1. Children's Metal Jewelry Recalled by TOBY N.Y.C. Due to Risk of LeadExposure
2. Children's Charm Bracelets Sold by Buy-Rite Recalled Due to Risk ofLead Exposure
3. Thomas and Friends, Curious George and Other Spinning Tops and TinPails Recalled By Schylling Associates Due To Violation of Lead PaintStandard
4. Martin Designs Inc. Recalls SpongeBob SquarePants(tm) CharacterAddress Books and Journals Due to Violation of Lead Paint Standard
Children's Metal Jewelry Recalled by TOBY N.Y.C. Due to Risk of Lead Exposure
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: TOBY & ME Jewelry Sets
Units: About 14,000
Importer: TOBY N.Y.C., of New York, N.Y.
Hazard: The recalled metal jewelry sets contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.
Incidents/Injuries: None reported.
Description: The three recalled jewelry sets include: a princess pink and clear crystal bead necklace and bracelet set with a painted metallic crown pendant; a pink and white pearl necklace and bracelet set with a painted metallic poodle pendant; and a pink pearl necklace, earrings and ring set. All sets are sold in a pink gift box with "TOBY & ME" printed on the front and "TOBY & ME" hang tags attached to the packaging.
Sold at: T.J. Maxx, Marshalls, and A.J.Wright from August 2006 through May 2007 for about $8.
Manufactured in: China
Remedy: Consumers should immediately take the recalled jewelry away from children and contact TOBY N.Y.C. for information on receiving a full refund or replacement item.
Consumer Contact: For additional information, contact TOBY N.Y.C.toll-free at (866) 235-0588 between 9 a.m. and 5 p.m. ET Monday through Friday, or email the firm at info@tobynyc.com
Children's Charm Bracelets Sold by Buy-Rite Recalled Due to Risk of LeadExposure
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Children's Divine Inspiration Charm Bracelets
Units: About 7,900 Importer: Buy-Rite Designs Inc., of Freehold, N.J.
Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.
Incidents/Injuries: None reported.
Description: The recalled charm bracelets have silver-colored charms, including angels, crosses, and hearts, and clear and pink beads that hang from a silver-colored chain.
Sold at: Dollar stores and other small retail stores nationwide from March 2004 through August 2007 for about $1.
Manufactured in: China
Remedy: Consumers should immediately take the recalled jewelry away from children and return it to store where purchased for a full refund. If unable to return it to the store, contact Buy-Rite for information onhow to receive a refund.
Consumer Contact: For additional information, contact Buy-Rite at (888) 777-7952 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.buyriteinc.com
Thomas and Friends, Curious George and Other Spinning Tops and Tin Pails
Recalled By Schylling Associates Due To Violation of Lead Paint Standard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, incooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Spinning Tops and Tin Pails
Units: About 66,000 spinning tops and about 4,700 pails
Importer: Schylling Associates Inc., of Rowley, Mass.
Hazard: Surface paints on the wooden handles of the tops and pails contain excessive levels of lead, which violates the federal lead paint standard. Lead is toxic if ingested by young children and can cause adverse health effects.
Incidents/Injuries: None.
Description: The recalled tops and pails are primarily metal and have wooden handles. The tops are painted with Thomas and Friends, Curious George, or a circus scene. The pails are painted with Thomas and Friends, Curious George, or in a solid red or yellow color. Tops with plastic handles are not included in this recall.
Sold at: Specialty toy stores and gift shops nationwide from July 2001 through July 2002. The tops were sold for about $13. The pails were soldf or about $6.
Manufactured in: China
Remedy: Consumers should immediately take the recalled toys away from children and contact Schylling to receive a refund or free replacementtoy.
Consumer Contact: For additional information, contact Schylling at (800) 767-8697 between 9 am and 5 pm ET Monday through Friday, or visit the firm's Web site at www.schylling.com
Martin Designs Inc. Recalls SpongeBob SquarePants(tm) Character Address Books and Journals Due to Violation of Lead Paint Standard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: SpongeBob SquarePants(tm) Address Books and Journals Units: About 250,000
Importer: Martin Designs Inc., of Ashland, Ohio
Hazard: The paint on the metal spiral bindings of the address books and journals can contain excessive levels of lead, which violates the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health effects.
Incidents/Injuries: None.
Description: The recall involves address books and journals with SpongeBob SquarePants(tm) character on the front cover and a black metal spiral binding. The UPC numbers (80773007505 for the address book and 80773002260 for the journal) are printed on the back covers.
Sold at: Retail stores nationwide from June 2006 through July 2007 for about $2.
Manufactured in: China
Remedy: Consumers should immediately take the recalled address books and journals away from children. Consumers should remove the UPC as proof of ownership and contact Martin Designs Inc. for a full refund.
Consumer Contact: For additional information, contact Martin Designs Inc. toll-free at (866) 898-0261 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site atwww.martindesigns-ltd.com
Wednesday, August 22, 2007
Select Krasdale Gravy Dry Dog Food 5lb Bags Voluntarily Recalled in Five States
August 21, 2007 -- Mars Petcare US, Inc. today announces a voluntary recall of select five pound bags of Krasdale Gravy dry dog food sold in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania. The pet food is being recalled because it has the potential to be contaminated with Salmonella, which can cause serious infections in dogs and cats, and, if there is cross contamination, in people, especially children, the aged, and people with compromised immune systems.
The recalled product should not be sold or fed to pets. Pet owners should dispose of product in a safe manner (example, a securely covered trash receptacle) and return the empty bag to the store where purchased for a full refund.
Salmonella can potentially be transferred to people handling this pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Recalled pet food Product: Krasdale Gravy dry dog food
Size: 5 pound bag
UPC Code: 7513062596
Best Buy Date: July 16 & 17, 2008
Best Buy Date Location: Back of bag
Affected Stores: Various stores located in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania.
Mars Petcare is issuing this action out of an abundance of caution and it sincerely regrets any inconvenience to pet owners as a result of this announcement. This voluntary recall has been issued because the FDA detected Salmonella in a sample of Krasdale Gravy dry dog food with best buy dates of July 16 & 17, 2008 during a recent review.
In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at: www.fda.gov/consumer/updates/petfoodtips080307.html
This product UPC has been blocked from retail sale at these locations.
Additional information about the product is available on www.marspetcare.com. Pet owners who have questions about the voluntary recall should call (866) 298-8332, or visit the web site for more information.
The recalled product should not be sold or fed to pets. Pet owners should dispose of product in a safe manner (example, a securely covered trash receptacle) and return the empty bag to the store where purchased for a full refund.
Salmonella can potentially be transferred to people handling this pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Recalled pet food Product: Krasdale Gravy dry dog food
Size: 5 pound bag
UPC Code: 7513062596
Best Buy Date: July 16 & 17, 2008
Best Buy Date Location: Back of bag
Affected Stores: Various stores located in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania.
Mars Petcare is issuing this action out of an abundance of caution and it sincerely regrets any inconvenience to pet owners as a result of this announcement. This voluntary recall has been issued because the FDA detected Salmonella in a sample of Krasdale Gravy dry dog food with best buy dates of July 16 & 17, 2008 during a recent review.
In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at: www.fda.gov/consumer/updates/petfoodtips080307.html
This product UPC has been blocked from retail sale at these locations.
Additional information about the product is available on www.marspetcare.com. Pet owners who have questions about the voluntary recall should call (866) 298-8332, or visit the web site for more information.
Tuesday, August 21, 2007
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
Companies Will Include Boxed Warning on Drug Label
The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a “boxed” warning—FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda, to address these concerns.
“Under FDA’s postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.”
FDA’s review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.
The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
FDA’s review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
For more information, visit:
http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
http://www.fda.gov/cder/drug/infopage/pioglitazone/default.htm
The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a “boxed” warning—FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda, to address these concerns.
“Under FDA’s postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.”
FDA’s review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.
The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
FDA’s review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
For more information, visit:
http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
http://www.fda.gov/cder/drug/infopage/pioglitazone/default.htm
Clarion Expands Recall of Vehicle Navigation and Entertainment System Batteries Due to Burn and Fire Hazards
The U.S. Consumer Product Safety Commission, incooperation with the firm named below, today announced a voluntaryrecall of the following consumer product.
Consumers should stop usingrecalled products immediately unless otherwise instructed. Name of Product: N.I.C.E. P200 Navigation and Entertainment Systems
Units: About 1,500 additional units (about 2,500 were recalled inDecember 2006)
Distributor: Clarion Corp. of America, of Cypress, Calif.
Manufacturer: Kiryung Electronics of Seoul, South Korea
Hazard: The lithium-ion batteries in these units can melt or overheatposing burn and fire hazards to consumers.
Incidents/Injuries: Clarion has received 15 reports of the units meltingor overheating. No injuries have been reported. Description: The N.I.C.E. P200 is a black portable navigation andentertainment device that can be attached to a vehicle's windshield. Thedevice has a 4-inch touch screen LCD monitor and contains one lithiumbattery.
"Clarion" and "N.I.C.E. P200" are printed on the device."Clarion NAVBATTERY" is printed on the battery. The recall includes anyN.I.C.E. P200 in which batteries were previously replaced. Sold at: Car audio and mobile electronics stores nationwide from May2006 through August 2007 for a suggested retail price of $800.
Manufactured in: South Korea Remedy: Consumers should stop using the recalled batteries immediatelyand contact Clarion Corp. for a full refund, information on returningthe product, and a postage paid envelope to return the product.
Consumer Contact: For more information, contact Clarion Corp. at (800)347-8667 Monday through Friday between 9 a.m. and 5 p.m. PT, email parts@clarion.com, or visit the firm's Web site at www.clarion.com
The U.S. Consumer Product Safety Commission is charged with protectingthe public from unreasonable risks of serious injury or death from morethan 15,000 types of consumer products under the agency's jurisdiction.Deaths, injuries and property damage from consumer product incidentscost the nation more than $700 billion annually. The CPSC is committedto protecting consumers and families from products that pose a fire,electrical, chemical, or mechanical hazard or can injure children. TheCPSC's work to ensure the safety of consumer products - such as toys,cribs, power tools, cigarette lighters, and household chemicals -contributed significantly to the 30 percent decline in the rate ofdeaths and injuries associated with consumer products over the past 30years.
To report a dangerous product or a product-related injury, call CPSC'shotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270, orvisit CPSC's web site at www.cpsc.gov/talk.html. To join a CPSC emailsubscription list, please go to www.cpsc.gov/cpsclist.aspx. Consumerscan obtain this release and recall information at CPSC's Web site atwww.cpsc.gov.
Consumers should stop usingrecalled products immediately unless otherwise instructed. Name of Product: N.I.C.E. P200 Navigation and Entertainment Systems
Units: About 1,500 additional units (about 2,500 were recalled inDecember 2006)
Distributor: Clarion Corp. of America, of Cypress, Calif.
Manufacturer: Kiryung Electronics of Seoul, South Korea
Hazard: The lithium-ion batteries in these units can melt or overheatposing burn and fire hazards to consumers.
Incidents/Injuries: Clarion has received 15 reports of the units meltingor overheating. No injuries have been reported. Description: The N.I.C.E. P200 is a black portable navigation andentertainment device that can be attached to a vehicle's windshield. Thedevice has a 4-inch touch screen LCD monitor and contains one lithiumbattery.
"Clarion" and "N.I.C.E. P200" are printed on the device."Clarion NAVBATTERY" is printed on the battery. The recall includes anyN.I.C.E. P200 in which batteries were previously replaced. Sold at: Car audio and mobile electronics stores nationwide from May2006 through August 2007 for a suggested retail price of $800.
Manufactured in: South Korea Remedy: Consumers should stop using the recalled batteries immediatelyand contact Clarion Corp. for a full refund, information on returningthe product, and a postage paid envelope to return the product.
Consumer Contact: For more information, contact Clarion Corp. at (800)347-8667 Monday through Friday between 9 a.m. and 5 p.m. PT, email parts@clarion.com, or visit the firm's Web site at www.clarion.com
The U.S. Consumer Product Safety Commission is charged with protectingthe public from unreasonable risks of serious injury or death from morethan 15,000 types of consumer products under the agency's jurisdiction.Deaths, injuries and property damage from consumer product incidentscost the nation more than $700 billion annually. The CPSC is committedto protecting consumers and families from products that pose a fire,electrical, chemical, or mechanical hazard or can injure children. TheCPSC's work to ensure the safety of consumer products - such as toys,cribs, power tools, cigarette lighters, and household chemicals -contributed significantly to the 30 percent decline in the rate ofdeaths and injuries associated with consumer products over the past 30years.
To report a dangerous product or a product-related injury, call CPSC'shotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270, orvisit CPSC's web site at www.cpsc.gov/talk.html. To join a CPSC emailsubscription list, please go to www.cpsc.gov/cpsclist.aspx. Consumerscan obtain this release and recall information at CPSC's Web site atwww.cpsc.gov.
Ocean King Enterprises Inc. Recalls the Following Ready-To-Eat Seafood Dips Because of Possible Health Risk
Regal King Premium Krab Dip
Regal King Cajun Krab Dip
Regal King Shrimp Dip
Regal King Smoked Salmon Dip
Contact:Ocean King Enterprises Inc. (215) 495-0540
FOR IMMEDIATE RELEASE -- Philadelphia, PA -- August 16, 2007 -- Ocean King Enterprises Inc. of Philadelphia, PA is recalling Ready-to-Eat Seafood Dips, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Products were distributed through the following A&P warehouses: A&P (C&S) Hatfield in Hatfield, MA; A&P (C&S) Baltimore in North East, MD; and A&P (C&S) Woodbridge in Woodbridge, NJ. Products will have reached consumers through retail stores from warehouse distribution.
The products were sold in bulk 5-pound containers to the warehouses. The dips are then sold in the value added and deli sections of the retail stores in clear plastic containers with a Regal King label. All flavors have a red and white repack label. The brand name is Regal King Gourmet Seafood. The flavors are Premium Krab Dip, Cajun Krab Dip, Shrimp Dip, and Smoked Salmon Dip.
No illnesses have been reported to date.
The recall was the result of an independent systemic sampling program conducted by Ocean King Enterprises Inc. which revealed that one finished product contained the bacteria. The company has ceased the production and distribution of the product as FDA and Ocean King Enterprises continue their investigation as to what caused the problem.
Consumers who purchased Regal King Brand ready-to-eat seafood dips should return the product to the store for a full refund. Consumers with questions may contact Ocean King Enterprises Inc. at (215) 495-0540.
Regal King Cajun Krab Dip
Regal King Shrimp Dip
Regal King Smoked Salmon Dip
Contact:Ocean King Enterprises Inc. (215) 495-0540
FOR IMMEDIATE RELEASE -- Philadelphia, PA -- August 16, 2007 -- Ocean King Enterprises Inc. of Philadelphia, PA is recalling Ready-to-Eat Seafood Dips, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Products were distributed through the following A&P warehouses: A&P (C&S) Hatfield in Hatfield, MA; A&P (C&S) Baltimore in North East, MD; and A&P (C&S) Woodbridge in Woodbridge, NJ. Products will have reached consumers through retail stores from warehouse distribution.
The products were sold in bulk 5-pound containers to the warehouses. The dips are then sold in the value added and deli sections of the retail stores in clear plastic containers with a Regal King label. All flavors have a red and white repack label. The brand name is Regal King Gourmet Seafood. The flavors are Premium Krab Dip, Cajun Krab Dip, Shrimp Dip, and Smoked Salmon Dip.
No illnesses have been reported to date.
The recall was the result of an independent systemic sampling program conducted by Ocean King Enterprises Inc. which revealed that one finished product contained the bacteria. The company has ceased the production and distribution of the product as FDA and Ocean King Enterprises continue their investigation as to what caused the problem.
Consumers who purchased Regal King Brand ready-to-eat seafood dips should return the product to the store for a full refund. Consumers with questions may contact Ocean King Enterprises Inc. at (215) 495-0540.
FDA Warning on Codeine Use by Nursing Mothers
May Increase Chance of Serious Side Effects in Infants
The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother’s milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showed that the mother was an ultra-rapid metabolizer of codeine.
"Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. "And nursing mothers should always consult their physicians before taking any codeine containing products."
Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.
According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.
Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother’s breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor’s judgment.
Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.
For more information, go to Use of Codeine Products in Nursing Mothers
The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother’s milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showed that the mother was an ultra-rapid metabolizer of codeine.
"Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. "And nursing mothers should always consult their physicians before taking any codeine containing products."
Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.
According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.
Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother’s breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor’s judgment.
Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.
For more information, go to Use of Codeine Products in Nursing Mothers
Confidence Inc. Issues a Voluntary Nationwide Recall in the United States and Canada of One Lot of METABOSLIM Apple Cider Vinegar brand dietary supple
Confidence Inc. of Port Washington, NY, is recalling one lot of METABOSLIMTM Apple Cider Vinegar brand dietary supplement, lot number 3001006, EXP. 102009 and UPC CODE: 92483 00102 because it contains the undeclared drug ingredient sibutramine. This lot was primarily sold in Canada. The product is sold in a plastic bottle with white and red labeling and contains 60 gelatin capsules.
The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of METABOSLIMTM samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOSLIMTM as a drug; therefore the safety and effectiveness of this product is unknown.
FDA advises that this poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product.
Confidence, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Confidence Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers should return any unused METABOSLIMTM for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email jim@confidenceusa.com to receive further instructions for returning the product or with any questions.
The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of METABOSLIMTM samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOSLIMTM as a drug; therefore the safety and effectiveness of this product is unknown.
FDA advises that this poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product.
Confidence, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Confidence Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers should return any unused METABOSLIMTM for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email jim@confidenceusa.com to receive further instructions for returning the product or with any questions.
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