CPSC Urges Consumers to Replace Batteries in Smoke Alarms This Weekend
WASHINGTON, D. C. – Change your clocks. Replace your smoke alarm batteries. Both are important this weekend as Daylight Saving Time ends on Sunday, November 2.
While changing your clock can keep you on time for work on Monday, the U.S. Consumer Product Safety Commission (CPSC) advises consumers that putting fresh batteries in your smoke alarms can save your life.
In recent years, an estimated annual average of 378,700 fires, 2,740 deaths, 13,090 injuries and $5.6 billion in property losses associated with residential fires have been reported by fire departments.
“Smoke alarms save lives. That’s a fact,” said CPSC Acting Chairman Nancy Nord. “Working smoke alarms buy you valuable time to get out of your home when there’s a fire.”
CPSC urges consumers to install smoke alarms on every level of their home, outside sleeping areas, and inside each bedroom. To minimize nuisance alarms, install smoke alarms at least 10 feet from the stove and oven.
CPSC staff recommends installing both ionization and photoelectric type smoke alarms. Ionization type smoke alarms typically detect flaming fires more quickly, while photoelectric
type smoke alarms typically detect smoldering fires sooner.
In addition to replacing smoke alarm batteries, consumers should test their smoke alarms every month to make sure they are operating properly – and never disable a smoke alarm. Long life smoke alarms with 10-year batteries are also available to consumers.
Thursday, October 30, 2008
Wednesday, October 29, 2008
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.
Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.
Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.
Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.
For a copy of the Subcommittee Report, go to: http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.
Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H."The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option"
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.
Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.
Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.
Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.
For a copy of the Subcommittee Report, go to: http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.
Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H."The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option"
Tuesday, October 28, 2008
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
Action involves Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease.
Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis.
Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease.
Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart
Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading.
Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits.
The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
Action involves Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease.
Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis.
Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease.
Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart
Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading.
Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits.
The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
Friday, October 24, 2008
Soon-To-Be-Banned Plastic Toys Flooding the Market
Soon-To-Be-Banned Plastic Toys Flooding the Market
Toymakers mount 'fire sale' of phthalate-laden children's products
There was a festive feeling among consumer advocates when Congress passed legislation over the summer that outlaws the use of phthalates -- chemicals some fear may cause reproductive defects -- in toys. But ever-inventive toymakers have a holiday surprise: a flood of phthalate-ridden toys hitting stores just in time for holiday shopping.
The ban enacted by Congress doesn't take effect until Feb. 10, so toymakers and distributors have their elves working overtime to clear out their backlog of toys containing the chemical additives that make hard plastics more flexible.
Consumer advocates and some members of Congress are outraged that toymakers and retailers are rushing to sell the contaminated toys rather than destroy them. Congress never meant to "encourage fire sales in toy stores," Rep. Janice Schakowsky (D-Ill.) told The Wall Street Journal.
Full Story: http://www.consumeraffairs.com/news04/2008/10/plastic_toys_xmas.html
Toymakers mount 'fire sale' of phthalate-laden children's products
There was a festive feeling among consumer advocates when Congress passed legislation over the summer that outlaws the use of phthalates -- chemicals some fear may cause reproductive defects -- in toys. But ever-inventive toymakers have a holiday surprise: a flood of phthalate-ridden toys hitting stores just in time for holiday shopping.
The ban enacted by Congress doesn't take effect until Feb. 10, so toymakers and distributors have their elves working overtime to clear out their backlog of toys containing the chemical additives that make hard plastics more flexible.
Consumer advocates and some members of Congress are outraged that toymakers and retailers are rushing to sell the contaminated toys rather than destroy them. Congress never meant to "encourage fire sales in toy stores," Rep. Janice Schakowsky (D-Ill.) told The Wall Street Journal.
Full Story: http://www.consumeraffairs.com/news04/2008/10/plastic_toys_xmas.html
CPSC and Carter’s Advise Parents of Rashes Associated with Heat Transferred, or “Tag-less,” Labels
CPSC and Carter’s Advise Parents of Rashes Associated with Heat Transferred, or “Tag-less,” Labels
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and Carter’s, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter’s clothing with heat-transferred, or “tag-less,” labels.
This advisory applies to Carter’s Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.
The garments, which were made in various countries, were sold at Carter’s own retail stores and at department and national chain stores.
If your child develops a rash on the upper back after wearing garments that have a “tag-less” label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter’s website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter’s toll free at 1-888-282-4674 or by email at contactus@carters.com
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and Carter’s, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter’s clothing with heat-transferred, or “tag-less,” labels.
This advisory applies to Carter’s Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.
The garments, which were made in various countries, were sold at Carter’s own retail stores and at department and national chain stores.
If your child develops a rash on the upper back after wearing garments that have a “tag-less” label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter’s website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter’s toll free at 1-888-282-4674 or by email at contactus@carters.com
Wednesday, October 22, 2008
Using Over-the-Counter Cough and Cold Products in Children
Using Over-the-Counter Cough and Cold Products in Children
Tips for Parents and Caregivers
On Oct. 8, 2008, the Food and Drug Administration (FDA) released a statement that supports recent voluntary actions by many drug manufacturers regarding the use of nonprescription, over-the-counter (OTC) cough and cold products in children.
The voluntary actions announced by the Consumer Healthcare Products Association (CHPA) are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use. CHPA represents most of the manufacturers of these products.
Members of CHPA have volunteered to modify the product labels of OTC cough and cold medicines to state "do not use" in children under 4 years of age. (Many of the products currently state "do not use" in children under 2 years of age.) Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state "do not use" in children under 4 years of age, while others will instruct not to use in children under 2 years of age.
FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.
Recent FDA ActionsFDA has held two public meetings over the past year on the safe use of nonprescription OTC cough and cold medicines in children. The most recent meeting on Oct. 2, 2008, focused on labeling of these products. FDA issued a nationwide Public Health Advisory in January 2008 recommending that these products not be used in children under the age of 2 because of the risk of serious and potentially life-threatening side effects. FDA continues to reach out to other public health agencies, consumer and patient groups, drug manufacturers, CHPA, and the scientific community. As it obtains more up-to-date information and scientific data about the safety and effectiveness of these products in children, FDA can take the appropriate regulatory steps moving forward.
Tips for Parents and CaregiversDo not give children medications labeled only for adults. Talk to your health care professional, such as your doctor or pharmacist, if you have any questions about using cough or cold medicines in children. Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children. Check the "active ingredients" section of the "Drug Facts" label of the medicines that you choose. This section will help you understand what symptoms the active ingredients in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient, such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever and fever reducer. Be very careful if you are giving more than one medicine to a child. Make sure the medicines do not have the same type of active ingredients. For example, do not give a child more than one medicine that has a decongestant. If you use two medicines that have the same or similar active ingredients, your child could be harmed by getting too much of an ingredient. Carefully follow the directions for how to use the medicine in the "Drug Facts" part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or other health care professional. Overuse or misuse of these products can lead to serious and potentially life-threatening side effects, such as rapid heartbeat, drowsiness, breathing problems, and seizures. Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child's symptoms, such as runny nose, congestion, fever, and aches. They do not shorten the length of time your child is sick.
This article appears on FDA's Consumer Health Information Web page
(www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More InformationSafe Use of Over-the-Counter Drug
Productswww.fda.gov/cder/offices/otc/consumer.htm
FDA 101: How to Use the Consumer Complaint System and MedWatchwww.fda.gov/consumer/updates/reporting061008.html
Your Guide to Reporting Problems to FDAwww.fda.gov/consumer/updates/reporting_guide061008.html
Improving Medical Products for Children: Q & A with Dianne Murphy, M.D.www.fda.gov/consumer/updates/murphy091407.html
Tips for Parents and Caregivers
On Oct. 8, 2008, the Food and Drug Administration (FDA) released a statement that supports recent voluntary actions by many drug manufacturers regarding the use of nonprescription, over-the-counter (OTC) cough and cold products in children.
The voluntary actions announced by the Consumer Healthcare Products Association (CHPA) are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use. CHPA represents most of the manufacturers of these products.
Members of CHPA have volunteered to modify the product labels of OTC cough and cold medicines to state "do not use" in children under 4 years of age. (Many of the products currently state "do not use" in children under 2 years of age.) Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state "do not use" in children under 4 years of age, while others will instruct not to use in children under 2 years of age.
FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.
Recent FDA ActionsFDA has held two public meetings over the past year on the safe use of nonprescription OTC cough and cold medicines in children. The most recent meeting on Oct. 2, 2008, focused on labeling of these products. FDA issued a nationwide Public Health Advisory in January 2008 recommending that these products not be used in children under the age of 2 because of the risk of serious and potentially life-threatening side effects. FDA continues to reach out to other public health agencies, consumer and patient groups, drug manufacturers, CHPA, and the scientific community. As it obtains more up-to-date information and scientific data about the safety and effectiveness of these products in children, FDA can take the appropriate regulatory steps moving forward.
Tips for Parents and CaregiversDo not give children medications labeled only for adults. Talk to your health care professional, such as your doctor or pharmacist, if you have any questions about using cough or cold medicines in children. Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children. Check the "active ingredients" section of the "Drug Facts" label of the medicines that you choose. This section will help you understand what symptoms the active ingredients in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient, such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever and fever reducer. Be very careful if you are giving more than one medicine to a child. Make sure the medicines do not have the same type of active ingredients. For example, do not give a child more than one medicine that has a decongestant. If you use two medicines that have the same or similar active ingredients, your child could be harmed by getting too much of an ingredient. Carefully follow the directions for how to use the medicine in the "Drug Facts" part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or other health care professional. Overuse or misuse of these products can lead to serious and potentially life-threatening side effects, such as rapid heartbeat, drowsiness, breathing problems, and seizures. Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child's symptoms, such as runny nose, congestion, fever, and aches. They do not shorten the length of time your child is sick.
This article appears on FDA's Consumer Health Information Web page
(www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More InformationSafe Use of Over-the-Counter Drug
Productswww.fda.gov/cder/offices/otc/consumer.htm
FDA 101: How to Use the Consumer Complaint System and MedWatchwww.fda.gov/consumer/updates/reporting061008.html
Your Guide to Reporting Problems to FDAwww.fda.gov/consumer/updates/reporting_guide061008.html
Improving Medical Products for Children: Q & A with Dianne Murphy, M.D.www.fda.gov/consumer/updates/murphy091407.html
Sunday, October 19, 2008
States Act On BPA in Baby Bottles
States Act On BPA in Baby Bottles
Regulators take harder stance on chemical than Federal counterparts While federal regulators have taken the position that the chemical bisphenol A (BPA) in consumer products like baby bottles poses no risk, three states are taking a harder line.
Officials in Connecticut, New Jersey and Deleware have sent letters to 11 manufacturers, asking them to stop using BPA in baby bottles and baby formula containers in light of recent studies clearly linking the chemical to potential health problems.
The states contend that growing scientific evidence shows that even small amounts of BPA damages infant reproductive, neurological and immune systems.
"Exposure to this dangerous chemical has been linked to a range of illnesses, including cancer and diabetes. For the sake of consumers' safety, and especially the health and safety of our children, we are calling on manufacturers to immediately remove this chemical from the products they produce," said Delaware State Solicitor Lawrence Lewis.
Full Story: http://www.consumeraffairs.com/news04/2008/10/bpa_states.html
Regulators take harder stance on chemical than Federal counterparts While federal regulators have taken the position that the chemical bisphenol A (BPA) in consumer products like baby bottles poses no risk, three states are taking a harder line.
Officials in Connecticut, New Jersey and Deleware have sent letters to 11 manufacturers, asking them to stop using BPA in baby bottles and baby formula containers in light of recent studies clearly linking the chemical to potential health problems.
The states contend that growing scientific evidence shows that even small amounts of BPA damages infant reproductive, neurological and immune systems.
"Exposure to this dangerous chemical has been linked to a range of illnesses, including cancer and diabetes. For the sake of consumers' safety, and especially the health and safety of our children, we are calling on manufacturers to immediately remove this chemical from the products they produce," said Delaware State Solicitor Lawrence Lewis.
Full Story: http://www.consumeraffairs.com/news04/2008/10/bpa_states.html
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