Drug Topics - August 18, 2008 - (Page 7) 7 NEWS Roundup< < < Rx Care MS drug linked to two new cases of brain disease First it was approved. Next it was withdrawn. Then it was restored to the market. Now Tysabri (natalizumab, Biogen Idec and Elan Pharmaceuticals) for multiple sclerosis has been associated with two new reports of progressive multifocal leukoencephalopathy (PML), a brain disease. The National Multiple Sclerosis Society issued a position statement about the latest development. It said, “We are encouraged that the risk management plans in place for early surveillance, such as the TOUCH program in the U.S., are doing the intended job of identifying possible cases of PML early so that patients can be treated quickly.” The organization added that the incidents highlight the need for patients to contact their health professional immediately if they experience any new and unusual symptoms. Anemia drugs to be restricted to fewer patients Erythropoiesis stimulating agents (ESAs) will bear stricter labeling and will require the distribution of a Medication Guide, following new requirements set down by the Food and Drug Administration. Among the changes are the following: • ESAs are not to be used in patients receiving chemotherapy when the expected outcome is cure. • The anemia drugs shouldn’t be given when hemoglobin levels are greater than or equal to 10 grams per deciliter. These changes were imposed by FDA under a 2007 law, which gave it the authority to order these changes, rather than negotiate with dug companies for them. This is the first time the agency has applied this law, necessitated by the fact that Amgen, maker of Aranesp and Epogen, did not agree with FDA on every revision. Amgen and Johnson and Johnson, maker of Procrit, said they would comply with these changes. DT http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2 http://www.watson.com
Table of Contents Feed for the Digital Edition of Drug Topics - August 18, 2008 Drug Topics - August 18, 2008 Contents Profitable Foot-Care Category Grows Steadily Dispelling the Myths Surrounding Lice Latest News Roundup Drug Topics - August 18, 2008 Drug Topics - August 18, 2008 - Contents (Page 1) Drug Topics - August 18, 2008 - Contents (Page 2) Drug Topics - August 18, 2008 - Profitable Foot-Care Category Grows Steadily (Page 3) Drug Topics - August 18, 2008 - Profitable Foot-Care Category Grows Steadily (Page 4) Drug Topics - August 18, 2008 - Dispelling the Myths Surrounding Lice (Page 5) Drug Topics - August 18, 2008 - Latest News Roundup (Page 6) Drug Topics - August 18, 2008 - Latest News Roundup (Page 7)
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