FDA Sunday Recall Jan 23
- File Under FDA
Pretzels. Inc. Issues Allergy Alert On Undeclared Milk In Better Made Brand Corn Pops
Contact: Pretzels, Inc. 1- 800-456-4838
FOR IMMEDIATE RELEASE - January 21, 2011 - Pretzels, Inc. of Bluffton, Indiana is recalling its 8 ounce packages of Better Made brand Corn Pops because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Corn Pops were distributed to retail stores in Michigan and Ohio. The product is packaged under the Better Made brand Corn Pops label with an expiration code of MAR1411. The UPC code on the package is 041633-003716. No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown of the company’s production and packaging processes. Consumers who have purchased 8 ounce packages of Better Made Corn Pops are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Pretzels, Inc. at 1- 800-456-4838 between the hours of 8:00 a.m. and 5:00 p.m., Monday through Friday.
Contact: Pretzels, Inc. 1- 800-456-4838
FOR IMMEDIATE RELEASE - January 21, 2011 - Pretzels, Inc. of Bluffton, Indiana is recalling its 8 ounce packages of Better Made brand Corn Pops because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Corn Pops were distributed to retail stores in Michigan and Ohio. The product is packaged under the Better Made brand Corn Pops label with an expiration code of MAR1411. The UPC code on the package is 041633-003716. No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown of the company’s production and packaging processes. Consumers who have purchased 8 ounce packages of Better Made Corn Pops are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Pretzels, Inc. at 1- 800-456-4838 between the hours of 8:00 a.m. and 5:00 p.m., Monday through Friday.
Hawaii Business Group Incorporated, Barb’s Favorite Recipes, and Ohana Seafoods Recall Barb’s Local Style Black Bean Sauce and Ohana Flavors Black Bean Sauce Because of Possible Health Risk
Contact:Hawaii Business Group, Incorporated808-676-0880
FOR IMMEDIATE RELEASE - January 19, 2011 - Hawaii Business Group Incorporated, Barb’s Favorite Recipes, and Ohana Seafoods are recalling Barb’s Local Style Black Bean Sauce and Ohana Flavors Black Bean Sauce because of possible health risks due to the potential growth of Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The sauce was manufactured by First Commercial Kitchen LLC.
Botulism, a potentially fatal form of food poisoning, may cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
The Black Bean Sauce is sold in 12oz. glass jars and labeled as Barb’s Local Style Black Bean Sauce or Ohana Flavors Black Bean Sauce. The UPC numbers on the product are 6-75981-42491-8 and 7-02003-72739-6. The recalled sauce was distributed on Oahu and Molokai.
No illnesses have been reported to date in connection with this problem. A routine inspection discovered the problem.
Consumers may contact Hawaii Business Group, Incorporated at 808-676-0880 between 7:30AM and 3PM, Monday through Friday for further information.
Contact:Hawaii Business Group, Incorporated808-676-0880
FOR IMMEDIATE RELEASE - January 19, 2011 - Hawaii Business Group Incorporated, Barb’s Favorite Recipes, and Ohana Seafoods are recalling Barb’s Local Style Black Bean Sauce and Ohana Flavors Black Bean Sauce because of possible health risks due to the potential growth of Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The sauce was manufactured by First Commercial Kitchen LLC.
Botulism, a potentially fatal form of food poisoning, may cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
The Black Bean Sauce is sold in 12oz. glass jars and labeled as Barb’s Local Style Black Bean Sauce or Ohana Flavors Black Bean Sauce. The UPC numbers on the product are 6-75981-42491-8 and 7-02003-72739-6. The recalled sauce was distributed on Oahu and Molokai.
No illnesses have been reported to date in connection with this problem. A routine inspection discovered the problem.
Consumers may contact Hawaii Business Group, Incorporated at 808-676-0880 between 7:30AM and 3PM, Monday through Friday for further information.
Federal Government obtains permanent injunction against Deltex Pharmaceuticals Inc.Company charged with manufacturing and distributing drugs in violation of federal law
The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.
The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.
Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. The government’s complaint, filed by the U.S. Department of Justice, detailed violations of the Federal Food, Drug, and Cosmetic Act involving manufacturing and distributing unapproved, adulterated, and misbranded drugs. Specifically, Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements.
The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.
The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.
Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. The government’s complaint, filed by the U.S. Department of Justice, detailed violations of the Federal Food, Drug, and Cosmetic Act involving manufacturing and distributing unapproved, adulterated, and misbranded drugs. Specifically, Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements.
Mama Rose's Gourmet Foods Recalls Cilantro Con Queso, Garlic Con Queso, Viper Venom Con Queso and Hopi Corn Salsa Because of Possible Health Risk
Contact:Mama Rose's Gourment Foods
Contact:Mama Rose's Gourment Foods
P.O. Box 36852 Phoenix, AZ 86067602-477-8286
FOR IMMEDIATE RELEASE - January 20, 2011 - Mama Rose's Gourmet Foods of Phoenix, AZ is voluntarily recalling Cilantro Con Queso, Garlic Con Queso, Viper Venom Con Queso and Hopi Corn Salsa, because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
FOR IMMEDIATE RELEASE - January 20, 2011 - Mama Rose's Gourmet Foods of Phoenix, AZ is voluntarily recalling Cilantro Con Queso, Garlic Con Queso, Viper Venom Con Queso and Hopi Corn Salsa, because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
FDA recalls 'Nuclear Sludge' candy bars
By Andrew Restuccia - 01/14/11 03:33 PM ET
If you hadn’t already thought twice about eating Toxic Waste Nuclear Sludge candy bars, the Food and Drug Administration (FDA) just gave you good reason to opt for a Twix or Snickers instead.
The FDA announced Friday that the company that sells the bars, Indianapolis-based Candy Dynamics, has issued a voluntary recall of the product.The recall comes after the California Department of Public Health found potentially unsafe levels of lead in the cherry-flavored Nuclear Sludge bars. The company is recalling all flavors of the bars, including sour apple and blue raspberry.The FDA stressed that there have been no reported cases of people getting sick from the bars, which are manufactured in Pakistan.
FDA Elevates Recall of Dialysis Set
By Cole Petrochko, Staff Writer, MedPage TodayPublished: January 22, 2011
WASHINGTON -- The FDA upgraded the recall of a dialysis tubing and priming set to class I -- the agency's most serious -- due to potentially fatal red blood cell damage that may occur with product use.
Manufacturer Fresenius Medical Care pulled several lots of the CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor after the company received reports of arterial kinking following use of the dialysis set, which may cause hemolysis.
The kinking may develop prior to or during use and may not be apparent until after the blood tubing warms, the company noted in a statement. The most commonly affected location is in the pre- or post-cuvette tubing segments entering or leaving the blood volume monitor module. The kinks are not always visible because they may occur in the tubing behind the blood volume monitor module door.
Fresenius noted that there have been reports of re-needling when operators mistakenly concluded that an access problem existed. "There is also the possibility for the inappropriate administration of tissue plasminogen activator (tPA) if operators mistakenly conclude there is an access problem," the statement said.
The recall affects several lots two specific parts, including:
Part number 03-2695-9, lots 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
Part number 03-2795-7, lots 09JR01174, 09JR01229, 09NR01139, 10KR01801
Fresenius Medical Care initiated the recall in November 2010 when it distributed an urgent recall notice to customers, including instructions to identify affected lots, discontinue use of those products, and to return the recalled items, an FDA statement said.
The devices were manufactured from June 11, 2010 to Oct. 17, 2010 and distributed until November 2010, the statement said.
The recall affects over 200,000 combined units of the pulled parts, according to the company.
Class I recalls affect products that have a reasonable probability of causing serious injury or death with use.
By Cole Petrochko, Staff Writer, MedPage TodayPublished: January 22, 2011
WASHINGTON -- The FDA upgraded the recall of a dialysis tubing and priming set to class I -- the agency's most serious -- due to potentially fatal red blood cell damage that may occur with product use.
Manufacturer Fresenius Medical Care pulled several lots of the CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor after the company received reports of arterial kinking following use of the dialysis set, which may cause hemolysis.
The kinking may develop prior to or during use and may not be apparent until after the blood tubing warms, the company noted in a statement. The most commonly affected location is in the pre- or post-cuvette tubing segments entering or leaving the blood volume monitor module. The kinks are not always visible because they may occur in the tubing behind the blood volume monitor module door.
Fresenius noted that there have been reports of re-needling when operators mistakenly concluded that an access problem existed. "There is also the possibility for the inappropriate administration of tissue plasminogen activator (tPA) if operators mistakenly conclude there is an access problem," the statement said.
The recall affects several lots two specific parts, including:
Part number 03-2695-9, lots 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
Part number 03-2795-7, lots 09JR01174, 09JR01229, 09NR01139, 10KR01801
Fresenius Medical Care initiated the recall in November 2010 when it distributed an urgent recall notice to customers, including instructions to identify affected lots, discontinue use of those products, and to return the recalled items, an FDA statement said.
The devices were manufactured from June 11, 2010 to Oct. 17, 2010 and distributed until November 2010, the statement said.
The recall affects over 200,000 combined units of the pulled parts, according to the company.
Class I recalls affect products that have a reasonable probability of causing serious injury or death with use.
January 17, 2011
Cautionary recall of swabs used for Fuzeon and Pegasys announced
Alcohol swabs co-packaged with the HIV drug Fuzeon and the HCV drug Pegasys, as well as other injected prescriptions, may be contaminated with Bacillus cereus. The recall includes alcohol prep pads, swabs and swabsticks made by the Triad Group.
Cautionary recall of swabs used for Fuzeon and Pegasys announced
Alcohol swabs co-packaged with the HIV drug Fuzeon and the HCV drug Pegasys, as well as other injected prescriptions, may be contaminated with Bacillus cereus. The recall includes alcohol prep pads, swabs and swabsticks made by the Triad Group.
Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group’s Alcohol Prep Products
Genentech Informs Customers Of Important Information About Triad Group's Alcohol Prep Pads
Contact:Media:Tara Iannuccillo(650) 467-6800Investor:Investor Relations North America(650) 225-4150
FOR IMMEDIATE RELEASE - January 13, 2011 -Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, http://www.fda.gov/Safety/Recalls/ucm239219.htm).
Contact:Media:Tara Iannuccillo(650) 467-6800Investor:Investor Relations North America(650) 225-4150
FOR IMMEDIATE RELEASE - January 13, 2011 -Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, http://www.fda.gov/Safety/Recalls/ucm239219.htm).
The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase to customers in the United States.According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.It is important to note, that Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration. Genentech is in discussion with the FDA and is currently assessing alternatives to address the situation. The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.Further information about the Triad Group recall can be found on the FDA website athttp://www.fda.gov/Safety/MedWatch/SafetyInformation
Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact the Patient Resource Center at 1-877-436-3683 between the hours of 6 am and 5 pm Pacific Time.For the Boniva indication, full prescribing information, and important safety information, please visit http://www.boniva.com/.For the Fuzeon indication, full prescribing information, and important safety information, please visit http://www.fuzeon.com/.For the Nutropin A.Q. Pen indication, full prescribing information, and important safety information, please visit http://www.nutropin.com/.For the Pegasys indication, full prescribing information, and important safety information including Boxed WARNING and Medication Guide, please visit http://www.pegasys.com.For the TNKase indication, full prescribing information, and important safety information, please visit http://www.tnkase.com/.
Contact:Rose Talarico, Bayer HealthCare, mailto:rose.talarico@bayer.com?subject=Email, (973) 305-5302Rosemarie Yancosek, Bayer HealthCare, mailto:rosemarie.yancosek@bayer.com?subject=Email, (973) 305-5213
In the interest of patient safety, Bayer wants to ensure that U.S. patients and physicians using Bayer’s Betaseron are aware of the Triad recall. The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria, Bacillus cereus, that could lead to life-threatening infections. Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients. There is NO involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States. Bayer instructs patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol. Bayer is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration. In the interim, Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad. Bayer has posted this important information on its websites. Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/
If you have additional questions, please consult with your pharmacist or healthcare provider or contact BETAPLUS at 1-800-788-1467 option 1 to speak to a BETA Nurse. Or call Bayer at 1-888-84-BAYER, where operators will be available 24 hours a day to respond to questions from consumers or medical professionals. Members of the media should call Rosemarie Yancosek at 973/305-5213 or Rose Talarico at 973/305-5302.Bayer will provide additional information when it becomes available. BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.IMPORTANT SAFETY INFORMATION
BETASERON should be used with caution in patients with depression.
Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
Female patients should be warned about the potential risk to pregnancy.
Cases of anaphylaxis have been reported rarely.
The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information available at http://www.betaseron.com/.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information please see the full Prescribing Information available at www.betaseron.com.
About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
BETASERON should be used with caution in patients with depression.
Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
Female patients should be warned about the potential risk to pregnancy.
Cases of anaphylaxis have been reported rarely.
The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information available at http://www.betaseron.com/.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information please see the full Prescribing Information available at www.betaseron.com.
About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
1-14-2011] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq).
Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Dronedarone can reduce the risk of being hospitalized for these heart problems. Since dronedarone's approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.1 Additional usage can occur in the hospital setting.
Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.
Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.
Today's communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. FDA is continuing to review reports of possible adverse events and drug interactions with dronaderone submitted to our Adverse Event Reporting System.
Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Dronedarone can reduce the risk of being hospitalized for these heart problems. Since dronedarone's approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.1 Additional usage can occur in the hospital setting.
Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.
Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.
Today's communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. FDA is continuing to review reports of possible adverse events and drug interactions with dronaderone submitted to our Adverse Event Reporting System.
[1-13-2011] The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.
In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.
Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).
OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.
In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.
Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).
OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.
Lantus (insulin glargine)
Audience - Diabetes healthcare professionals, patients
[UPDATED 01/12/2011] FDA has reviewed studies and determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent ability to attribute the observed cancer risk to Lantus.
At this time, FDA has not concluded that Lantus increases the risk of cancer. FDA's review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information.
Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Lantus.
Patients should continue taking Lantus unless told otherwise by their healthcare professional.
For more information on FDA's review, please refer to the January 12 2011
Audience - Diabetes healthcare professionals, patients
[UPDATED 01/12/2011] FDA has reviewed studies and determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent ability to attribute the observed cancer risk to Lantus.
At this time, FDA has not concluded that Lantus increases the risk of cancer. FDA's review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information.
Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Lantus.
Patients should continue taking Lantus unless told otherwise by their healthcare professional.
For more information on FDA's review, please refer to the January 12 2011
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