From the Globe and Mail:
Just one year after it was approved for use in Canada, federal health officials are investigating safety concerns about smoking cessation prescription drug Champix amid fears it is linked to suicide and serious psychological problems.
The investigation and reports of major side effects highlight what many medical experts describe as chronic problems with the way new drugs are approved in Canada and the ability of government officials to adequately monitor them once they're put on the market.
"Existing systems don't really seem to be adequate," said David Henry, chief executive officer of the Institute for Clinical Evaluative Sciences in Toronto. "That means often times the studies that are the basis for market approval are not large enough to test for safety properly." ...more
Showing posts with label smoking cessation. Show all posts
Showing posts with label smoking cessation. Show all posts
Tuesday, February 05, 2008
Saturday, February 02, 2008
Quit-smoking drug linked to serious psychiatric side-effects: FDA
From the Canadian Press:
The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.
Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.
The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.
"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory. ...more
The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.
Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.
The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.
"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory. ...more
Tuesday, July 31, 2007
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
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
Sunday, July 29, 2007
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
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
Sunday, July 22, 2007
Not enough doctors advise smokers to butt out: report
From CBC News:
Doctors and other health-care professionals seem to be missing chances to help patients quit smoking, according to a report based on a large Canadian survey.
The 2005 government survey concluded half of smokers who visited health-care providers in the preceding 12 months got advice about quitting, suggesting that doctors, dentists and pharmacists need to take greater advantage of opportunities to provide such advice.
The report was published this week in the Morbidity and Mortality Weekly Report, a public health journal by the U.S. Centers for Disease Control in Atlanta. Its findings are based on a Health Canada survey of the smoking habits of more than 20,000 people aged 15 and older that suggested 19 per cent of Canadians smoked in 2005. ...more
Doctors and other health-care professionals seem to be missing chances to help patients quit smoking, according to a report based on a large Canadian survey.
The 2005 government survey concluded half of smokers who visited health-care providers in the preceding 12 months got advice about quitting, suggesting that doctors, dentists and pharmacists need to take greater advantage of opportunities to provide such advice.
The report was published this week in the Morbidity and Mortality Weekly Report, a public health journal by the U.S. Centers for Disease Control in Atlanta. Its findings are based on a Health Canada survey of the smoking habits of more than 20,000 people aged 15 and older that suggested 19 per cent of Canadians smoked in 2005. ...more
Sunday, April 08, 2007
Pharmacies offer smokers chance to butt out
From the Mississauga News:
Two Shoppers Drug Marts in Mississauga are among 55 pharmacies across Ontario that have signed on to help smokers kick the habit.
The stores will supply five weeks' worth of free nicotine replacement therapy (NRT) to selected smokers who want to quit.
In a promotion announced yesterday, the Ontario Pharmacists' Association (OPA), the Centre for Addiction and Mental Health (CAMH) and the Ministry of Health said as many as 5,000 Ontarians will receive the free therapy. The effort is part of a Smoking Treatment for Ontario Patients (STOP) study. ...more
Two Shoppers Drug Marts in Mississauga are among 55 pharmacies across Ontario that have signed on to help smokers kick the habit.
The stores will supply five weeks' worth of free nicotine replacement therapy (NRT) to selected smokers who want to quit.
In a promotion announced yesterday, the Ontario Pharmacists' Association (OPA), the Centre for Addiction and Mental Health (CAMH) and the Ministry of Health said as many as 5,000 Ontarians will receive the free therapy. The effort is part of a Smoking Treatment for Ontario Patients (STOP) study. ...more
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