Archive for February, 2007

The Ketek Story - One FDA Mistake After Another

Ketek (telithromycin) is in the news again. As usual, not for any good that it has brought. The FDA on February 12, 2007 announced yet another label change and now has removed the approval for use in two of the three areas for which it has been proescribed. That screams a clear message -- is anyone listening?

On 21 January 2006 I wrote about a Public Health Advisory from the FDA about Ketek. I noted at that time my observation that the FDA seemed interested in issuing the warning about the drug only after a respected medical journal had published some adverse findings.

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FDA Safety Information and Adverse Event Reporting Program Updated 29 Drug Products’ Details in January 2007

Safety-related drug labeling changes for January 2007 were posted on the MedWatch website on February 24.  The January 2007 posting includes 29 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

The Summary page provides drug names and a listing of the sections changed and may be accessed via the following link.

http://www.fda.gov/medwatch/SAFETY/2007/jan07_quickview.htm

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Calcium Kidney Stones – A Look

Kidney stone is a commonly found ailment these days that can come in any age group or any environment. Mostly, the kidney stones are painful that need immediate attention and proper care. Kidney stones are solid stones like the lumps within the kidneys that may move and block the urinary tract. The size and color [...]

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Struvite Kidney Stones- A Kind Of Infection Stones

Kidney stone is one of the most popular and highly problematic ailments that need proper care and treatment and attention. It has been known to be most highly painful ailments that can occur to any person. The painful attacks included in this ailment are so severe that they have been compared to the labor pains [...]

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Decrease Intake Of Animal Protein To Avoid Kidney Stones

Kidney stone is one of the most popular and highly problematic aliment that requires immediate attention and prompt action. Kidney stone has been termed as one of the highly problematic ailment that includes intensly painful attacks that tends to hamper a patient’s life to a high extent. A patient tends to get a number of [...]

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