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.
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.
Are you concerned about drug safety?
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/.
FDA Safety Information and Adverse Event Reporting Program Updated 35 Drug Products’ Details in December 2006
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.
Drugging America - FDA Approves Orlistat for Over-the-Counter Use
The Food and Drug Administration (FDA) approved orlistat capsules on February 7 as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version. You have to wonder at the sense in that move. It is clearly possible for people to purchase extra quantities and take a prescription-only level dose without consulting a prescriber.
OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program. Of course, if people can manage a reduced calorie diet and exercise one wonders why they need this drug, aside from making money for GlaxoSmithKline's shareholders.