FDA & Prescription Drugs

• Sandoz Inc.'s Drugs Miss The Mark

  Peter Wetherall | August 27, 2008 10:05 PM | 0 CommentsLas Vegas, NV

  Sandoz Inc., recently received a Warning Letter, 08-ATL-13, from the FDA, advising Sandoz that an inspection of Sandoz's manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina...

• Congress Demands Immediate Access to Clinical Data

  Peter Wetherall | August 26, 2008 10:35 PM | 0 CommentsLas Vegas, NV

  An FDA MedWatch Alert released Thursday, August 21, informed healthcare professionals that the FDA is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a...

• New England Journal of Medicine Urges the U.S. Supreme Court to be Skeptical

  Peter Wetherall | August 26, 2008 8:33 PM | 2 CommentsLas Vegas, NV

  Last week, physicians came to the aid of Plaintiff's lawyers, citizens of Clark County and the American consumer of prescription medication.    The editors of the New England Journal of Medicine...

• In Bed Together: The Potential Merger of Teva and Barr

  Peter Wetherall | August 22, 2008 8:45 AM | 0 CommentsLas Vegas, NV

  Las Vegas consumers of generic prescription medication andAmerican consumers have much to be worried about these days.   We have discussed theinefficiencies of the FDA (given its current structure...

• Akathasia: The Worst Condition of All

  Peter Wetherall | August 21, 2008 8:43 AM | 0 CommentsLas Vegas, NV

  Nearly all published literature on neurolepticdrugs documents that akathasia is the most common type of extrapyramidalsymptom resulting from the use of metoclopramide.   What is akathasia?   It is...

• Inadequate Warnings: What is all the Fuss About?

  Peter Wetherall | August 20, 2008 8:42 AM | 0 CommentsLas Vegas, NV

  The “Warnings” section of themetoclopramide label contains a discussion of the possible side effects ofextrapyramidal symptoms.  It reads: WARNINGS: Extrapyramidalsymptoms, manifested primarily as...

• Medical Literature and Advances in Science: Big Pharma Can't Read

  Peter Wetherall | August 19, 2008 8:39 AM | 0 CommentsLas Vegas, NV

      There are three ways that drugcompanies can ensure patient safety. First, of all, they can look at the adverse event reports which they arereceiving or that they get from the Food and Drug...

• Big Pharma:Too Lazy to Ensure Patient Safety?

  Peter Wetherall | August 18, 2008 6:39 PM | 0 CommentsLas Vegas, NV

  Allmanufacturers and distributors of prescription pharmaceutical products in theUnited States who hold an approved New Drug Application (hereinafter “NDA”) oran Abbreviated New Drug Application...

• Profits Over Patient Safety: Metoclopramide and Big Pharma

  Peter Wetherall | August 18, 2008 6:38 PM | 0 CommentsLas Vegas, NV

  As readers know, Reglan (the name brand) is also dispensedas Metoclopramide.  Reglan wasWyeth and Schwarz Pharma’s product.  But these two giant pharmaceutical companies aren’t the only...

• Hepatotoxicity: 35 Drug Products Require New Warnings

  Peter Wetherall | August 14, 2008 4:16 PM | 0 CommentsLas Vegas, NV

  The FDA recently posted a list of 35 drugs that required safety labeling changes.http://www.fda.gov/medwatch/safety/2008/jul08_quickview.htm  Readers know recent blogs discuss several unsafe drugs,...