Topic: U.S. Food and Drug Administration

American Heart Association says Reducing sodium in U.S. may save hundreds of thousands of lives over 10 years

February 15, 2013 |

Americans consume about 3,600 mg of sodium per day — more than twice the recommended limit.

Dallas, TX – Less sodium in the U.S. diet could save 280,000 to 500,000 lives over 10 years, according to new research in the American Heart Association journal Hypertension.

Using computer simulations and models researchers projected the effects of small (about 5 percent of a teaspoon of salt per person per day), steady annual reductions of sodium consumption in the U.S. diet, reducing sodium consumption by 40 percent to about 2,200 mg/day over 10 years. «Read the rest of this article»

FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation

December 30, 2012 |

Washington, D.C. – The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.  «Read the rest of this article»

Potentially Harmful Bacteria found in Consumer Reports Investigation of Pork Products

December 4, 2012 |

Most of the Bacteria Showed Resistance to Important Antibiotics

Yonkers, NY – In testing and analysis of pork-chop and ground-pork samples from six U.S. cities, Consumer Reports found high rates of yersinia enterocolitica, a bacterium that can cause food poisoning, especially in children.

The majority of the yersinia and as well as a substantial portion of several other bacteria detected were resistant to medically important antibiotics Consumer Reports tested.

Yersinia enterocolitica found in 69 percent of 198 pork samples tested by Consumer Reports.

«Read the rest of this article»

Tennessee Department of Health leads Statewide effort to address problem of Babies Born Dependent on Addictive Drugs

November 28, 2012 |

Nashville, TN – Weighing in at just over four pounds, one of the newest residents of Tennessee isn’t just premature, he’s dependent on addictive drugs.

Within a few hours of the delivery, hospital staff members knew by his seizures, high-pitched cries, tremors, fever and vomiting this innocent baby was another tragic case of neonatal abstinence syndrome, a condition caused when an unborn child is exposed to powerful drugs used legally or illegally by a mother during pregnancy. «Read the rest of this article»

Centers for Disease Control and Prevention Laboratory Testing and Results from the Multistate Fungal Meningitis Outbreak

November 1, 2012 |

Atlanta, GA – Centers for Disease Control and Prevention’s laboratory-confirmed results found on this page are from three New England Compounding Center (NECC) preservative-free methylprednisolone acetate (MPA) lots recalled on September 26th, 2012.

CDC’s Fungus Reference Laboratory has the capacity and technology to examine fungal isolates under the microscope and to confirm their identification using DNA sequencing methods.

Cases with Fungal Infections Linked to Steroid Injections

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Tennessee Department of Health reports FDA withdraws List of Facilities receiving New England Compounding Center due to Incorrect Data

October 23, 2012 |

FDA list used by TDH to identify 74 facilities in Tennessee receiving Suspect Materials

Clarksville’s Gateway Medical Center was in that List

Nashville, TN – The Food and Drug Administration has posted a message to its website citing some technical problems and incorrect data with a list of facilities earlier believed to have received suspect medication from the New England Compounding Center.

That list had been used by the Tennessee Department of Health and other state health departments to notify health care facilities they had received potentially unsafe injectable medications used in some eye and heart surgeries. «Read the rest of this article»

Clarksville’s Gateway Medical Center on state list of facilites receiving products suspected of a link to recent Meningitis Outbreak

October 23, 2012 |

Tennessee Department of Health names 74 Health Care Facilities receiving New England Compounding Center Products

Nashville, TN – The Tennessee Department of Health released a list of 74 health care facilities across the state that received suspect material from the New England Compounding Center after May 21st, 2012. The material includes injectable medications used in some eye and heart surgeries at the facilities.

While the Food and Drug Administration and Centers for Disease Control and Prevention have concerns that some of the NECC material used in eye and heart surgeries may have contributed to health problems in some patients, thus far no patients in Tennessee have been identified as having any issues caused by those products. «Read the rest of this article»

Multistate Fungal Meningitis Outbreak update from Centers for Disease Control and Prevention

October 21, 2012 |

Atlanta, GA – The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), is investigating a multistate fungal meningitis outbreak among patients who received contaminated steroid injections.

Several patients suffered strokes that are believed to have resulted from their infections. The investigation also includes fungal infections associated with injections in a peripheral joint, such as a knee, shoulder or ankle.

Multistate Fungal Meningitis Outbreak – Current Case Count

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Tennessee Department of Health provides support in U.S. Food and Drug Administration Alert regarding New England Compounding Center Products

October 17, 2012 |

Nashville, TN – The Tennessee Department of Health is supporting the Food and Drug Administration (FDA) in an effort to alert patients who may have been treated in Tennessee with potentially unsafe products from New England Compounding Center.

The FDA announced Monday, October 15th, its concerns about additional NECC products, including injectable ophthalmic drugs used in some eye surgeries and cardioplegic solution used in some heart surgeries after May 21st, 2012. «Read the rest of this article»

Centers for Disease Control and Prevention coordinates Multistate Meningitis Outbreak Investigation

October 6, 2012 |

Atlanta, GA – Centers for Disease Control and Prevention (CDC) is coordinating a multistate investigation of meningitis among patients who received epidural steroid injections (medication injected into the spine).

Several of these patients have had strokes related to the meningitis. In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis. This form of meningitis is not contagious.

Persons with Meningitis Linked to Epidural Steroid Injections, by State

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