June 26, 2009Fun Express Water-based Face Paints for Children Fun Express Water-based Face Paints for Children
UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) Source: www.fda.gov Testosterone gel products (AndroGel 1% and Testim 1% ) Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. Source: www.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 Stamina-Rx Dietary Supplement Products Stamina-Rx Dietary Supplement Products
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. Hi-Tech was notified by the FDA that the lab analysis of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 inhibitor. Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein Source: www.fda.gov Cefepime (marketed as Maxipime) Update of Ongoing Safety Review FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Source: www.fda.gov U.S. Attorney News Release: Former Managing Pharmacist Pleads Guilty To Conspiracy to Defraud Health Insurers The former managing pharmacist at a Middlesex County pharmacy pleaded guilty today to conspiring to defraud health insurers, including the federal Medicaid program, by submitting phony claims for reimbursement for prescription drugs, Acting U.S. Attorney Ralph J. Marra, Jr., announced. Source: www.fda.gov FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish) La Administración de Medicamentos y Alimentos de los Estados Unidos se ha enterado que algunas ampollas de insulina Levemir de acción prolongada, medicamento elaborado por Novo Nordisk Inc., que habían sido robadas, han aparecido y se encuentran a la venta en los Estados Unidos. El total de ampollas robadas es de 129,000 unidades, lo que equivale a tres lotes del producto. Cabe la posibilidad de que estas ampollas de insulina robadas no hayan sido almacenadas ni manipuladas adecuadamente, lo que puede ser peligroso para los pacientes que la usan. Source: www.fda.gov Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review FDA provides its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Source: www.fda.gov June 25, 2009FDA Consumer Corner: Don?t Overdo It with Acetaminophen FDA Consumer Corner: Don?t Overdo It with Acetaminophen
If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish) La Administración de Medicamentos y Alimentos de los Estados Unidos se ha enterado que algunas ampollas de insulina Levemir de acción prolongada, medicamento elaborado por Novo Nordisk Inc., que habían sido robadas, han aparecido y se encuentran a la venta en los Estados Unidos. El total de ampollas robadas es de 129,000 unidades, lo que equivale a tres lotes del producto. Cabe la posibilidad de que estas ampollas de insulina robadas no hayan sido almacenadas ni manipuladas adecuadamente, lo que puede ser peligroso para los pacientes que la usan. Source: www.fda.gov FDA Issues Public Health Advisory Regarding Levemir Insulin The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. Source: www.fda.gov U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007. Source: www.fda.gov FDA Requests Labeling Change for Leukotriene Modifiers The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). Source: www.fda.gov U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials U.S. Attorney news release Source: www.fda.gov FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Source: www.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 FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under. Source: www.fda.gov June 24, 2009Cefepime (marketed as Maxipime) Update of Ongoing Safety Review Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Source: www.fda.gov Propylthiouracil Propylthiouracil (PTU)-Induced Liver Failure Source: www.fda.gov Nestle Toll House Prepackaged, Refrigerated Cookie Dough FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death. Source: www.fda.gov June 23, 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 FDA Consumer Corner: Don?t Overdo It with Acetaminophen If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... 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: 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 Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov Testosterone gel products (AndroGel 1% and Testim 1% ) Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. Source: www.fda.gov Nestle Toll House Prepackaged, Refrigerated Cookie Dough FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death. Source: www.fda.gov June 22, 2009Warnings on Three Zicam Intranasal Zinc Products Warnings on Three Zicam Intranasal Zinc Products
FDA has warned consumers not to use three Zicam intranasal products because the products may cause a loss of sense of smell. Source: www.fda.gov La FDA promueve la apertura y la transparencia hacia el público La FDA está trabajando para que el público tenga un mejor acceso a toda información de utilidad sobre sus actividades y su toma de decisiones. Source: www.fda.gov FDA Warns Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough FDA warns consumers not to eat Nestle Toll House prepackaged, refrigerated cookie dough Source: www.fda.gov FDA's MedWatch Safety Alerts: June 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov Giving Medication to Children The director of FDA's Office of Pediatric Therapeutics discusses what parents should know about medication. use in children. 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 Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled 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 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 Influend Cough and Cold Products Influend Cough and Cold Products Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov June 21, 2009Patients Alerted to Pacemaker Recall Patients Alerted to Pacemaker Recall
FDA has alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers Source: www.fda.gov FDA Requests Labeling Change for Leukotriene Modifiers FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). Source: www.fda.gov FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus. Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Sirolimus (marketed as Rapamune) FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Source: www.fda.gov Nestle Toll House Prepackaged, Refrigerated Cookie Dough FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death. Source: www.fda.gov Levemir Insulin (Novo Nordisk) Patients advised to check personal supply of insulin to identify possible stolen and dangerous product. Source: www.fda.gov Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) Source: www.fda.gov Recalls 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 FDA's MedWatch Safety Alerts: June 2009 FDA has issued recent safety alerts on these medical products. Source: www.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 |
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