FDA Information - October 7, 2008

FDA Notes Two More Deaths Linked To Amylin's Diabetes Drug Byetta

August 18, 2008 - Topics diabetes, byetta, fda, hospital and pharmaceutical
Eli Lilly & Co. and Amylin Pharmaceuticals Inc.'s diabetes drug Byetta on Monday received a federal warning after the drug was linked to deaths in two patients with an inflamed pancreas and four other hospitalizations.

The U.S. Food and Drug Administration (FDA) now plans to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug. Those who died were among six Byetta users who entered the hospital since October because of a condition known as acute pancreatitis (inflammation of the pancreas with bleeding). Their Byetta treatment was stopped and the four survivors were still recovering, the FDA posted on its website

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FDA Says Controversial Plastic Inadvertently Consumed By Humans Not Harmful

August 16, 2008 - Topics fda, disease, study, legislation and food
- The controversial plastic used in baby bottles, water bottles, and to line food cans, Bisphenol-A, has been deemed safe by the Food and Drug Administration.

Concern over the effects of the plastic, especially on the very young and old, have caused a bit of a backlash against products that use BPA since U.S. government scientists at the National Toxicology Program (NTP) voiced "some" concern about they synthetic material's possible effects, which they said could include accelerated female puberty, as well as having negative effects on the mammary and prostate glands

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Tuna Salad Recalled By Stop & Shop For Fear Of Bacterial Contamination

August 12, 2008 - Topics flu, fda, food, headache and immune
Supermarket chain Shop and Stop is voluntarily recalling "Ready-to-Eat" tuna salad because it might have bacterial contamination.

On Sunday, the U.S. Food and Drug Administration (FDA) announced the recall of 4,890 pounds of Home Made and Stop and Shop tuna salad brands as there was a chance for it to be contaminated with Listeria

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FDA Approves Gilead Drug For Chronic Hepatitis B In Adults

August 11, 2008 - Topics hepatitis, fda, aids, food and dna
The U.S. Food and Drug Administration (FDA) has approved an AIDS drug made by Gilead to treat patients with hepatitis B. The drug Viread has been available in the U.S. as a treatment for HIV infection in adults since 2001.

The FDA is joining regulators in Europe, Turkey, Australia and New Zealand by allowing the drug in U.S. Generically known as tenofovir, the drug is taken in the form of a pill once daily. It works by blocking HBV DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells

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FDA Warns Cholesterol-Heart Drug Combination Can Cause Muscle Damage

August 9, 2008 - Topics fda, amiodarone and food
The U.S. Food and Drug Administration (FDA) has issued another notice to healthcare professionals when simvastatin, a common medication for high cholesterol is used in combination with amiodarone, a drug that manages irregular heart beats.

Simvastatin is the generic name for the drug. It is sold under brand names Zocor, generic Zocor, or Vytorin and should be cautiously given to patients who are also taking amiodarone, a heart rhythm drug marketed as Cordarone or Pacerone

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