The Food and Drug Administration appears to be earning its pennies this week. They have issued several warnings/recommendations that are important. I feel the need to write about the doings of the FDA because most patients will never hear about these warnings on medications that they may already be taking.

This week the FDA issued a warning concerning the possibility of severe liver injury with the use of a popular weight loss drug called orlistat. The 120mg formulation is prescription only and is marketed as Xenical and the over the counter 60mg formulation is Alli. This warning is based on reviews being done by the agency since last August and involves 13 patients with severe liver injury. Some died and some required liver transplantation.

The agency also issued a warning concerning a suicide risk with the use of tramadol. Tramadol is a pain reliever marketed as Ultram and as Ultracetwhich is tramadol with acetaminophen. It is recommended that it not be prescribed to patients who are suicidal or addiction prone and to be cautious with patients who use alcohol excessively, are depressed, or take tranquilizers or antidepressants.

The FDA also issued a recommendation that physicians exercise caution in prescribing proton pump inhibitors due to evidence that high doses or long term use of these drugs may increase the risk of various fractures. These gastroesophageal drugs include both the prescription and over the counter formulations of Prevacid, Nexium, Prilosec, and Zegerid. While the studies are not conclusive the FDA is working with the various drug manufacturers to further examine the risk.

One of the things that bothers me about the above FDA concerns is that some of these drug formulations are over the counter and there is nothing stopping patients from misusing these medications and further exposing themselves to more risk. If you are taking any of these drugs it might be wise to at least discuss it with your physician.  bjmdjd

Material modifications since posting: On May 27, 2010 Krishan Maggon PhD was kind enough to let me know via Medpedia that the Food and Drug Administration can recommend label changes on over the counter drugs so that the warning is on the package. Thanks for your contribution Dr. Maggon. bjmdjd

Food and Drug Administration · fracture risk · orlistat · proton pump inhibitors · severe liver injury · suicide risk · tramadol