Weight Loss Community Blog

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.

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

Yes folks, you heard it right. Oral Xenical, renamed Alli will be sold at your local Walgreens or Walmart or Walwhatever convenience store you go to. This is the first, scientifically proven over the counter drug to make it to market. No prescription needed. The amount taken daily is 60 milligrams three times daily 30 minutes before a meal. As I mentioned in a previous post, this stuff is going to give you the runs, BAD. I like to take mine with an anti-diarrhea tablet. One of the side effects listed is “Oily discharge”… Thats PRETTY damn vague, don’t you think? They aren’t talking about it discharging from your nose. Now in my opinion this stuff should take off 200 calories of fat daily if taken three times. Thats not much at all, but it WILL add up. I promise. Sadly, it won’t be available till this summer. Thats when I want to be thin already.

“In the 16-week study, low-dose Xenical patients on average lost 5 percent of their baseline weight and while those receiving a placebo but following the same diet guidelines on average lost 3.3 percent. ”

Good Luck, and a prize will be awarded to the person with the cleanest underwear at the end of the day.

The US FDA MedWatch safety alert system aims to rapidly inform drug providers and consumers about updated safety information on the human healthcare products - drugs, both Rx and OTC, medical devices and diagnostics, biologics, and dietary supplements - that FDA monitors for safety following their approval. It is an important system.

The FDA intends that the information from MedWatch be concise, science-based, unbiased and clinically useful information that will help both provider and patient as they consider treatment choices. To assist both healthcare professionals and the healthcare consuming public to better understand the challenges of post-marketing drug and device surveillance and what FDA offers to address that challenge, the MedWatch Medical Director, Dr Norman S Marks, recently announce the availability of a web-based self-learning tutorial, "FDA MedWatch and Patient Safety", available at http://www.connectlive.com/events/fdamedwatch/.

Safety-related drug labeling changes for December 2006 were posted on the MedWatch on Fevruary 8, 2007. The December 2006 posting includes 35 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/2006/dec06_quickview.htm

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