Important Information on Changes to Heparin Potency
2009-191
OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.
Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals. It is used, for example, as part of kidney dialysis or to prevent blood clots. Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.
Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used. However, there may be specific situations in a hospital setting that will require health care professionals to take this change in heparin potency under consideration, such as procedures where heparin is used as a single dose to achieve an immediate anti-clotting effect. In such procedures, blood monitoring may not necessarily occur.
When administering the drug, health care professionals should be aware of the potential difference in potency between heparin made under the old system and heparin made under the new system.
Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product. As well, following a heparin treatment, patients may notice they are being monitored more than before. This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.
As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time. This is necessary to ensure that there is no heparin shortage and patients can continue to receive treatments as scheduled. Health Canada is currently working with manufacturers to ensure that heparin products using the new standard are clearly identified during this transition.
Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
This document can be found on the Health Canada website.
Patients with questions or concerns about heparin should speak to their health care professional.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or call toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect™ Canada section of the Health Canada website
Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the
Health Canada website.
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Thursday, November 26, 2009
Tuesday, November 24, 2009
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.
Media Inquires: Siobhan DeLancey, siobhan.delancey@fda.hhs.gov, 301-796-4668
Consumer Inquires: 1-888-INFO-FDA
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. Sharkco’s History of Violations Prompts FDA to Seek Court Action
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.
“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”
According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.
No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products.
The company produces other seafood products, which are not affected by this action.
Consumer Inquires: 1-888-INFO-FDA
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. Sharkco’s History of Violations Prompts FDA to Seek Court Action
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.
“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”
According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.
No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products.
The company produces other seafood products, which are not affected by this action.
Monday, November 23, 2009
Press Statement on Corrosion in Homes and Connections to Chinese Drywall
U.S. Consumer Product Safety Commission
November 23, 2009
Press Statement on Corrosion in Homes and
Connections to Chinese Drywall
Results from a major indoor air study of 51 homes are being released today along with
initial reports from two studies of corrosion in homes with Chinese drywall. We now can
show a strong association between homes with the problem drywall and the levels of
hydrogen sulfide in those homes and corrosion of metals in those homes.
By identifying this association, the Interagency Drywall Task Force can now move
forward to develop protocols that will identify homes with this corrosive environment
and can determine the effectiveness of remediation methods. The Task Force continues to
work with Congressional and White House officials to determine the best approaches to
design and fund these identification and remediation efforts to help the families dealing
with this issue.
“We now have the science that enables the Task Force to move ahead to the next phase –
to develop both a screening process and effective remediation methods. Ongoing studies
will examine health and safety effects, but we are now ready to get to work fixing this
problem,” said U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum.
The Studies
The 51 home study contracted by CPSC was done by Environmental Health &
Engineering (EH&E), an internationally known environmental testing firm based in
Massachusetts.
In addition, today two preliminary reports on corrosion safety issues are being released.
The Sandia National Laboratories’ (SNL) Materials and Engineering Center is studying
the long-term electrical safety hazards of conductor metal components. The National
Institute of Standards and Technology (NIST) is studying the corrosion effects on fire
safety components taken from complaint homes.
Findings
EH&E compared 41 “complaint” homes in five states selected from CPSC’s consumer
incident report database, with 10 noncomplaint homes built around the same time in the
same area as the complaint homes. Homes were sampled between July and September
2009.
The EH&E findings are that hydrogen sulfide gas is the essential component that causes
copper and silver sulfide corrosion found in the complaint homes. Other factors,
including air exchange rates, formaldehyde and other air contaminants contribute to the
reported problems.
In ways still to be determined, hydrogen sulfide gas is being created in homes built with
Chinese drywall. Earlier studies found large amounts of elemental sulfur in the Chinese
drywall. CPSC is investigating drywall from other sources that may mimic the problems
found with Chinese drywall. CPSC is meeting with drywall manufacturers and others
who are studying this issue to take their findings into consideration.
EH&E exposed copper and silver test strips, known as coupons, in homes for a period of
about two weeks. The coupons showed significantly higher rates of corrosion in
complaint homes than in the control homes. The dominant species of corrosion on the
coupons was copper sulfide and silver sulfide, as determined by additional laboratory
tests. Visual inspection and evaluation of ground wire corrosion also revealed
statistically significant greater ground wire corrosion in complaint homes compared to
non-complaint homes.
The EH&E study also found that by using hand-held x-ray fluorescence (XRF) and
Fourier Transform Infrared (FTIR) instruments, they were able to detect markers that
could identify Chinese-made dry wall at a sheet-by-sheet level.
While drywall-related corrosion is clearly evident, long term safety effects are still under
investigation. Like the EH&E study, initial reports available today from SNL and NIST
show copper and silver sulfide corrosion on samples of metal taken from homes with
problem drywall. These ongoing investigations will help the CPSC identify the nexus of
problem drywall and long term safety issues.
In addition, the EH&E study found elevated formaldehyde readings in both the control
and complaint homes. This is typical for new, more air-tight homes due to items such as
cabinets and carpets which emit formaldehyde. Both formaldehyde and hydrogen sulfide
are known irritants at sufficiently high levels. The concentrations measured in this study
were below those levels. Investigators believe that the additive or synergistic effects of
these and other compounds in the subject homes could cause irritant effects evident in the
homes.
Next Steps
First, CPSC continues to search for homes exhibiting the corrosion and health effects
under study. In addition to a direct call to consumers, CPSC is contacting governors of all
states, all territories and the District of Columbia, to ensure that all homes with these
problems have been reported to CPSC.
Second, the Interagency Task Force established an Identification and Remediation
Protocol Team of scientists and engineers. This Team will use the results of the EH&E
study and other information to design a cost-effective screening protocol to identify
homes with this problem. Professional air sample testing, and destructive testing of
drywall can carry high costs. The Protocol Team will develop quick, cost-efficient
evaluation methods to identify homes with these problems. The Protocol Team will also
look at remediation protocols, to see what cost-efficiency improvements to current
remediation practices, if any, may be available, and what guidance should be issued on
doing the work safely.
Third, investigations currently underway by Lawrence Berkeley Laboratories, SNL and
NIST and others will continue toward identifying additional information on any possible
long-term health and safety issues.
The Identification and Remediation Protocol Team will use information from the EH&E
study and other information to begin evaluating remediation protocols. Homes that have
undergone remediation are expected to yield valuable information that will be helpful for
homeowners.
The Interagency Task Force is actively talking to Congressional and White House
officials about the best approaches to design and fund both the Identification and
Remediation efforts.
Other Ongoing Efforts
The Interagency Task Force, working with U.S. Customs and Border Protection, is
monitoring imports of possible Chinese drywall. We believe that no new Chinese drywall
has entered the United States in 2009. Owners of known U.S. inventories of Chinese
drywall have been notified of this ongoing investigation. They have indicated that the
drywall boards will not be sold. Further, CPSC has secured the cooperation of the
Chinese Government to help identify the sources and causes of this problem.
CPSC is working with an ASTM committee that has just initiated discussions on the
formulation of a proposed new standard on inspection of drywall for air quality issues.
Recommendations to Affected Homeowners
To date, CPSC has received more than 2000 reports from 32 states, the District of
Columbia and Puerto Rico from consumers and homeowners concerned about problem
drywall in their homes.
Homeowners who believe they may have problem drywall should immediately report to
CPSC by calling 800-638-2772 or logging on to www.CPSC.gov. Hearing- or speechchallenged
individuals may access the phone number through TTY by calling the toll-free
Federal Relay Service at 800-877-8339.
Federal and state health experts suggest these steps to improve indoor air quality and to
reduce exposure to substances that can cause health concerns:
o Open windows as much as possible to let in fresh air.
o Keep the temperature inside homes at the lowest comfortable setting.
o Run the air conditioner or dehumidifier.
o Also, spend as much time outdoors in fresh air as possible.
o Do not smoke, and especially do not smoke indoors. Cigarette smoke contains,
among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to
www.DrywallResponse.gov.
November 23, 2009
Press Statement on Corrosion in Homes and
Connections to Chinese Drywall
Results from a major indoor air study of 51 homes are being released today along with
initial reports from two studies of corrosion in homes with Chinese drywall. We now can
show a strong association between homes with the problem drywall and the levels of
hydrogen sulfide in those homes and corrosion of metals in those homes.
By identifying this association, the Interagency Drywall Task Force can now move
forward to develop protocols that will identify homes with this corrosive environment
and can determine the effectiveness of remediation methods. The Task Force continues to
work with Congressional and White House officials to determine the best approaches to
design and fund these identification and remediation efforts to help the families dealing
with this issue.
“We now have the science that enables the Task Force to move ahead to the next phase –
to develop both a screening process and effective remediation methods. Ongoing studies
will examine health and safety effects, but we are now ready to get to work fixing this
problem,” said U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum.
The Studies
The 51 home study contracted by CPSC was done by Environmental Health &
Engineering (EH&E), an internationally known environmental testing firm based in
Massachusetts.
In addition, today two preliminary reports on corrosion safety issues are being released.
The Sandia National Laboratories’ (SNL) Materials and Engineering Center is studying
the long-term electrical safety hazards of conductor metal components. The National
Institute of Standards and Technology (NIST) is studying the corrosion effects on fire
safety components taken from complaint homes.
Findings
EH&E compared 41 “complaint” homes in five states selected from CPSC’s consumer
incident report database, with 10 noncomplaint homes built around the same time in the
same area as the complaint homes. Homes were sampled between July and September
2009.
The EH&E findings are that hydrogen sulfide gas is the essential component that causes
copper and silver sulfide corrosion found in the complaint homes. Other factors,
including air exchange rates, formaldehyde and other air contaminants contribute to the
reported problems.
In ways still to be determined, hydrogen sulfide gas is being created in homes built with
Chinese drywall. Earlier studies found large amounts of elemental sulfur in the Chinese
drywall. CPSC is investigating drywall from other sources that may mimic the problems
found with Chinese drywall. CPSC is meeting with drywall manufacturers and others
who are studying this issue to take their findings into consideration.
EH&E exposed copper and silver test strips, known as coupons, in homes for a period of
about two weeks. The coupons showed significantly higher rates of corrosion in
complaint homes than in the control homes. The dominant species of corrosion on the
coupons was copper sulfide and silver sulfide, as determined by additional laboratory
tests. Visual inspection and evaluation of ground wire corrosion also revealed
statistically significant greater ground wire corrosion in complaint homes compared to
non-complaint homes.
The EH&E study also found that by using hand-held x-ray fluorescence (XRF) and
Fourier Transform Infrared (FTIR) instruments, they were able to detect markers that
could identify Chinese-made dry wall at a sheet-by-sheet level.
While drywall-related corrosion is clearly evident, long term safety effects are still under
investigation. Like the EH&E study, initial reports available today from SNL and NIST
show copper and silver sulfide corrosion on samples of metal taken from homes with
problem drywall. These ongoing investigations will help the CPSC identify the nexus of
problem drywall and long term safety issues.
In addition, the EH&E study found elevated formaldehyde readings in both the control
and complaint homes. This is typical for new, more air-tight homes due to items such as
cabinets and carpets which emit formaldehyde. Both formaldehyde and hydrogen sulfide
are known irritants at sufficiently high levels. The concentrations measured in this study
were below those levels. Investigators believe that the additive or synergistic effects of
these and other compounds in the subject homes could cause irritant effects evident in the
homes.
Next Steps
First, CPSC continues to search for homes exhibiting the corrosion and health effects
under study. In addition to a direct call to consumers, CPSC is contacting governors of all
states, all territories and the District of Columbia, to ensure that all homes with these
problems have been reported to CPSC.
Second, the Interagency Task Force established an Identification and Remediation
Protocol Team of scientists and engineers. This Team will use the results of the EH&E
study and other information to design a cost-effective screening protocol to identify
homes with this problem. Professional air sample testing, and destructive testing of
drywall can carry high costs. The Protocol Team will develop quick, cost-efficient
evaluation methods to identify homes with these problems. The Protocol Team will also
look at remediation protocols, to see what cost-efficiency improvements to current
remediation practices, if any, may be available, and what guidance should be issued on
doing the work safely.
Third, investigations currently underway by Lawrence Berkeley Laboratories, SNL and
NIST and others will continue toward identifying additional information on any possible
long-term health and safety issues.
The Identification and Remediation Protocol Team will use information from the EH&E
study and other information to begin evaluating remediation protocols. Homes that have
undergone remediation are expected to yield valuable information that will be helpful for
homeowners.
The Interagency Task Force is actively talking to Congressional and White House
officials about the best approaches to design and fund both the Identification and
Remediation efforts.
Other Ongoing Efforts
The Interagency Task Force, working with U.S. Customs and Border Protection, is
monitoring imports of possible Chinese drywall. We believe that no new Chinese drywall
has entered the United States in 2009. Owners of known U.S. inventories of Chinese
drywall have been notified of this ongoing investigation. They have indicated that the
drywall boards will not be sold. Further, CPSC has secured the cooperation of the
Chinese Government to help identify the sources and causes of this problem.
CPSC is working with an ASTM committee that has just initiated discussions on the
formulation of a proposed new standard on inspection of drywall for air quality issues.
Recommendations to Affected Homeowners
To date, CPSC has received more than 2000 reports from 32 states, the District of
Columbia and Puerto Rico from consumers and homeowners concerned about problem
drywall in their homes.
Homeowners who believe they may have problem drywall should immediately report to
CPSC by calling 800-638-2772 or logging on to www.CPSC.gov. Hearing- or speechchallenged
individuals may access the phone number through TTY by calling the toll-free
Federal Relay Service at 800-877-8339.
Federal and state health experts suggest these steps to improve indoor air quality and to
reduce exposure to substances that can cause health concerns:
o Open windows as much as possible to let in fresh air.
o Keep the temperature inside homes at the lowest comfortable setting.
o Run the air conditioner or dehumidifier.
o Also, spend as much time outdoors in fresh air as possible.
o Do not smoke, and especially do not smoke indoors. Cigarette smoke contains,
among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to
www.DrywallResponse.gov.
Thursday, November 19, 2009
FDA Takes Action Against Maryland Veal Calf Dealer, Sold animals for human consumption that contained illegal drug residues
Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against Maryland Veal Calf Dealer
Man allegedly sold animals for human consumption that contained illegal drug residues
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an “extralabel” manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.
Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle’s veal calves sampled by the U.S. Department of Agriculture.
Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia.
It also is indicated for the control of inflammation in endotoxemia.
The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.
Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr.
Nickle’s operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against Maryland Veal Calf Dealer
Man allegedly sold animals for human consumption that contained illegal drug residues
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an “extralabel” manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.
Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle’s veal calves sampled by the U.S. Department of Agriculture.
Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia.
It also is indicated for the control of inflammation in endotoxemia.
The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.
Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr.
Nickle’s operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.
Thursday, November 5, 2009
Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online
Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online
2009-179
OTTAWA - Health Canada and the Competition Bureau are advising Canadians not to purchase unauthorized products that claim to fight or prevent the H1N1 flu virus, from the Internet or other sources. Health Canada is working with the Competition Bureau and the Royal Canadian Mounted Police (RCMP) to address unauthorized products, including those with fraudulent claims to treat or prevent the H1N1 flu virus.
There are only three products authorized by Health Canada that should be used against the H1N1 flu virus: the H1N1 vaccine Arepanrix, and the antiviral drugs Tamiflu (oseltamivir) and Relenza (zanamivir). In addition, the distribution of 200,000 doses of unadjuvanted H1N1 vaccine Panvax from Australia has been authorized for use in pregnant women. Antivirals should only be purchased with a prescription from a health care practitioner who has examined the patient. The vaccines should be administered by a qualified health care practitioner, and are not available for sale to the public.
While there are legitimate Canadian Internet pharmacies, consumers should be aware of the risks associated with buying drugs online. For more information on the subject, Health Canada has published an It's Your Health article on Buying Drugs over the Internet. Health Canada will continue to monitor the Internet and to take action against Canadian Web sites selling unauthorized products for the treatment or prevention of the H1N1 flu virus, or any other health condition.
Combating health fraud also remains a priority for the Competition Bureau, a law enforcement agency that regularly monitors the Internet and takes enforcement action against false and misleading advertising. For information on the Bureau's activities in the area of health fraud, please visit: www.competitionbureau.gc.ca/healthfraud.
Health Canada and the Competition Bureau would also like to share the following advice with Canadians to avoid becoming victims of health fraud:
Beware of ads that "promise too much." Think twice before buying a product that claims it can "do it all." Steer clear of a product that claims to be a "scientific breakthrough." Don't be swayed by a questionable "success story" or so-called "patient testimonial." Consult your health care practitioner before trying any new treatment. Taking unapproved or counterfeit drugs could pose serious risks to health. These products may contain ingredients not listed on the label or dangerous additives, and could cause serious side effects. Authorized health products will display either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.* This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Canadians are encouraged to stay informed on the H1N1 flu virus by visiting the Public Health Agency of Canada's website, or calling the toll-free public information line at 1-800-454-8302.
Canadians with questions or complaints about counterfeit drugs and/or drugs purchased over the Internet can call Health Canada's toll-free line at 1-800-267-9675.
The Competition Bureau urges Canadians who come across a Web site promoting a treatment or cure that seems too good to be true, to call toll free (1-800-348-5358) or go to www.competitionbureau.gc.ca/info.
Health Canada issued an advisory about the online purchase of Tamiflu in December 2005.
* The manufacturer of Arepanrix has been exempted from the DIN labelling requirement to
avoid delays in the labelling and delivery of the vaccine.
Media Enquiries:Health Canada(613) 957-2983
Competition Bureau(819) 953-4257
Public Enquiries (Health Canada):(613) 957-29911-866 225-0709
Public Enquiries (Competition Bureau):1-800-348-5358
2009-179
OTTAWA - Health Canada and the Competition Bureau are advising Canadians not to purchase unauthorized products that claim to fight or prevent the H1N1 flu virus, from the Internet or other sources. Health Canada is working with the Competition Bureau and the Royal Canadian Mounted Police (RCMP) to address unauthorized products, including those with fraudulent claims to treat or prevent the H1N1 flu virus.
There are only three products authorized by Health Canada that should be used against the H1N1 flu virus: the H1N1 vaccine Arepanrix, and the antiviral drugs Tamiflu (oseltamivir) and Relenza (zanamivir). In addition, the distribution of 200,000 doses of unadjuvanted H1N1 vaccine Panvax from Australia has been authorized for use in pregnant women. Antivirals should only be purchased with a prescription from a health care practitioner who has examined the patient. The vaccines should be administered by a qualified health care practitioner, and are not available for sale to the public.
While there are legitimate Canadian Internet pharmacies, consumers should be aware of the risks associated with buying drugs online. For more information on the subject, Health Canada has published an It's Your Health article on Buying Drugs over the Internet. Health Canada will continue to monitor the Internet and to take action against Canadian Web sites selling unauthorized products for the treatment or prevention of the H1N1 flu virus, or any other health condition.
Combating health fraud also remains a priority for the Competition Bureau, a law enforcement agency that regularly monitors the Internet and takes enforcement action against false and misleading advertising. For information on the Bureau's activities in the area of health fraud, please visit: www.competitionbureau.gc.ca/healthfraud.
Health Canada and the Competition Bureau would also like to share the following advice with Canadians to avoid becoming victims of health fraud:
Beware of ads that "promise too much." Think twice before buying a product that claims it can "do it all." Steer clear of a product that claims to be a "scientific breakthrough." Don't be swayed by a questionable "success story" or so-called "patient testimonial." Consult your health care practitioner before trying any new treatment. Taking unapproved or counterfeit drugs could pose serious risks to health. These products may contain ingredients not listed on the label or dangerous additives, and could cause serious side effects. Authorized health products will display either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.* This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Canadians are encouraged to stay informed on the H1N1 flu virus by visiting the Public Health Agency of Canada's website, or calling the toll-free public information line at 1-800-454-8302.
Canadians with questions or complaints about counterfeit drugs and/or drugs purchased over the Internet can call Health Canada's toll-free line at 1-800-267-9675.
The Competition Bureau urges Canadians who come across a Web site promoting a treatment or cure that seems too good to be true, to call toll free (1-800-348-5358) or go to www.competitionbureau.gc.ca/info.
Health Canada issued an advisory about the online purchase of Tamiflu in December 2005.
* The manufacturer of Arepanrix has been exempted from the DIN labelling requirement to
avoid delays in the labelling and delivery of the vaccine.
Media Enquiries:Health Canada(613) 957-2983
Competition Bureau(819) 953-4257
Public Enquiries (Health Canada):(613) 957-29911-866 225-0709
Public Enquiries (Competition Bureau):1-800-348-5358
Wednesday, November 4, 2009
The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts
The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts
2009-178
Health Canada and the Canadian Food Inspection Agency are reminding Canadians that raw or undercooked sprouts should not be eaten by children, the elderly, pregnant women or those with weakened immune systems.
Sprouts, such as alfalfa and mung beans, are a popular choice for Canadians as a low-calorie, healthy ingredient for many meals. Onion, radish, mustard and broccoli sprouts, which are not to be confused with the actual plant or vegetable, are also common options.
These foods, however, may carry harmful bacteria such as Salmonella and E. coli O157:H7, which can lead to serious illness.
Fresh produce can sometimes be contaminated with harmful bacteria while in the field or during storage or handling. This is particularly a concern with sprouts. Many outbreaks of Salmonella and E. coli infections have been linked to contaminated sprouts. The largest recent outbreak in Canada was in the fall of 2005, when more than 648 cases of Salmonella were reported in Ontario.
Children, the elderly, pregnant women and those with weakened immune systems are particularly vulnerable to these bacteria and should not eat any raw sprouts at all. They should also avoid eating cooked sprouts unless they can be sure the sprouts have been thoroughly cooked.
Healthy adults who choose to eat sprouts should take precautions to reduce their risk of exposure to sprout-borne bacteria. When purchasing sprouts, always select crisp ones that have been refrigerated and avoid those that appear dark or smell musty. Always use tongs or a glove to place the sprouts in a plastic bag. If possible, when eating in a restaurant, always make sure that the sprouts are fully cooked.
Symptoms from Salmonella usually occur 12 to 36 hours after eating contaminated food while symptoms from E. coli O157:H7 can occur within two to 10 days. Symptoms can include nausea, diarrhea, vomiting, fever and stomach cramps. People who experience these symptoms should contact a doctor immediately. In extreme cases, E. coli O157:H7 can lead to acute kidney failure or even death.
Health Canada and the Canadian Food Inspection Agency continue to work with producers to develop and implement best practices that will reduce the chances of sprouts becoming contaminated. Health Canada's Policy on Managing Health Risks Associated with the Consumption of Sprouted Seeds and Beans was released with this in mind.
More information, including Health Canada's policy on sprouts, can be found on Health Canada's Sprouts Information Page.
Media Enquiries:Health Canada(613) 957-2983
Canadian Food Inspection Agency(613) 773-6600
Public Enquiries:(613) 957-29911-866 225-0709
2009-178
Health Canada and the Canadian Food Inspection Agency are reminding Canadians that raw or undercooked sprouts should not be eaten by children, the elderly, pregnant women or those with weakened immune systems.
Sprouts, such as alfalfa and mung beans, are a popular choice for Canadians as a low-calorie, healthy ingredient for many meals. Onion, radish, mustard and broccoli sprouts, which are not to be confused with the actual plant or vegetable, are also common options.
These foods, however, may carry harmful bacteria such as Salmonella and E. coli O157:H7, which can lead to serious illness.
Fresh produce can sometimes be contaminated with harmful bacteria while in the field or during storage or handling. This is particularly a concern with sprouts. Many outbreaks of Salmonella and E. coli infections have been linked to contaminated sprouts. The largest recent outbreak in Canada was in the fall of 2005, when more than 648 cases of Salmonella were reported in Ontario.
Children, the elderly, pregnant women and those with weakened immune systems are particularly vulnerable to these bacteria and should not eat any raw sprouts at all. They should also avoid eating cooked sprouts unless they can be sure the sprouts have been thoroughly cooked.
Healthy adults who choose to eat sprouts should take precautions to reduce their risk of exposure to sprout-borne bacteria. When purchasing sprouts, always select crisp ones that have been refrigerated and avoid those that appear dark or smell musty. Always use tongs or a glove to place the sprouts in a plastic bag. If possible, when eating in a restaurant, always make sure that the sprouts are fully cooked.
Symptoms from Salmonella usually occur 12 to 36 hours after eating contaminated food while symptoms from E. coli O157:H7 can occur within two to 10 days. Symptoms can include nausea, diarrhea, vomiting, fever and stomach cramps. People who experience these symptoms should contact a doctor immediately. In extreme cases, E. coli O157:H7 can lead to acute kidney failure or even death.
Health Canada and the Canadian Food Inspection Agency continue to work with producers to develop and implement best practices that will reduce the chances of sprouts becoming contaminated. Health Canada's Policy on Managing Health Risks Associated with the Consumption of Sprouted Seeds and Beans was released with this in mind.
More information, including Health Canada's policy on sprouts, can be found on Health Canada's Sprouts Information Page.
Media Enquiries:Health Canada(613) 957-2983
Canadian Food Inspection Agency(613) 773-6600
Public Enquiries:(613) 957-29911-866 225-0709
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