs of liver problems. Merck Canada Inc. has sent a letter to health care professionals informing them of this important safety information.


April 17, 2014 Food Alerts: Noah's Natural Foods is recalling organic black peppercorns from the marketplace due to possible Salmonella contamination.


Noah's Natural Foods is recalling organic black peppercorns from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product. There is no brand name associated with the product (it is sold in bulk as Organic Black Peppercorn). Locations include Noah's Natural Foods @ 322 Bloor St. West, Toronto and Noah's Natural Foods @ 2395 Yonge St., Toronto.

Check to see if you have recalled product in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.


April 17, 2014 Product Recall: Kiss My Face, LLC Recalls Foaming Soaps due to possible bacterial contamination.


Kiss My Face, LLC is recalling their foaming soaps that were sold from November 5, 2012 until March 13, 2014. The recalled products are contaminated with the bacteria Pseudomonas aeruginosa and Pseudomonas fluorescens. Pseudomonas species can enter the body through cuts and lesions and may cause local infections in people with weakened immune systems. Neither the company nor Health Canada has received any reports of consumer incidents or injuries related to the use of these products. Approximately 19,000 units of the affected products were sold in Canada.

Consumers should immediately stop using the recalled products even if it does not look or smell spoiled. Consumers who purchased any of the lots being recalled are advised to return the product container to the original point of purchase for reimbursement. Alternatively consumers can contact Kiss My Face directly at 1-800-262-5477 (Monday to Friday, 9:00 a.m. to 5:00 p.m. EST, available in English only), or via email at customerservice@kissmyface.com.


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.