Health Canada warns against use of Vigoureux

From CTV News:
Health Canada is warning consumers not to use an unauthorized product promoted for the treatment of erectile dysfunction.

In a release issued Friday, officials said the product, Vigoureux, may pose serious health risks, as it was found to contain the prescription drug sildenafil which is not indicated on the product label and should only be used under the supervision of a health-care professional.

Patients with pre-existing medical conditions, including those with heart problems, taking heart medications or at risk for strokes, may be at an increased risk of serious health effects associated with the use of Vigoureux.

Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. ...more

Further Details on Recall of Contaminated Heparin

From Health Canada:
The following is to update Canadians on the recall of contaminated lots of heparin products from B. Braun Medical Inc., and the ongoing testing of the heparin supply in Canada.

The presence of a contaminant in the active pharmaceutical ingredients of certain lots of B. Braun heparin products was first identified by Health Canada and communicated to Canadians on March 20, 2008. This contaminant has been found in the following specific products and lots, which are being recalled ...more

SEBIVO (telbivudine) - Advisories, Warnings & Recalls

From Health Canada:
Novartis Pharmaceuticals Canada Inc., in consultation with Health Canada, would like to inform you of an increased risk of peripheral neuropathy observed in chronic hepatitis B patients treated with telbivudine (SEBIVO®) in combination with peginterferon alfa-2a (Pegasys®), compared to the interferon or telbivudine alone, during a controlled pilot clinical trial. An increased risk cannot be ruled out for treatments combining telbivudine with other interferon products (pegylated or standard).
For health care professionals
For the public

Drug to treat excess iron in blood may cause liver problems: Health Canada

From the Canadian Press:
Health Canada is updating safety information for a drug used to treat chronic iron overload from blood transfusions after reports of severe, even potentially fatal, liver problems in some people using the medication.

Exjade (deferasirox), made by Novartis, is used to treat excess iron accumulation in the blood following transfusions for anemia in adults, adolescents and children aged six and over. Children under six cannot be adequately treated with the drug.

Cases of severe liver problems - some causing death - have been reported internationally following Exjade's approval for widespread use in various countries, including Canada.

As of Oct. 31, 2007, almost 37,000 patients have been treated with Exjade worldwide. In all, there have been 24 reports of liver failure - two of them in Canada. Most of these cases involved patients that already had multiple medical conditions, including liver disease (cirrhosis) and multiple organ failure. ...more

Exjade warning from Health Canada for health professionals

Exjade warning from Health Canada for the public

Fentanyl pain patches recalled in Canada

From CTV News:
In the latest of several alerts on the safety of fentanyl pain-relief patches, Health Canada has announced the recall of two brands of the powerful patches.

The agency advises against using:

* 25 mcg/hr Duragesic (fentanyl transdermal system) patches sold by Janssen-Ortho Inc.
* 25 mcg/hr Ran Fentanyl Transdermal System patches sold by Ranbaxy.

Both products are being voluntarily recalled because they may have a cut along one side of the patch that could result in leaking of the fentanyl gel from the patch.

"Exposure to fentanyl gel that has leaked from the patch may lead to increased skin absorption and could result in serious, potentially life-threatening adverse events, including respiratory depression (slowed breathing) and possible overdose, which may be fatal," Health Canada said in its warning. ...more

Health Canada issues warning against two stomach treatments

From Canada.com:
Health Canada is telling parents not to use two natural products for treating upset stomachs in infants and children because of potential bacterial contamination.

Baby's Bliss Gripe Water, apple flavour, 26952V, is a natural health product given to babies to "ease stomach discomfort and gas often associated with colic, hiccups and teething," Health Canada said in an alert to consumers.

The product is distributed by MOM Enterprises, Inc. in California and is sold in a 118.26 millilitre plastic bottle in a cardboard carton. The label reads: Baby's Bliss Pediatrician Recommended Gripe Water Apple Flavor.

The U.S. Food and Drug Administration found the product contains the parasite cryptosporidium which can infect the gastrointestinal tract. "Infections due to cryptosporidium may cause watery diarrhea, abdominal cramps, vomiting and, in some cases, death," Health Canada said. ...more

New safety warnings regarding ALERTEC® * (modafinil) and serious rash, allergic reactions, and mental problems

From Health Canada:
Alertec® (modafinil) is used to relieve excessive sleepiness due to medical conditions called narcolepsy (uncontrollable, brief episodes of daytime sleepiness), obstructive sleep apnea/hypopnea syndrome (breathing abnormalities during sleep) and shift work sleep disorder. Shire Canada Inc., in consultation with Health Canada, would like to inform you of new safety information regarding Alertec®:
For Health Professionals
For the Public

Mumps vaccine being probed for allergy links

From the Globe and Mail:
Health officials across the country are being told to stop using a measles, mumps and rubella vaccine that is now being investigated for possible links to six cases of serious allergic reactions in patients in Alberta.

All six people, who were treated and have fully recovered, received an inoculation from the same batch of a product known as MMR-II, which is sold by Merck Frosst Canada Ltd. They experienced anaphylaxis, a potentially fatal reaction.

But the Quebec-based company said two other lots of the vaccine were made with the same material and are affected by Health Canada's warning to suspend use until a probe is completed. ...more

Manufacturer restricts use of diabetes drug Avandia

From CBC News:
The manufacturer of a drug for treating Type 2 diabetes has placed new restrictions on use of the medication based on a Health Canada review of clinical data pointing to an increased risk of heart-related problems in some patients.

GlaxoSmithKline Inc., in consultation with Health Canada, is updating prescribing information on products made from or containing the drug rosiglitazone: Avandia, Avandamet and AvandarylTM.

Once touted as the gold standard for preventing Type 2 diabetes in high-risk patients, rosiglitazone lost its glitter after a study published in the New England Journal of Medicine in May showed Avandia significantly raised the risk of heart attack and possible death. ...more

New restrictions on the use of rosiglitazone products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)

From Health Canada:

GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on the treatment of type 2 diabetes mellitus with the rosiglitazone-containing products: AVANDIA® (rosiglitazone), AVANDAMET® (rosiglitazone and metformin), and AVANDARYLTM (rosiglitazone and glimepiride).

Further to a Health Canada assessment of adverse event reports, published articles* and other available information on congestive heart failure, myocardial infarction, and related events, the Canadian Product Monographs for rosiglitazone-containing products are being updated and will include the following new usage restrictions: ...more

Bayer Stops Sales of Trasylol Globally

I think this article would be a good one to file in the memory banks. The next time American experts say there is no drug research being done in Canada, here's an example that contradicts that statement.

From the Associated Press:
Bayer AG halted worldwide sales Monday of its anti-bleeding drug Trasylol at the request of U.S. and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50 percent higher risk of death than the other drugs in the clinical trial.

The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, until it could receive and review further results from the study. The study comparing the safety and efficacy of the drug with two others was recently halted.

"FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk," said Dr. John Jenkins, director of the agency's Office of New Drugs, during a briefing Monday. ...more

KETEK® is no longer approved for the treatment of bronchitis, sinusitis or tonsillitis/pharyngitis

From Health Canada:
Upon review of the available safety information, including reported cases of severe liver injury, Health Canada has determined that the benefit-risk profile for KETEK® no longer supports its use for the treatment of acute exacerbation of chronic bronchitis (AECB), acute bacterial sinusitis (ABS) or tonsillitis/pharyngitis. These indications will be removed from the label.
For health care professionals
For the public

Health Canada Endorsed Important Safety Information on THELIN (sitaxsentan sodium)

From Health Canada:
Encysive Pharmaceuticals Inc., in consultation with Health Canada, wishes to highlight important safety information for the safe and appropriate prescribing and use of THELIN™ (sitaxsentan sodium).

THELIN (sitaxsentan sodium) is indicated for treatment of primary pulmonary arterial hypertension or pulmonary hypertension secondary to connective tissue disease, in patients with WHO functional class III who have not responded to conventional therapy. THELIN is also indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified.
For Health Professionals

'Sleepees' herbal pills contain prescription drugs

From CTV News:
Thousands of Canadians turn to herbal remedies to help them get a good night's sleep, believing that because the products are all-natural, there's no risk of addiction.

But some have found this is not always the case. Health Canada has recalled five herbal products in recent months because they contained potentially addictive prescription drugs. That's sparked a number of class action lawsuits against the manufacturers as well as worries that many Canadians may still be using these potentially addictive products.

Leslie Alexander and Brenda Connell suffered from insomnia, as many Canadians do. According to a recent study by Statistics Canada, one in every seven Canadians aged 15 or older -- about 3.3 million of us -- have trouble going to sleep or staying asleep. ...more

Health Canada Endorsed Important Safety Information on Rituxan (rituximab)

From Health Canada:
Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning RITUXAN (rituximab).

RITUXAN is authorized in Canada for the treatment of non-Hodgkin’s lymphoma (a cancer of the lymph nodes) and rheumatoid arthritis (an inflammatory disease of the joints).
For health care professionals
For the public

Health Canada investigates Losec, Nexium for heart risks

From CBC News:
Health Canada is alerting consumers who take Losec and Nexium, two prescription medications primarily used to treat acid-related stomach disorders, that it is investigating the drugs' links to serious cardiac problems.

Studies of the two medications reveal that patients using Losec or Nexium to treat gastroesophageal reflux disease (GERD) instead of surgery "may have experienced more heart attacks or cardiac deaths than patients who had the surgery," reads the advisory.

It also notes that many patients who developed cardiac problems had risk factors prior to beginning treatment. ...more

Unauthorized Smoking Cessation Product Resolve May Pose Health Risk

From Health Canada:
Health Canada is advising Canadians not to use the unauthorized smoking cessation product Resolve, because of the potential health risk to consumers.

The product contains an unacceptable amount of an ingredient labelled as "CESTEMENOL-350." Consuming excessive amounts of this ingredient might result in damage to the kidney, liver or red blood cells.

Resolve is advertised as a natural stop smoking aid and is available in Cool Peppermint and Wild Cherry flavours. Resolve is distributed by The Winning Combination Inc. These products have been sold in retail stores across the country and are also available over the Internet.

Resolve is not authorized for sale in Canada and Health Canada has asked the company to recall the products. To date, the company has not complied with Health Canada's request. Health Canada will take further action to remove the product from the market. ...more

Unauthorized drug being sold on Canadian shelves, despite warnings

From the Montreal Gazette:
Health Canada is trying to halt the sale and use of Resolve, a product used to help quit smoking, because of a potential health risk to consumers.

Despite not being authorized for sale in Canada, the products is sold in retail stores across the country, and is also available over the Internet.

Health Canada has asked the company to recall the products, but the company has not taken Resolve off the market, said a press release on Saturday. ...more

Warning against over-the-counter sleep aids

From CTV News:
Health Canada is advising consumers not to use a sleep aid product called Optimum Health Care Sleep Easy because it contains an undeclared drug that can be habit-forming.

The department says the drug, clonazepam, is known to be habit-forming after even a few months of use.

Health Canada says people who have been using the product should consult with a health-care professional before they stop taking the pills, because of the risk of serious withdrawal symptoms. ...more

Sensipar® no longer indicated for chronic kidney disease patients (stages 3 and 4) not receiving dialysis

From Health Canada:
The following updated information has been provided recently to healthcare professionals to review with their patients when prescribing Sensipar®.

Sensipar® has been authorized in Canada since 2004 for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD). Recently, a study was conducted with the intent of providing further evidence of the efficacy and safety of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis. The results of this study showed that while cinacalcet effectively lowered PTH, the incidence of serum calcium levels below the lower limit of the normal range (8.4 mg/dL [2.1 mmol/L]) with cinacalcet treatment was higher than that observed in patients with secondary HPT and CKD receiving dialysis. As such, Amgen considers that this study has not provided evidence of a positive risk to benefit profile of use of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis.
For the public
For health professionals