FDA NEWS

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