[Posted 04/30/2010] McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. Some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com
[04/30/2010 - Questions and Answers1 - FDA]
Friday, April 30, 2010
Cardiac Science Automated External Defibrillators : Class I Recall Adds - Powerheart, Cardiovive, NK, Responder models
[UPDATED 04/27/2010] This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects.
Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
[Posted 03/08/2010] Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a Class 1 recall of automated external defibrillators (AED). These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death. List of affected models includes:
[04/27/2010 - Update on Defective Cardiac Science Corporation External Defibrillators1 - FDA]
[03/08/2010 - Recall Notice2 - FDA]
Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
[Posted 03/08/2010] Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a Class 1 recall of automated external defibrillators (AED). These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death. List of affected models includes:
- Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
- CardioVive 92531, 92532, 92533
- NK 9200G, 9231
- Responder 2019198 and 2023440.
[04/27/2010 - Update on Defective Cardiac Science Corporation External Defibrillators1 - FDA]
[03/08/2010 - Recall Notice2 - FDA]
Serious Liver Disorder with Videx (didanosine) or Videx EC.
FDA is notifying healthcare professionals about cases of a rare but serious complication, non-cirrhotic portal hypertension, in patients taking Videx (didanosine) or Videx EC, to treat HIV infection.
Clinicians should monitor patients on Videx for portal hypertension and esophageal varices. They should also be aware that Videx has been associated with other hepatic effects, including lactic acidosis, hepatomegaly with steatosis, and liver failure.
FDA believes that for certain patients, the clinical benefits of Videx continue to outweigh its risks, and that the decision to use the drug must be made on an individual basis.
Additional Information:
Clinicians should monitor patients on Videx for portal hypertension and esophageal varices. They should also be aware that Videx has been associated with other hepatic effects, including lactic acidosis, hepatomegaly with steatosis, and liver failure.
FDA believes that for certain patients, the clinical benefits of Videx continue to outweigh its risks, and that the decision to use the drug must be made on an individual basis.
Additional Information:
Meridia (sibutramine) increases their risk of heart attack and stroke in patients with a history of cardiovascular disease
FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity.
In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Meridia had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.
Based on this information, Meridia is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Meridia and discontinue the drug if there are sustained increases in these measurements.
They should also discontinue Meridia in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Meridia should talk with their healthcare professional about whether to continue using the drug.
Additional Information:
In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Meridia had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.
Based on this information, Meridia is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Meridia and discontinue the drug if there are sustained increases in these measurements.
They should also discontinue Meridia in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Meridia should talk with their healthcare professional about whether to continue using the drug.
Additional Information:
Association of INVIRASE® (saquinavir mesylate) with significant dose-dependent prolongations of QT and PR intervals in healthy volunteers
Invirase (saquinavir mesylate)
Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform healthcare professionals of important new safety information regarding the use of INVIRASE® (saquinavir mesylate) and significant dose-dependent prolongations of QT and PR intervals in healthy volunteers.
INVIRASE is authorized for the treatment of HIV-1 infected adult patients. INVIRASE should only be given in combination with ritonavir and other antiretroviral medicinal products.
Saquinavir ATC Code: J05AE01 INVIRASE is authorized for the treatment of HIV-1 infected adult patients. INVIRASE should only be given in combination with ritonavir and other antiretroviral medicinal products.
Warning
Hoffmann-La Roche Limited would like to bring attention to the fact that dose-dependent prolongations of QT and PR intervals have been observed in healthy volunteers taking ritonavir-boosted Invirase.Evidence
FairReference
FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication.
Propylthiouracil
Audience: Endocrine healthcare professionals, Pharmacists, Pediatricians[Updated 04/21/2010] FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication.
[Posted 06/04/2009] FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with proplythiouracil when compared to methimazole. FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil use. Although both proplythiouracil and methimazole are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on propylthiouracil therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available.
[04/21/2010 - Drug Safety Communication1 - FDA]
[06/04/2009 - Healthcare Professional Sheet2 - FDA]
Promethazine is not to be used in children under the age of two years due to the potentially fatal risk of respiratory depression (slowed breathing).
Promethazine is not to be used in children under the age of two years due to the potentially fatal risk of respiratory depression (slowed breathing). Caution should be used when administering promethazine in children aged two and up: health care professionals are recommended to use the lowest effective dose, and the use of other drugs that may also slow breathing should be avoided. Promethazine is not to be injected under the skin (subcutaneously) due to the risk of serious tissue injury. The preferred route of administration for promethazine is by injection directly and deeply into a muscle (deep intramuscular injection). Other routes of injection, particularly into arteries or veins, have been associated with serious tissue injury. Regardless of where on the body the drug is injected, promethazine has the potential to occasionally cause chemical irritation and in rare cases severe tissue damage at the site of injection, including cases of gangrene. Patients should immediately report any persistent or worsening pain or burning sensation they feel at the site of injection.
Promethazine
Posted 2 days ago by David ChanPromethazine
ATC Code: R06AD02News Source
Health Canada MedEffectNews Date
April 26, 2010Brief Description
Promethazine is not to be used in children under the age of two years due to the potentially fatal risk of respiratory depression (slowed breathing).
Caution should be used when administering promethazine in children aged two and up: health care professionals are recommended to use the lowest effective dose, and the use of other drugs that may also slow breathing should be avoided.
Promethazine is not to be injected under the skin (subcutaneously) due to the risk of serious tissue injury.
The preferred route of administration for promethazine is by injection directly and deeply into a muscle (deep intramuscular injection). Other routes of injection, particularly into arteries or veins, have been associated with serious tissue injury.
Regardless of where on the body the drug is injected, promethazine has the potential to occasionally cause chemical irritation and in rare cases severe tissue damage at the site of injection, including cases of gangrene. Patients should immediately report any persistent or worsening pain or burning sensation they feel at the site of injection.Reference
FDA Takes Steps to Increase Safety of Foods During Transport
Agency poised to set new safety standards for the transportation of food in commerce; provides new guidance
The U.S. Food and Drug Administration is asking commercial food transporters to follow new guidance the agency is issuing today to reduce the chances of physical, chemical, biological and other risks during transportation of foods while the agency reviews current food safety transportation regulations.
In an advance notice of proposed rulemaking (ANPRM) published in today's Federal Register, the FDA has requested input on writing the new rules from all interested parties, including the food and transportation industries and consumer interest organizations. The ANPRM is the first step in creating new regulations to govern sanitary practices by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in the transportation of food products for people and animals.
The new industry guidance covers safety measures that should be employed while the regulations are being written and finalized. They include ensuring that food in transit is maintained at appropriate temperatures; that such food is closely monitored for pests; that the vehicles used to transport foods are sanitary and in proper working condition; that pallets used are of good quality; and that sanitary measures are followed in the loading and unloading of foods.
"Our aim is to look at every component of the system to assess hazards, and to take science-based action where appropriate to maximize the safety of our food from farms all the way to consumers' tables," said FDA’s associate commissioner for food protection, Jeff Farrar. “Although contamination of food product during commercial transport is relatively infrequent, the potential harm can be widespread and serious.”
After evaluating comments received in response to the ANPRM, the FDA will propose specific regulations. The FDA will coordinate with the U.S. departments of Agriculture and Transportation in the rulemaking process.
For more information:
The U.S. Food and Drug Administration is asking commercial food transporters to follow new guidance the agency is issuing today to reduce the chances of physical, chemical, biological and other risks during transportation of foods while the agency reviews current food safety transportation regulations.
In an advance notice of proposed rulemaking (ANPRM) published in today's Federal Register, the FDA has requested input on writing the new rules from all interested parties, including the food and transportation industries and consumer interest organizations. The ANPRM is the first step in creating new regulations to govern sanitary practices by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in the transportation of food products for people and animals.
The new industry guidance covers safety measures that should be employed while the regulations are being written and finalized. They include ensuring that food in transit is maintained at appropriate temperatures; that such food is closely monitored for pests; that the vehicles used to transport foods are sanitary and in proper working condition; that pallets used are of good quality; and that sanitary measures are followed in the loading and unloading of foods.
"Our aim is to look at every component of the system to assess hazards, and to take science-based action where appropriate to maximize the safety of our food from farms all the way to consumers' tables," said FDA’s associate commissioner for food protection, Jeff Farrar. “Although contamination of food product during commercial transport is relatively infrequent, the potential harm can be widespread and serious.”
After evaluating comments received in response to the ANPRM, the FDA will propose specific regulations. The FDA will coordinate with the U.S. departments of Agriculture and Transportation in the rulemaking process.
For more information:
Monday, April 26, 2010
Covidien Recalls Shiley™ Tracheostomy Tubes Due To Air Leaks.
Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.
Recallr: Covidien Recalls Shiley™ Tracheostomy Tubes
Recallr: Covidien Recalls Shiley™ Tracheostomy Tubes
Tuesday, April 20, 2010
FDA's Stance On IOM Sodium Report & Washington Post Story
FDA's Stance On IOM Sodium Report
FDA has issued an statement to clarify it's stance on the amount of sodium in foods and the regulation of it. A leading news paper Washington Post gives amistaken impression that the FDA has begun the process of regulating the amount of sodium in foods.
The FDA is not currently working on regulations nor have they made a decision to regulate sodium content in foods at this time.
Following is the statement issued by FDA in it's entirety.
For Immediate Release: April 20, 2010
Media Inquiries: Meghan Scott, 301-796-4675, Meghan.Scott@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Statement on IOM Sodium Report
FDA has issued an statement to clarify it's stance on the amount of sodium in foods and the regulation of it. A leading news paper Washington Post gives amistaken impression that the FDA has begun the process of regulating the amount of sodium in foods.
The FDA is not currently working on regulations nor have they made a decision to regulate sodium content in foods at this time.
Following is the statement issued by FDA in it's entirety.
For Immediate Release: April 20, 2010
Media Inquiries: Meghan Scott, 301-796-4675, Meghan.Scott@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Statement on IOM Sodium Report
Today’s average sodium intake is several times what the body requires and its long-term effect on our health is very serious. Hypertension, or high blood pressure, affects one in three U.S. adults – nearly 75 million people aged 20 or older. An additional 50 million adults suffer from pre-hypertension. High blood pressure can increase the risk for heart attacks, strokes, heart failure, and kidney failure. Too much sodium in the daily diet is a major contributor to high blood pressure.
A new report from the Institute of Medicine this week concludes that national action is imperative to reduce the sodium content of foods if we are to make significant progress toward reducing the risk of hypertension and major cardiovascular events for Americans.
A story in today’s Washington Post leaves a mistaken impression that the FDA has begun the process of regulating the amount of sodium in foods. The FDA is not currently working on regulations nor have they made a decision to regulate sodium content in foods at this time.
Over the coming weeks, the FDA will more thoroughly review the recommendations of the IOM report and build plans for how the FDA can continue to work with other federal agencies, public health and consumer groups, and the food industry to support the reduction of sodium levels in the food supply. The Department of Health and Human Services will be establishing an interagency working group on sodium at the Department that will review options and next steps
Success in reducing sodium intake will require coordinated national action, with participation of all. We are encouraged by the fact that some food manufacturers have already begun or announced their commitment to reduce sodium levels in their products.
As a consumer, you can start lowering your sodium intake today by purchasing foods low in sodium, asking your grocer to carry more low-sodium products, and asking for low-sodium options at restaurants.
Collaborating to Reduce Preventable Harm from Medications, FDA's Safe Use Initiative
Medicine safety
Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.
The approaches used today for managing medication risks in the United States were put in place over the last century, often in a piecemeal fashion and usually in response to various crises and specific needs. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use. All participants in the healthcare community at large—patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, FDA, and other Federal agencies—have a role to play in managing medication risks and reducing preventable harm from medication. We believe that much preventable harm from medications results from problems that can be addressed best in a more coordinated, systematic manner, with interventions across all sectors of the medication distribution and use system.Medicine safety
FDA’s Safe Use Initiative contained in the report (Click on the link at the end for a PDF version on the report). Through this initiative, FDA seeks to partner and collaborate with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm. Cases will be carefully analyzed for their potential for coordinated FDA/stakeholder actions to better manage related risks and reduce harm. If the analysis suggests a potential benefit from an intervention, FDA and its interested partners will develop appropriate activities and evaluation metrics. In the months ahead, FDA intends to:
FDA's (Food and Drug Administration) Safe Use Initiative
Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.
The approaches used today for managing medication risks in the United States were put in place over the last century, often in a piecemeal fashion and usually in response to various crises and specific needs. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use. All participants in the healthcare community at large—patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, FDA, and other Federal agencies—have a role to play in managing medication risks and reducing preventable harm from medication. We believe that much preventable harm from medications results from problems that can be addressed best in a more coordinated, systematic manner, with interventions across all sectors of the medication distribution and use system.Medicine safety
FDA’s Safe Use Initiative contained in the report (Click on the link at the end for a PDF version on the report). Through this initiative, FDA seeks to partner and collaborate with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm. Cases will be carefully analyzed for their potential for coordinated FDA/stakeholder actions to better manage related risks and reduce harm. If the analysis suggests a potential benefit from an intervention, FDA and its interested partners will develop appropriate activities and evaluation metrics. In the months ahead, FDA intends to:
• Develop a general list of candidate cases for collaborative analysis and intervention. The list will be developed through extensive consultation with all interested public and private stakeholders and may include one or more of the existing opportunities listed in the Proposal section of this report.Through a coordinated effort, involving all interested stakeholders, we can work to minimize the risks associated with using medications and reduce preventable harm.
• Collaborate with Federal partners to develop population‐based national estimates of preventable harm from medications, categorized by drug, drug classes, and therapeutic situations.
• Open a public docket to receive suggestions and comments related to this report, risk management issues, and proposed candidate cases.
• Hold a series of meetings to gather broad public feedback as the candidate list is being developed.
• Based on the public contribution just outlined and the best available population‐based data, work with interested partners to select specific candidate cases for analysis, intervention proposals, and evaluation metrics.
• During the Initiative’s first 12 months, implement a small number of interventions. Each intervention will have an explicit plan for measuring impact. Interventions may involve FDA regulatory actions in concert with actions by other stakeholders.
FDA's (Food and Drug Administration) Safe Use Initiative
Monday, April 19, 2010
Adolescents may experience weight gain and hyperlipidemia with Zyprexa.
Physicians, patients and caregivers should understand that adolescents may experience weight gain and hyperlipidemia with Zyprexa. In fact, they have a greater risk of these effects than adults. They are likely to gain more weight than adults and have greater increases in total cholesterol, LDL cholesterol, triglycerides, prolactin, and hepatic transaminase levels. Adolescents are also more likely to experience sedation than adults. Clinicians should take these effects into account when deciding on antipsychotic medications for adolescents, and they may want to consider trying other drugs first.
If Zyprexa is prescribed for adolescents, it should be part of a comprehensive treatment program that often includes psychological, educational and social components. It is also important to note that Zyprexa has not been approved for patients under the age of 13.
MPEG Movie
Windows Media Movie
Additional Information:
FDA MedWatch Safety Alert. Zyprexa (olanzapine): Use in Adolescents. January 29, 2010
Thursday, April 15, 2010
Health Insurance Companies Shifting Costs To Avoid New MLR Laws!
Reuters is reporting that Health insurance companies are at it to beat the law. These laws include provisions such as large group plans are required to spend at least 85 cents the dollar collected on actual medical care as opposed to administrative costs. The small group plans and individual plans have to spend 80 cents on the dollar. So some of the largest U.S. health insurers are changing their accounting practices to book administration costs as medical costs in an attempt to circumvent new industry reforms, according to a U.S. Senate panel's report released on Thursday.
One insurer WellPoint Inc "has already 'reclassified' more than half a billion dollars of administrative expenses as medical expenses," according to the report. The MLR rule does not come in to effect until January 1, 2011, but according to Senator John Rockefeller, the committee's chairman insurers are "still far below" what the law will requires.
reuters
One insurer WellPoint Inc "has already 'reclassified' more than half a billion dollars of administrative expenses as medical expenses," according to the report. The MLR rule does not come in to effect until January 1, 2011, but according to Senator John Rockefeller, the committee's chairman insurers are "still far below" what the law will requires.
reuters
Insurance Companies Selling Fast Food!
Insurance companies, 11 of them, that deal with yours and my life, disability, or health insurance are holding about $1.9 billion in stock in the five largest fast-food companies as of June 2009, according to Harvard Medical School researchers.
The fast-food companies involved are McDonald's, Burger King, and Yum! Brands (the parent company of KFC and Taco Bell).
U.S.-based Massachusetts Mutual, Northwestern Mutual, and Prudential Financial were among the insurers listed.
"The insurance industry cares about making money, and it doesn't really care how," says the senior author of the study, J. Wesley Boyd, M.D., an assistant clinical professor of psychiatry at Harvard Medical School, in Boston. "They will invest in products that contribute to significant morbidity and mortality if doing so is going to make money."
American Journal Of Public Health via CNN
The fast-food companies involved are McDonald's, Burger King, and Yum! Brands (the parent company of KFC and Taco Bell).
U.S.-based Massachusetts Mutual, Northwestern Mutual, and Prudential Financial were among the insurers listed.
"The insurance industry cares about making money, and it doesn't really care how," says the senior author of the study, J. Wesley Boyd, M.D., an assistant clinical professor of psychiatry at Harvard Medical School, in Boston. "They will invest in products that contribute to significant morbidity and mortality if doing so is going to make money."
American Journal Of Public Health via CNN