What is triclosan?
Triclosan is an ingredient added to many consumer products to reduce or prevent bacterial contamination. It may be found in products such as clothing, kitchenware, furniture, and toys. It also may be added to antibacterial soaps and body washes, toothpastes, and some cosmetics—products regulated by the U.S. Food and Drug Administration (FDA).
What is known about the safety of triclosan?
Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review.
Animal studies have shown that triclosan alters hormone regulation. However, data showing effects in animals don’t always predict effects in humans. Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.
In light of these studies, FDA is engaged in an ongoing scientific and regulatory review of this ingredient. FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.
Does triclosan provide a benefit in consumer products?
For some consumer products, there is clear evidence that triclosan provides a benefit. In 1997, FDA reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste. The evidence showed that triclosan in this product was effective in preventing gingivitis.
For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.
What consumers should know:
Triclosan is not known to be hazardous to humans.
FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.
In light of questions raised by recent animal studies of triclosan, FDA is reviewing all of the available evidence on this ingredient’s safety in consumer products. FDA will communicate the findings of its review to the public in spring 2011.
At this time, FDA does not have evidence that triclosan added to antibacterial soaps and body washes provides extra health benefits over soap and water. Consumers concerned about using hand and body soaps with triclosan should wash with regular soap and water.
Consumers can check product labels to find out whether products contain triclosan.
How can I tell if there is triclosan in a product that I am using?
Antibacterial soaps and body washes, and toothpastes are considered over-the-counter drugs. If an over-the-counter drug contains triclosan, it will be listed as an ingredient on the label, in the Drug Facts box. If a cosmetic contains triclosan, it will be included in the ingredient list on the product label.
What is FDA doing to evaluate the safety of triclosan?
We are engaged in an ongoing scientific and regulatory review of the safety of triclosan in FDA-regulated products. We also have partnered with other Federal Agencies to study the effects of this substance on animal and environmental health (see http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm4; http://www.epa.gov/endo/5).
FDA is working to incorporate the most up-to-date data and information into the regulations that govern the use of triclosan in consumer products. FDA will communicate the findings of its review to the public in spring 2011.
This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.
Thursday, April 8, 2010
Monday, March 29, 2010
It’s called the Consumer Recall Notification Act – and it has the potential to drastically change the way you have to manage a recall
It’s called the Consumer Recall Notification Act – and it has the potential to drastically change the way you have to manage a recall. This bill is just one more of the many reasons why food manufacturers and retailers must pay attention to changes in the rules governing their business on a daily basis. It is critical that food manufacturers heed this warning and revisit their recall plans to make sure they are ready to manage a recall effectively and in compliance with fast changing recall regulations.
Introduced by Senator Kristen Gillibrand (D-NY), the proposed legislation would change several aspects of the recall process that many say need repair. Lawmakers, regulators, and consumer activists are increasingly concerned about food safety issues, such as the increasing health-related costs of food-borne illness.
The Gillibrand proposal could end up as part of the Food Safety Modernization Act that would have a major impact on recall execution for food manufacturers and retailers alike. Specifically, Senator Gillibrand’s bill seeks to improve recall notification measures for food recalls in three areas: consumer notification, distribution of information to restaurants and food retailers, and distribution of information to health workers.
FULL STORY: http://www.expertrecall.com/senator-proposes-changes-to-recall-notification-requirements/
Introduced by Senator Kristen Gillibrand (D-NY), the proposed legislation would change several aspects of the recall process that many say need repair. Lawmakers, regulators, and consumer activists are increasingly concerned about food safety issues, such as the increasing health-related costs of food-borne illness.
The Gillibrand proposal could end up as part of the Food Safety Modernization Act that would have a major impact on recall execution for food manufacturers and retailers alike. Specifically, Senator Gillibrand’s bill seeks to improve recall notification measures for food recalls in three areas: consumer notification, distribution of information to restaurants and food retailers, and distribution of information to health workers.
FULL STORY: http://www.expertrecall.com/senator-proposes-changes-to-recall-notification-requirements/
Sunday, March 28, 2010
Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Stephanie Kwisnek, 301-436-1856, stephanie.kwisnek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk
Latest outbreak of campylobacteriosis in Midwest is linked to unpasteurized product
The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever.
The FDA is collaborating with the Michigan Department of Community Health (MDCH), the Illinois Department of Public Health, the Indiana State Board of Animal Health and the Indiana State Health Department, to investigate the outbreak. MDCH reports that, as of March 24, 2010, it received reports of 12 confirmed cases of illness from Campylobacter infections in consumers who drank raw milk. The raw milk originated from Forest Grove Dairy in Middlebury, Ind.
Raw milk is unpasteurized milk from hoofed mammals, such as cows, sheep, or goats. Raw milk may contain a wide variety of harmful bacteria – including Salmonella, E. coli O157:H7, Listeria, Campylobacter and Brucella -- that may cause illness and possibly death. Public health authorities, including FDA and the Centers for Disease Control and Prevention, have expressed concerns about the hazards of drinking raw milk for decades.
Symptoms of illness caused by various bacteria commonly found in raw milk may include vomiting, diarrhea, abdominal pain, fever, headache and body ache. Most healthy individuals recover quickly from illness caused by raw milk. However, some people may have more severe illness, and the harmful bacteria in raw milk can be especially dangerous for pregnant women, the elderly, infants, young children and people with weakened immune systems.
If consumers of raw milk are experiencing one or more of these symptoms after consuming raw milk or food products made from raw milk, they should contact their health care provider immediately.
Since 1987, the FDA has required all milk packaged for human consumption to be pasteurized before being delivered for introduction into interstate commerce. Pasteurization, a process that heats milk to a specific temperature for a set period of time, kills bacteria responsible for diseases, such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria and brucellosis. FDA’s pasteurization requirement also applies to other milk products, with the exception of a few aged cheeses.
From 1998 to 2008, 85 outbreaks of human infections resulting from consumption of raw milk were reported to CDC. These outbreaks included a total of 1,614 reported illnesses, 187 hospitalizations and 2 deaths. Because not all cases of foodborne illness are recognized and reported, the actual number of illnesses associated with raw milk likely is greater.
Proponents of drinking raw milk often claim that raw milk is more nutritious than pasteurized milk and that raw milk is inherently antimicrobial, thus making pasteurization unnecessary. There is no meaningful nutritional difference between pasteurized and raw milk, and raw milk does not contain compounds that will kill harmful bacteria.
Stephanie Kwisnek, 301-436-1856, stephanie.kwisnek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk
Latest outbreak of campylobacteriosis in Midwest is linked to unpasteurized product
The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever.
The FDA is collaborating with the Michigan Department of Community Health (MDCH), the Illinois Department of Public Health, the Indiana State Board of Animal Health and the Indiana State Health Department, to investigate the outbreak. MDCH reports that, as of March 24, 2010, it received reports of 12 confirmed cases of illness from Campylobacter infections in consumers who drank raw milk. The raw milk originated from Forest Grove Dairy in Middlebury, Ind.
Raw milk is unpasteurized milk from hoofed mammals, such as cows, sheep, or goats. Raw milk may contain a wide variety of harmful bacteria – including Salmonella, E. coli O157:H7, Listeria, Campylobacter and Brucella -- that may cause illness and possibly death. Public health authorities, including FDA and the Centers for Disease Control and Prevention, have expressed concerns about the hazards of drinking raw milk for decades.
Symptoms of illness caused by various bacteria commonly found in raw milk may include vomiting, diarrhea, abdominal pain, fever, headache and body ache. Most healthy individuals recover quickly from illness caused by raw milk. However, some people may have more severe illness, and the harmful bacteria in raw milk can be especially dangerous for pregnant women, the elderly, infants, young children and people with weakened immune systems.
If consumers of raw milk are experiencing one or more of these symptoms after consuming raw milk or food products made from raw milk, they should contact their health care provider immediately.
Since 1987, the FDA has required all milk packaged for human consumption to be pasteurized before being delivered for introduction into interstate commerce. Pasteurization, a process that heats milk to a specific temperature for a set period of time, kills bacteria responsible for diseases, such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria and brucellosis. FDA’s pasteurization requirement also applies to other milk products, with the exception of a few aged cheeses.
From 1998 to 2008, 85 outbreaks of human infections resulting from consumption of raw milk were reported to CDC. These outbreaks included a total of 1,614 reported illnesses, 187 hospitalizations and 2 deaths. Because not all cases of foodborne illness are recognized and reported, the actual number of illnesses associated with raw milk likely is greater.
Proponents of drinking raw milk often claim that raw milk is more nutritious than pasteurized milk and that raw milk is inherently antimicrobial, thus making pasteurization unnecessary. There is no meaningful nutritional difference between pasteurized and raw milk, and raw milk does not contain compounds that will kill harmful bacteria.
Monday, March 8, 2010
Information for Food Manufacturers - Recall of Hydrolysed Vegetable Protein (HVP) by Basic Flavors Inc.
Information for Food Manufacturers - Recall of Hydrolysed Vegetable Protein (HVP) by Basic Flavors Inc., Las Vegas, Nevada
The Canadian Food Inspection Agency (CFIA) is providing this information to industry regarding the hydrolysed vegetable protein (HVP) made by Basic Food Flavors Inc. of Las Vegas, Nevada.
This ingredient is subject to recalls in the United States, has been imported into Canada and may be contaminated with Salmonella. The CFIA is working with its counterparts in the U.S. to determine the situation in Canada. To date, no illnesses have been associated with this recall, either in the U.S. or Canada. The Public Health Agency of Canada (PHAC) will continue to actively monitor for illnesses as recall activities continue.
This information is intended to facilitate industry assessment of the current situation and the determination of appropriate steps to mitigate the risk of exposure of consumers to Salmonella related to the use of HVP in product manufacture.
Background Information
The U.S. Food and Drug Administration (FDA) was informed of Salmonella contamination in HVP made by Basic Food Flavors Inc. of Las Vegas, Nevada. Further investigation identified Salmonella contamination in the manufacturing facility. On February 25, 2010, Basic Food Flavors Inc. issued a voluntary recall of all powder and paste HVP made since September 17, 2009.
The CFIA has determined that HVP from Basic Food Flavors is imported into Canada and may be used in the manufacture of a variety of foods.
HVP is an ingredient commonly used as a flavour enhancer or seasoning in many food products. In many cases, HVP is incorporated at low levels in processed foods which are made using processes that kill Salmonella. In addition, many foods that contain HVP are cooked by consumers in ways that would kill Salmonella. However, certain ready-to-eat foods which incorporate HVP can be produced using processes which would not destroy Salmonella and may therefore pose a risk to consumers if the recalled HVP has been used in their production.
Food contaminated with Salmonella may not look or smell spoiled. Consumption of food contaminated with these bacteria may cause salmonellosis, a foodborne illness. In young children, the elderly and people with weakened immune systems, salmonellosis may cause serious and sometimes deadly infections. In otherwise healthy people, salmonellosis may cause short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhoea. Long term complications may include severe arthritis.
Information for Manufacturers
Based on information available at this time, the CFIA is providing information on several risk-appropriate steps for recalled HVP or products containing recalled HVP made by Basic Food Flavors Inc. on or after September 17, 2009.
In general, the risk-appropriate steps can be divided into four categories:
1.Bulk HVP recalled by Basic Food Flavors Inc.
Canadian manufacturers who have unused HVP which has been recalled should stop using the product, unless it will be used in a finished product which involves a process which will kill Salmonella.
2.Ready-to-eat foods manufactured with recalled HVP.
These products may contain Salmonella and may be subject to a recall where the products have not been subjected to an adequate kill step for Salmonella.
3.Ready-to-cook foods manufactured with recalled HVP:
Cooking instructions on the product labels should be assessed to ensure they include an adequate kill step for Salmonella. If cooking / heating instructions are adequate to kill Salmonella, no action is required. If cooking instructions are not adequate, these products may need to be recalled.
4.Other potential uses
Industry should also consider how their product may be used by the consumer. For example, a powdered soup mix, when prepared according to instructions on the label which include an adequate kill step, may be considered safe. However, the same product may have recipe ideas on the label, or, is widely used by consumers to make a dip for chips without any kill step and is therefore considered ready-to-eat. If the recalled HVP has been incorporated, such products may be subject to recall.
If firms do not know, or do not have the expertise to know if their process includes a kill step they should engage an expert for advice. The CFIA does not provide a list of qualified experts, however, such specialists may often be found through industry associations, universities, etc. Please note that thermal processing times and temperatures will vary depending on the particular food.
If a manufacturer decides to voluntarily recall products, please contact the local CFIA office or the Area Recall Coordinator with details.
Area Recall Coordinator Contact Information
Ontario
416-665-5049
Atlantic
506-381-7683
Quebec
1-866-806-4115
BC and Yukon
604-978-1120
Manitoba
204-797 4501
Saskatchewan
306-529 0671
Alberta, NWT and Nunavut
403-661-7505
The Canadian Food Inspection Agency (CFIA) is providing this information to industry regarding the hydrolysed vegetable protein (HVP) made by Basic Food Flavors Inc. of Las Vegas, Nevada.
This ingredient is subject to recalls in the United States, has been imported into Canada and may be contaminated with Salmonella. The CFIA is working with its counterparts in the U.S. to determine the situation in Canada. To date, no illnesses have been associated with this recall, either in the U.S. or Canada. The Public Health Agency of Canada (PHAC) will continue to actively monitor for illnesses as recall activities continue.
This information is intended to facilitate industry assessment of the current situation and the determination of appropriate steps to mitigate the risk of exposure of consumers to Salmonella related to the use of HVP in product manufacture.
Background Information
The U.S. Food and Drug Administration (FDA) was informed of Salmonella contamination in HVP made by Basic Food Flavors Inc. of Las Vegas, Nevada. Further investigation identified Salmonella contamination in the manufacturing facility. On February 25, 2010, Basic Food Flavors Inc. issued a voluntary recall of all powder and paste HVP made since September 17, 2009.
The CFIA has determined that HVP from Basic Food Flavors is imported into Canada and may be used in the manufacture of a variety of foods.
HVP is an ingredient commonly used as a flavour enhancer or seasoning in many food products. In many cases, HVP is incorporated at low levels in processed foods which are made using processes that kill Salmonella. In addition, many foods that contain HVP are cooked by consumers in ways that would kill Salmonella. However, certain ready-to-eat foods which incorporate HVP can be produced using processes which would not destroy Salmonella and may therefore pose a risk to consumers if the recalled HVP has been used in their production.
Food contaminated with Salmonella may not look or smell spoiled. Consumption of food contaminated with these bacteria may cause salmonellosis, a foodborne illness. In young children, the elderly and people with weakened immune systems, salmonellosis may cause serious and sometimes deadly infections. In otherwise healthy people, salmonellosis may cause short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhoea. Long term complications may include severe arthritis.
Information for Manufacturers
Based on information available at this time, the CFIA is providing information on several risk-appropriate steps for recalled HVP or products containing recalled HVP made by Basic Food Flavors Inc. on or after September 17, 2009.
In general, the risk-appropriate steps can be divided into four categories:
1.Bulk HVP recalled by Basic Food Flavors Inc.
Canadian manufacturers who have unused HVP which has been recalled should stop using the product, unless it will be used in a finished product which involves a process which will kill Salmonella.
2.Ready-to-eat foods manufactured with recalled HVP.
These products may contain Salmonella and may be subject to a recall where the products have not been subjected to an adequate kill step for Salmonella.
3.Ready-to-cook foods manufactured with recalled HVP:
Cooking instructions on the product labels should be assessed to ensure they include an adequate kill step for Salmonella. If cooking / heating instructions are adequate to kill Salmonella, no action is required. If cooking instructions are not adequate, these products may need to be recalled.
4.Other potential uses
Industry should also consider how their product may be used by the consumer. For example, a powdered soup mix, when prepared according to instructions on the label which include an adequate kill step, may be considered safe. However, the same product may have recipe ideas on the label, or, is widely used by consumers to make a dip for chips without any kill step and is therefore considered ready-to-eat. If the recalled HVP has been incorporated, such products may be subject to recall.
If firms do not know, or do not have the expertise to know if their process includes a kill step they should engage an expert for advice. The CFIA does not provide a list of qualified experts, however, such specialists may often be found through industry associations, universities, etc. Please note that thermal processing times and temperatures will vary depending on the particular food.
If a manufacturer decides to voluntarily recall products, please contact the local CFIA office or the Area Recall Coordinator with details.
Area Recall Coordinator Contact Information
Ontario
416-665-5049
Atlantic
506-381-7683
Quebec
1-866-806-4115
BC and Yukon
604-978-1120
Manitoba
204-797 4501
Saskatchewan
306-529 0671
Alberta, NWT and Nunavut
403-661-7505
Thursday, February 18, 2010
Consumer agency tells industry to put safety first
WASHINGTON — One of the nation's top safety officials is delivering a stern warning to the makers of toys, cribs and other children's products, telling them to put safety first — or face potential fines, lawsuits or other actions.
"If you resist our efforts to recall children's products, be forewarned: This commission stands ready to be creative in the use of our enforcement authorities," Consumer Product Safety Commission Chairwoman Inez Tenenbaum said Wednesday.
It was her sharpest admonition to industry officials since taking over as chairman eight months ago. It follows pointed questions from Congress about the months-long lag time to tell the public about recalls of defective products.
In a speech to the International Consumer Product Health and Safety Organization, Tenenbaum said safety legislation passed in 2008 gives the commission new powers, "and we are not afraid to use them."
The product safety bill set strict limits on lead paint, lead and chemicals called phthalates that are used to soften plastics. It also called for new rules governing cribs, ATVs and other products.
At a crib safety hearing last month, House lawmakers wanted to know why it took CPSC more than six months to negotiate a record recall in November of more than 2 million Stork Craft drop-side cribs. The suffocation deaths of four infants were linked to the cribs.
Tenenbaum said at the time that CPSC and manufacturers need to investigate allegations of defects and then work together on the exact wording of the announcement to the public — a process that can take months. The alternative could be litigation, which might take even longer.
Several lawmakers appeared skeptical, but Tenenbaum pledged to renew efforts to hasten safety recalls.
On Wednesday, Tenenbaum also promised new safety rules for cribs, expected at the end of this year. Since 2007, about 7 million cribs have been recalled — cribs tied to a dozen deaths of infants.
The commission's mandatory standards governing cribs haven't been updated since 1982
"If you resist our efforts to recall children's products, be forewarned: This commission stands ready to be creative in the use of our enforcement authorities," Consumer Product Safety Commission Chairwoman Inez Tenenbaum said Wednesday.
It was her sharpest admonition to industry officials since taking over as chairman eight months ago. It follows pointed questions from Congress about the months-long lag time to tell the public about recalls of defective products.
In a speech to the International Consumer Product Health and Safety Organization, Tenenbaum said safety legislation passed in 2008 gives the commission new powers, "and we are not afraid to use them."
The product safety bill set strict limits on lead paint, lead and chemicals called phthalates that are used to soften plastics. It also called for new rules governing cribs, ATVs and other products.
At a crib safety hearing last month, House lawmakers wanted to know why it took CPSC more than six months to negotiate a record recall in November of more than 2 million Stork Craft drop-side cribs. The suffocation deaths of four infants were linked to the cribs.
Tenenbaum said at the time that CPSC and manufacturers need to investigate allegations of defects and then work together on the exact wording of the announcement to the public — a process that can take months. The alternative could be litigation, which might take even longer.
Several lawmakers appeared skeptical, but Tenenbaum pledged to renew efforts to hasten safety recalls.
On Wednesday, Tenenbaum also promised new safety rules for cribs, expected at the end of this year. Since 2007, about 7 million cribs have been recalled — cribs tied to a dozen deaths of infants.
The commission's mandatory standards governing cribs haven't been updated since 1982
FDA Urges Safe Use of Certain Inhaled Asthma Medicines
FDA Urges Safe Use of Certain Inhaled Asthma Medicine
The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.
On Feb. 18, 2010, the agency said
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.
LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)
The drugs affected by FDA's announcement include
the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)
How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.
Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.
FDA's recommendations only apply to the use of LABAs in the treatment of asthma.
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.
“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”
Additional Advice
In addition to following the recommendations issued on Feb. 18, FDA advises patients to
know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs
Other FDA Actions
On Feb. 18, FDA also required that the product labels for LABAs reflect the agency's recommendations
called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices
required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug
This article appears on FDA's Consumer Updates page1, which features the latest on all FDA-regulated products.
The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.
On Feb. 18, 2010, the agency said
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.
LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)
The drugs affected by FDA's announcement include
the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)
How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.
Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.
FDA's recommendations only apply to the use of LABAs in the treatment of asthma.
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.
“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”
Additional Advice
In addition to following the recommendations issued on Feb. 18, FDA advises patients to
know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs
Other FDA Actions
On Feb. 18, FDA also required that the product labels for LABAs reflect the agency's recommendations
called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices
required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug
This article appears on FDA's Consumer Updates page1, which features the latest on all FDA-regulated products.
Health Canada proposes LABELLING changes
Health Canada is launching a consultation with stakeholders and the Canadian public on proposed changes to improve the labelling requirements for food colours in Canada.
The consultation, which will be posted on the Health Canada website and open for comments from February 18th until May 4th, is intended to seek input on several options for future labelling requirements.
The Canadian Food and Drug Regulations currently allow manufacturers to use the general term “colour” to specify one or more food colours. For the majority of prepackaged foods, manufacturers may voluntarily declare individual colours by name at their own discretion.
However, there is some evidence suggesting a link between consumption of certain food colours and adverse reactions in sensitive individuals. More recently, certain food colour mixtures have been associated with behavioural effects in children. For these reasons, Health Canada considers it prudent to improve labelling requirements for food colours.
Health Canada's proposed changes would eliminate the option of using the general term "colour" and require that individual colours be identified on food ingredient labels for many, if not all, colours. By improving food colour labelling requirements, Health Canada's goal is to enable consumers to make more informed choices which could contribute to the reduction of adverse reactions.
Health Canada will continue to update Canadians on the progress of this issue once the consultation period has concluded. Please visit the Health Canada website for more information on the proposal to improve the food colour labelling requirements in Canada.
In addition, please visit Health Canada's Allergen Labelling Page for information on another recent Health Canada initiative to improve prepackaged food labels,
The consultation, which will be posted on the Health Canada website and open for comments from February 18th until May 4th, is intended to seek input on several options for future labelling requirements.
The Canadian Food and Drug Regulations currently allow manufacturers to use the general term “colour” to specify one or more food colours. For the majority of prepackaged foods, manufacturers may voluntarily declare individual colours by name at their own discretion.
However, there is some evidence suggesting a link between consumption of certain food colours and adverse reactions in sensitive individuals. More recently, certain food colour mixtures have been associated with behavioural effects in children. For these reasons, Health Canada considers it prudent to improve labelling requirements for food colours.
Health Canada's proposed changes would eliminate the option of using the general term "colour" and require that individual colours be identified on food ingredient labels for many, if not all, colours. By improving food colour labelling requirements, Health Canada's goal is to enable consumers to make more informed choices which could contribute to the reduction of adverse reactions.
Health Canada will continue to update Canadians on the progress of this issue once the consultation period has concluded. Please visit the Health Canada website for more information on the proposal to improve the food colour labelling requirements in Canada.
In addition, please visit Health Canada's Allergen Labelling Page for information on another recent Health Canada initiative to improve prepackaged food labels,
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