June 5, 2009Recalls and Safety Alerts: Raptiva Withdrawn from the Market Recalls and Safety Alerts: Raptiva Withdrawn from the Market
Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov June 4, 2009Recalls and Safety Alerts: Recall of Zencore Plus Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq... Source: www.accessdata.fda.gov New from FDA: Campaign on Using Methadone Safely New from FDA: Campaign on Using Methadone Safely
FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov FDA's MedWatch Safety Alerts: April 2009 FDA's MedWatch Safety Alerts: April 2009
Home Page for the Food and Drug Administration (FDA): Consumer Health Information Source: www.fda.gov June 3, 2009Sprout Recall Due to Potential Contamination with Listeria Sprout Recall Due to Potential Contamination with Listeria
On April 9, 2009, Amalgamated Produce, Inc. (API), Bridgeport, CT., announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov FDA Warns About Raw Alfalfa Sprouts FDA Warns About Raw Alfalfa Sprouts
On April 26, 2009, FDA and CDC recommended that consumers not eat raw alfalfa sprouts until further notice because the product has been linked to Salmonella contamination Source: www.fda.gov Algunos "extractos de vainilla" producidos en México no son una buena oferta Los turistas que se tientan a comprar ofertas al sur de la frontera deben tener cuidado de una oferta que no es una buena compra. Se trata de un llamado saborizante o extracto “de vainilla” que no lo es en absoluto, sino que está elaborado de una materia vegetal completamente diferente que contiene cumarina. Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines New Labeling Required for OTC Pain and Fever Medicines
On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov Some "Vanilla Extract" Produced in Mexico is No Bargain Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Source: www.fda.gov June 2, 2009FDA's MedWatch Safety Alerts: April 2009 FDA's MedWatch Safety Alerts: April 2009
Home Page for the Food and Drug Administration (FDA): Consumer Health Information Source: www.fda.gov More Weight Loss Products Added to Consumer Alert FDA has alerted consumers not to buy or use more than 25 weight-loss products Source: www.fda.gov Treating Cushing's Disease in Dogs Medications, including a recently approved drug, can help manage this disease that most commonly occurs in middle-aged and older dogs. Source: www.fda.gov H1N1 Flu: FDA Responds Quickly to Protect the Public's Health FDA is addressing the H1N1 flu outbreak with a team-based incident management approach Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov Insulin Pens are Not for Sharing Insulin pens should not be used on multiple patients. Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories Mobile laboratories help FDA quickly test food and drugs for contaminants. Source: www.fda.gov Algunos "extractos de vainilla" producidos en México no son una buena oferta Los turistas que se tientan a comprar ofertas al sur de la frontera deben tener cuidado de una oferta que no es una buena compra. Se trata de un llamado saborizante o extracto “de vainilla” que no lo es en absoluto, sino que está elaborado de una materia vegetal completamente diferente que contiene cumarina. Source: www.fda.gov FDA's MedWatch Safety Alerts: March 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards FDA 101: Clinical Trials and Institutional Review Boards
Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Source: www.fda.gov Pistachio Recall Expanded On April 6, 2009, Setton Pistachio of Terra Bella Inc., Terra Bella, Calif., voluntarily expanded its recall. Source: www.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov FDA's MedWatch Safety Alerts: March 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov More Weight Loss Products Added to Consumer Alert FDA has alerted consumers not to buy or use more than 25 weight-loss products Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov Insulin Pens are Not for Sharing Insulin pens should not be used on multiple patients. Source: www.fda.gov The Scoop on Whole Grains The Scoop on Whole Grains
What are whole grains and how much should you eat? Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories Mobile laboratories help FDA quickly test food and drugs for contaminants. Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov Sprout Recall Due to Potential Contamination with Listeria On April 9, 2009, Amalgamated Produce, Inc. (API), Bridgeport, CT., announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. Source: www.fda.gov June 1, 2009Recalls and Safety Alerts: Warning on Metoclopramide Recalls and Safety Alerts: Warning on Metoclopramide
FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl... Source: www.accessdata.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov Preventing Medical Errors: Removing Insulin from Cartons The Institute for Safe Medication Practices (ISMP) warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong ca... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes
Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl... Source: www.accessdata.fda.gov Preventing Medical Errors: Don?t Share Insulin Pens Between Patients FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as h... Source: www.accessdata.fda.gov Preventing Medical Errors: Removing Insulin from Cartons The Institute for Safe Medication Practices (ISMP) warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong ca... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Warning on Metoclopramide FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps
Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ... Source: www.accessdata.fda.gov May 31, 2009Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps
Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Warning on Metoclopramide FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl... Source: www.accessdata.fda.gov Preventing Medical Errors: Don?t Share Insulin Pens Between Patients FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as h... Source: www.accessdata.fda.gov Preventing Medical Errors: Removing Insulin from Cartons The Institute for Safe Medication Practices (ISMP) warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong ca... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams
FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been... Source: www.accessdata.fda.gov Preventing Medical Errors: Don?t Share Insulin Pens Between Patients FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as h... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Warning on Metoclopramide FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i... Source: www.accessdata.fda.gov |
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