News Tagged ‘FDA

Tamiflu dispensers cause dosage confusion and errors

tamiflu 100x100The U.S. Food and Drug Administration issued a public health alert Thursday after finding errors with the measurements on the dosing dispenser included in Tamiflu packaging. Tamiflu is the brand name of Oseltamivir, an antiviral prescription drug used to treat people infected with the influenza virus. Produced by Swiss global health care company F. Hoffman-La Roche Ltd., Tamiflu has been used extensively throughout the world during the last decade to help curb the spread of the flu virus within patients.

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Steering clear of potentially contaminated food

leafy greensThe U.S. Food and Drug Administration announced another massive recall of fresh produce last week, this time for 1,715 cartons of bunched spinach that tested positive for salmonella bacteria in a random test conducted by the USDA. Alarmed by the frequency of foods recalled over bacterial contamination fears, many consumer advocacy groups and legislators have indicted the federal government’s food inspection system, calling for an overhaul of the FDA and USDA systems currently in place. But in an age of mass production and processing that makes cross contamination ever more likely, it’s wise for the consumer to take certain measures to mitigate the risk of becoming sick from tainted food.

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Surgical drills, blades, shavers self-activate spurring Class 1 recall

PowerProElectricOscil1 100x100The Food and Drug Administration (FDA) has issued a Class 1 recall on a type of surgical drills, blades and bone and cutting devices because the tools can unintentionally self-activate and move in unintended directions. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that the use of the products will cause serious or .

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TNF blockers found to cause cancer in children

enbrel 100x100The Food and Drug Administration (FDA) announced today that it has completed its analysis on a class of arthritis drugs known as tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with use of the drugs.

The analysis first came to light in early June through an early communication by the FDA, and early last month the FDA said it would require the drug makers to add a stronger warning to the black box warning currently on the products, which warns of an increased risk of malignancies but does not specifically mention leukemia. The new labeling will also add a warning of the occurrence of a new-onset psoriasis in patients treated with TNF blockers.

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Justice Dept. hits Pfizer with $2.3 billion in fines and civil penalties

pfizer hqWith the nation’s healthcare system groaning under epic pressure, you would think that the pharmaceutical giants would be a little more judicious in the way they promote their drugs and sell them to federal, state, and municipal government programs. Perhaps they will be, now that the United States Department of Justice has slapped Pfizer with a record $2.3 billion fine for defrauding the Medicare and Medicaid programs.

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FDA announces new warnings, adverse reactions on 38 drugs

fda logo 100x100Thirty-eight drugs have new labeling approved by the Food and Drug Administration (FDA) outlining new BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS and/or ADVERSE REACTIONS, according to the FDA’s MedWatch July 2009 Drug Safety Labeling Changes posting.

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Insulin syringes recalled; may pose risk to patients

syringes 150x150A type of syringe used to deliver insulin to patients with diabetes has been recalled by the manufacturer because they may pose a risk to patients, according to a notice issued by the Food and Drug Administration (FDA).

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Arthritis drugs increase risk of cancer among children

juvenile arthritisThe Food and Drug Administration (FDA) is requiring a group of popular arthritis drugs to include stronger warning of the increased risk of lymphoma and other cancers in children and adolescents treated with the medication. The warning, which follows an analysis by the FDA of tumor necrosis factor (TNF) blockers, will now be added to the black box warning currently on the products.

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Historic food safety legislation passes House

johndingell 100x100This week the House of Representatives passed legislation representing what would be the largest overhaul of the food system in American history. The measure passed the House 283 to 142 with nearly all Democrats and about half of Republicans voting in favor. The Senate is expected to review the bill in the fall after its recess.

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Body building products receive FDA warning; serious adverse reactions

px020034The Food and Drug Administration (FDA) is notifying health care professionals and their patients about dietary supplements marketed as an alternative to anabolic steroids for body building and increasing muscle mass and strength. The products are sold both online and in retail stores and promoted to athletes to improve sports performance and aid in recovery from training and sporting events. Although marketed as dietary supplements, the FDA says the products are not dietary supplements but rather unapproved new drugs that have not been reviewed by the FDA for and effectiveness.

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