No More Good Excuses

The alarm fulfills its function by sounding promptly at six a.m., announcing it's time for me to get up and walk. I fulfill my function by fumbling for the snooze button and hiding back under the covers. Except, these days it's not so easy to reason my way out of my morning exercise.

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.

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

Dear Heather … The Thin Commandments

Dear Heather, I like your blog and I like reading it, thanks for putting in the work to keep it updated. I hope you're doing well, I noticed you haven't been writing as much as you usually do.

Dear Heather … Need Some Creative Ideas

Dear Heather, We are looking for ways to be creative with our family fitness. We MUST do something low impact like bicycling or swimming because of previous injuries. So I am looking for creative swimming products and bicycling products that will allow all 7 of us to do something together.