Bella Cucina of Atlanta, Georgia is recalling units of Death by Chocolate cookies if your bag does not correctly state that the product contains walnuts. People who have an allergy or severe sensitivity to Walnuts run the risk of serious or life threatening allergic reaction if they consume these products.
Death by Chocolate cookies may have been sold directly to consumers in the following retail stores:
Store
Contact Information
Ballins, LTD
Wendy Legarde550 Elmwood Park BlvdSuite BHarahan, LA 70123
At Home Store
At Home StoreRosie Witherspoon52 N. Main StFairfield, IA 52556
Perfect Package
Perfect PackageAttn:Robin263 Park AveWorcester, MA 1609USA
Lincoln Finishing Touches-NE
Lincoln Finishing Touches-NEAttn: Linda Spurrier3945 S. 48tLincoln, NE 68506USA
Farm Fresh To You Store
Farm Fresh To You StoreFreeman O Barsotti1 Ferry BuildingShop 9San Francisco, CA 94105
The Fig Pantry
The Fig Pantry (bill)Attn: Jennifer21800 Schellville RdSuite CSonoma, CA 95476USA
Black Salt
Black Saltc/o:Scott Weinstein-Fish Marke4883 MacArthur Blvd NWWashington, DC 20007
Great American
Great AmericanAttn: Amy Hamilton-Hails4121 16th Street N.St Petersberg, FL 33703
Kiawah Island Resort
Osprey PointAttn: Ashley Agapion Magee700 Governors Dr.Kiawah Island, SC 29455
Trapp & Co
Trapp & Co.Attn: Helga/Steven4110 Main StreetKansas City, MO 64111US
Joli Home and Events
Joli Home & EventsCheryl Hunter8B MarketBeaufort, SC 29906
James Welch
James WelchJames Welch260 Balfour DriveWinter Park, FL 32792
Crabby Chic
Crabby ChicAttn: Pam Teebo4407 Cascade RdWilmington, NC 28409
McArdles Forest and Garden Center
McArdle's Forest & Garden CtrAttn :Sari48 Arch StreetGreenwich, CT 6830
BCAF Grand Central Station
Bella Cucina Artful Food - GCS1870 Murphy AvenueAtlanta, GA 30310
Wines of Distinction, Inc.
Wines of Distinction, Inc.Attn: Katherine Rose230 E Main StAbingdon, VA 24210USA
Domaine Carneros
Domaine CarnerosAttn:Rose1240 Duhig RoadNapa, CA 94559
Build a Basket
Build A BasketAttn: Mena F/Scott Maybaum32 Rte 10 WestEast Hanover, NJ 07936USA
Design Line Interiors
Design Line InteriorsAttn:Connie4863 Shawline StreetSte. ESan Diego, CA 92111USA
BCAF Virginia Highlands
BCAF-Virginia Highlands1050 North Highland AvenueAtlanta, GA 30306
Nest
NestAttn: Mary Matheson4699 South Hollady BlvdSalt Lake City, UT 84117
Counrty Store - CA
Country Store -CAAttn:Carol L Holmes2408 W. Adrian StreetNewberry, CA 91320
Graeagle Gift Shop
NO CONTACT
Moravian Florist
Moravian FloristAttn: Sue Kirchhoffer2286 Richmond Rd.Staten Island, NY 10306USA
The Cheshire Cat
The Cheshire CatScott Comstock34121 N. Rt 45Grayslake, IL 60030
Kimball Shop
Kimball ShopNancey Kimball135 Main St. NEHarbor,ME 04662USA
Sayville General Store Inc
Sayville General Store, IncAttn: Jackie44 Main StreetSayville, NY 11782
Chintz & Company
Chintz & CompanyAttn: Nicole de Goutiere1720 Store StVictoria, BC V8W 1V5Canada
English Green Interiors
English Green InteriorsAttn: Deborah GreenP. O BOx 2541Cashiers, NC 28717
Bella Donna Designs
Bella Donna DesignsAttn:Donna131 Hurst CirFranklin, NC 28734
Equipment Di Vin
Equipment Di VinCheryl Webster1412 Larimer StreetDenver, CO 80202
Celebrations - FL
Celebrations-FLAttn: Debbie717 N. 12th Ave.Pensacola, FL 32501
French's Kitchen & Bath
French's Kitchen & Bath202 5th StHollister, CA 95023USA
Fanciful Gift Baskets
Fanciful Gift BasketsAttn: Dave5617 MelroseLos Angeles, CA 90038
Harris & Clark General Store
Harris & Clark General StoreAnissa Harris2539 Knox StAtlanta, Georgia 30317
Breckenridge Cheese and Chocolate
Breckenridge Cheese & ChocolateAttn: AnneP.O. Box 3771Breckenridge, CO 80424USA
Son of Moon Fine Foods
Son of the MoonEva Bunnell346 South Main St.Middletown, CT 06457USA
Roche Bros Supermarket
Roche Bros. #101165 Linden StreetWellesley Hill, MA 02481
Tenzie & Co
Tenzie & Co.1116-A Coolidge StreetLafayette, LA 70503USA
Pine Away
Pine Away216 Main St.Annapolis, MD 21401USA
Bee Entertaining
Bee Entertaining124 S. Webster StNaperville, IL 60540USA
The country Farmer
The Country Farmer1 Bloomer RdN. Salem, NY 10560
All stores have been notified of the incident.
The Death by Chocolate cookies is bags are in a 6oz. bag with a sleeve label. The UPC code for this product is 19193 00020. These cookies have a three month shelf life. The cookies being recalled were made on June 14, 2007 and also July 5, 2007 for a total of 36 cases, 12 units per case. The cookie ingredient list did not contain Walnuts.
No Illness have been reported to date.
Consumers should contact Bella Cucina directly at 678.539.8400 so we can refund or replace the cookie bag.
Thursday, August 30, 2007
Gerber Legendary Blades Recalls Pocket Knives
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: Gerber EAB (Exchange-A-Blade)
Pocket Knives Units: About 154,000
Importer: Gerber Legendary Blades, of Portland, Ore., a division of Fiskars Brands Inc., of Madison, Wis
Hazard: During use, the back of the blade of the knife can slide past the blade support, posing a laceration hazard to consumers.
Incidents/Injuries: Gerber has received eight reports of individuals cutting themselves while using the knife, including several individuals who required stitches.
Description: The recall involves Gerber EAB Pocket Knives, model numbers 22-41548, 22-41548CDIP, 22-01548W and 22-41548W. The knives are small, folding utility knives that can be clipped to the owner's pocket. The knives are marked with the "Gerber" trademark.
Sold at: Retail stores nationwide, including Wal-Mart, and through on-line stores from September 2006 through August 2007 for about $11.
Manufactured in: China
Remedy: Consumers should stop using the recalled knives immediately and contact Gerber to receive instructions on how to return the knife for a free replacement knife.
Consumer Contact: For more information, contact Gerber Legendary Blades toll-free at (877) 204-5510 between 9 a.m. and 5 p.m. PT, Monday through Friday or visit the firm's Web site at www.gerbergear.com
Name of Product: Gerber EAB (Exchange-A-Blade)
Pocket Knives Units: About 154,000
Importer: Gerber Legendary Blades, of Portland, Ore., a division of Fiskars Brands Inc., of Madison, Wis
Hazard: During use, the back of the blade of the knife can slide past the blade support, posing a laceration hazard to consumers.
Incidents/Injuries: Gerber has received eight reports of individuals cutting themselves while using the knife, including several individuals who required stitches.
Description: The recall involves Gerber EAB Pocket Knives, model numbers 22-41548, 22-41548CDIP, 22-01548W and 22-41548W. The knives are small, folding utility knives that can be clipped to the owner's pocket. The knives are marked with the "Gerber" trademark.
Sold at: Retail stores nationwide, including Wal-Mart, and through on-line stores from September 2006 through August 2007 for about $11.
Manufactured in: China
Remedy: Consumers should stop using the recalled knives immediately and contact Gerber to receive instructions on how to return the knife for a free replacement knife.
Consumer Contact: For more information, contact Gerber Legendary Blades toll-free at (877) 204-5510 between 9 a.m. and 5 p.m. PT, Monday through Friday or visit the firm's Web site at www.gerbergear.com
Paramount Apparel International Recalls Youth Hats Due to Strangulation Hazard; Product Sold Exclusively at Bass Pro Shops
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: Toddler and Youth Nylon Bucket Hats
Units: About 500
Distributor: Paramount Apparel International Inc., of Bourbon, Mo.
Hazard: The hat has a drawstring, posing a strangulation hazard to young children.
Incidents/Injuries: No incidents or injuries have been reported.
Description: The hat is a nylon bucket-shaped hat with mesh sides. There are nylon fabric strips on the side of the hat that snap up. The front of the hat has a zipper pocket with a silver boat-anchor appliqué with embroidered text below. The hat adjusts with a bungee drawstring sewn in the crown of the hat. A label sewn into the back inside of the hat reads "Bass Pro Shops."
Sold: Exclusively at Bass Pro Shops retail stores nationwide from February 2007 through June 2007 for about $8.
Manufactured in: China
Remedy: Consumers should stop using the recalled hats immediately and contact Paramount Apparel to receive a refund or replacement item.
Consumer Contact: For more information, contact Paramount Apparel toll-free at (800) 255-4287 between 7:30 a.m. and 4 p.m. CT Monday through Friday or visit the firm's Web site at www.paramountapparel.com
Name of Product: Toddler and Youth Nylon Bucket Hats
Units: About 500
Distributor: Paramount Apparel International Inc., of Bourbon, Mo.
Hazard: The hat has a drawstring, posing a strangulation hazard to young children.
Incidents/Injuries: No incidents or injuries have been reported.
Description: The hat is a nylon bucket-shaped hat with mesh sides. There are nylon fabric strips on the side of the hat that snap up. The front of the hat has a zipper pocket with a silver boat-anchor appliqué with embroidered text below. The hat adjusts with a bungee drawstring sewn in the crown of the hat. A label sewn into the back inside of the hat reads "Bass Pro Shops."
Sold: Exclusively at Bass Pro Shops retail stores nationwide from February 2007 through June 2007 for about $8.
Manufactured in: China
Remedy: Consumers should stop using the recalled hats immediately and contact Paramount Apparel to receive a refund or replacement item.
Consumer Contact: For more information, contact Paramount Apparel toll-free at (800) 255-4287 between 7:30 a.m. and 4 p.m. CT Monday through Friday or visit the firm's Web site at www.paramountapparel.com
M&J Engineering Recalls Swivels for Scuba Diving Masks Due to Drowning Hazard
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: AGA Swivels for Scuba Diving Masks
Units: About 1,500
Manufacturer: M&J Engineering, of Poway, Calif.
Hazard: The swivel, which is attached to a diving mask, could separate while diving. This will result in a sudden loss of the diver's air supply, causing the diver to engage in emergency ascent. This poses a risk of decompression sickness due to rapid ascent or drowning.
Incidents/Injuries: M&J Engineering has received one report of swivels separating from the masks while diving. No injuries have been reported.
Description: This recall involves all SW-3000 2nd stage 360-degree swivels for scuba diving masks manufactured between January 2004 and February 2005. The swivel has the date stamped on its body, below the patent number. Swivels that are already repaired have an arrow stamped on the top right corner of the swivel body.
Sold at: Diving retail stores nationwide between January 2004 and February 2005 for about $60.
Manufactured in: USA
Remedy: Consumers should immediately stop using the scuba diving masks with the swivel attached and contact M&J Engineering to receive a free repair.
Consumer Contact: For additional information, contact M&J Engineering toll-free at (888) 794-8351 Monday through Friday between 8 a.m. to 5 p.m. PT, e-mail sales@omniswivel.com, or visit the company's Web site at www.mj-engineering.com
Name of Product: AGA Swivels for Scuba Diving Masks
Units: About 1,500
Manufacturer: M&J Engineering, of Poway, Calif.
Hazard: The swivel, which is attached to a diving mask, could separate while diving. This will result in a sudden loss of the diver's air supply, causing the diver to engage in emergency ascent. This poses a risk of decompression sickness due to rapid ascent or drowning.
Incidents/Injuries: M&J Engineering has received one report of swivels separating from the masks while diving. No injuries have been reported.
Description: This recall involves all SW-3000 2nd stage 360-degree swivels for scuba diving masks manufactured between January 2004 and February 2005. The swivel has the date stamped on its body, below the patent number. Swivels that are already repaired have an arrow stamped on the top right corner of the swivel body.
Sold at: Diving retail stores nationwide between January 2004 and February 2005 for about $60.
Manufactured in: USA
Remedy: Consumers should immediately stop using the scuba diving masks with the swivel attached and contact M&J Engineering to receive a free repair.
Consumer Contact: For additional information, contact M&J Engineering toll-free at (888) 794-8351 Monday through Friday between 8 a.m. to 5 p.m. PT, e-mail sales@omniswivel.com, or visit the company's Web site at www.mj-engineering.com
Metz Fresh Announces Voluntary Recall of Spinach
Metz Fresh, LLC is voluntarily recalling bagged spinach as a result of a positive test for Salmonella found during routine company testing.
The spinach is distributed under the label Metz Fresh, in both retail and food service packages. These include 10 and 16 oz bags as well as 4-2.5 lb. and 4 lb. cartons. The only Metz Fresh product affected is spinach that bears the tracking codes 12208114, 12208214 and 12208314. It was distributed in the continental United States and Canada.
There have been no reports of illness or problems related to this spinach.
Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. While most individuals recover in three to five days without medical intervention, the infection can be life-threatening to young children, the elderly and those with compromised immune systems. Consumers with any of these symptoms should call their physician.
Consumers are advised to discard this product or return it to the place of purchase for a refund. Consumers with questions about the recall should contact 831-386-1018.
"Nothing is more important to Metz Fresh than the safety of our consumers, period," said Andrew Cumming, President of Metz Fresh. "As soon as we learned of the presumptive positive test, we directed all customers to hold all boxes of the spinach affected as a precaution. Now, with this positive test confirmation, there is no question that we would recall and destroy all spinach bearing these three codes."
The positive test came during independent lab testing Metz Fresh conducts on all of its products. Through its labeling and numbering system, Metz Fresh has already tracked, located and put 'holds' on the vast majority of the cartons of spinach affected. That spinach will not be released into the marketplace.
While the positive test came from only one sample of many on three packing lines, Metz Fresh has, as a precaution, chosen to recall all of the spinach from the ‘field lot’ packed that day on all three lines.
Metz Fresh is keeping appropriate authorities updated on the status of the voluntary recall.
The spinach is distributed under the label Metz Fresh, in both retail and food service packages. These include 10 and 16 oz bags as well as 4-2.5 lb. and 4 lb. cartons. The only Metz Fresh product affected is spinach that bears the tracking codes 12208114, 12208214 and 12208314. It was distributed in the continental United States and Canada.
There have been no reports of illness or problems related to this spinach.
Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. While most individuals recover in three to five days without medical intervention, the infection can be life-threatening to young children, the elderly and those with compromised immune systems. Consumers with any of these symptoms should call their physician.
Consumers are advised to discard this product or return it to the place of purchase for a refund. Consumers with questions about the recall should contact 831-386-1018.
"Nothing is more important to Metz Fresh than the safety of our consumers, period," said Andrew Cumming, President of Metz Fresh. "As soon as we learned of the presumptive positive test, we directed all customers to hold all boxes of the spinach affected as a precaution. Now, with this positive test confirmation, there is no question that we would recall and destroy all spinach bearing these three codes."
The positive test came during independent lab testing Metz Fresh conducts on all of its products. Through its labeling and numbering system, Metz Fresh has already tracked, located and put 'holds' on the vast majority of the cartons of spinach affected. That spinach will not be released into the marketplace.
While the positive test came from only one sample of many on three packing lines, Metz Fresh has, as a precaution, chosen to recall all of the spinach from the ‘field lot’ packed that day on all three lines.
Metz Fresh is keeping appropriate authorities updated on the status of the voluntary recall.
Wednesday, August 22, 2007
Select Red Flannel Large Breed Adult Formula Dry Dog Food 50lb Bags Voluntarily Recalled in Pennsylvania
August 21, 2007 -- Mars Petcare US, Inc. today announces a voluntary recall of select 50 lb bags of Red Flannel Large Breed Adult Formula dry dog food sold in two stores in Pennsylvania. Only three bags of product were actually sold, with only one bag still unaccounted for. 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: Red Flannel Large Breed Adult Formula dry dog food
Size: 50 pound bagUPC Code: 4286900062
Best Buy Date: July 12, 2008
Best Buy Date Location: Back of bag
Affected Stores: The stores are located in Reedsland, PA and Richlandville, PA
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 FDA detected Salmonella in a sample of Red Flannel Large Breed Adult Formula dry dog food with a best buy date of July 12, 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: Red Flannel Large Breed Adult Formula dry dog food
Size: 50 pound bagUPC Code: 4286900062
Best Buy Date: July 12, 2008
Best Buy Date Location: Back of bag
Affected Stores: The stores are located in Reedsland, PA and Richlandville, PA
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 FDA detected Salmonella in a sample of Red Flannel Large Breed Adult Formula dry dog food with a best buy date of July 12, 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.
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents
The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.
Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.
“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.
The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.
Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.
For more information:
FDA Office of Pediatric Therapeutics www.fda.gov/oc/opt/default.htm
National Institute of Mental Health—Schizophrenia www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm
National Institute of Mental Health—Bipolar Disorder www.nimh.nih.gov/healthinformation/bipolarmenu.cfm
Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.
“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.
The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.
Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.
For more information:
FDA Office of Pediatric Therapeutics www.fda.gov/oc/opt/default.htm
National Institute of Mental Health—Schizophrenia www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm
National Institute of Mental Health—Bipolar Disorder www.nimh.nih.gov/healthinformation/bipolarmenu.cfm
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