February 21, 2007
Orlistat approved for OTC
On February 7, the FDA approved Orlistat for OTC sale. Sold under the Rx brand name Xenical, orlistat promotes weight loss by blocking the absorption of fat in the intestine. The medication will be sold in a starter pack containing information about how to safely use the medication.
This approval has the potential to benefit many patients who are at risk for diabetes or other complications due to their weight. However, there is also the potential for misuse by those who would use the medication for cosmetic use. By approving orlistat for OTC use, the FDA has placed an even greater responsibility on the pharmacist, who must begin to counsel patients purchasing this medication, to ensure that it is used safely by those patients who would benefit most from it.
For more information on the approval, visit http://www.fda.gov/cder/drug/infopage/orlistat_otc/index.htm
February 15, 2007
Ketek Loses Indications
Three days ago, the FDA and sanofi-aventis Pharmaceuticals agreed on a labeling change for the antibiotic Ketek (telithromycin). After reviewing reports through the FDA's MedWatch adverse event reporting system, the FDA chose to drop two of the previously reported indications: treatment of exacerbated bacterial bronchitis, and treatment of acute bacterial sinusitis. In addition, the FDA placed a boxed warning on the label contraindicating the medication in patients with myasthenia gravis, a form of muscle weakness that can be exacerbated by the medication, leading to severe respiratory depression.
While I am pleased with the fact that the MedWatch system has led to greater safety reporting, I am disturbed by the loss of another antibiotic for these two indications. With the continuing rise of drug-resistant pathogens, the health care system needs as many lines of defense as it can get. However, the ultimate solution to this problem, development of new classes of antibiotic agents, is still mostly wishful thinking. For the time being, we must continue to monitor the use of antibiotics, and use them only when necessary, and even then with moderation.
For more information about Ketek, and the change in labeling information, visit: