TRENDS & TECHNOLOGY
Abstract
t’s curtains for Darvon (Propoxyphene)The FDA said Friday that Xanodyne Pharmaceuticals had agreed to halt all U.S. marketing of Darvon and the related brand Darvocet, which contain the drug propoxyphene. The agency also called on generic drugmakers to stop marketing low-cost drugs containing propoxyphene. Propoxyphene, which was approved in the 1957, is an opioid narcotic used to treat mild to moderate pain. About 10 million people in the U.S. received prescriptions for Darvon and related drugs in 2009, according to the FDA. The most popular form of the drug currently is Darvocet, which combines propoxyphene with the more common painkiller acetaminophen. At an FDA meeting in 2009, officials cited studies showing most of the pain relief from Darvocet came from the acetaminophen. Other commonly prescribed drugs in the same class are oxycodone and codeine.
FDA Approves First Intravenous Formulation of AcetaminophenThe US Food and Drug Administration (FDA) has approved the first and only intravenous formulation of acetaminophen (Ofirmev; Cadence Pharmaceuticals, Inc) for the management of mild to moderate pain with or without adjunctive opioid analgesics, and the reduction of fever. FDA approval was based on data from a 3-study clinical trial program of 1020 adult and 355 pediatric patients. Intravenous acetaminophen should be administered only as a 15-minute infusion. As with other formulations of acetaminophen, the daily dose should not exceed 4 g because of the potential for potentially severe hepatotoxicity. Adverse events most commonly reported in adult clinical trials included nausea, vomiting, headache and insomnia; nausea, vomiting, constipation, pruritus, agitation, and atelectasis were most commonly reported in pediatric patients.
http://www.medscape.com/viewarticle/731994?src=mp&spon=46&uac=96018SR
Triton Infusion Pumps RecalledA voluntary nationwide recall has been issued for a total of 2018 Triton Pole Mount infusion pumps (WalkMed Infusion, LLC) because of potential errors in the door open alarm, the company said Friday in a news release. Affected devices may not alert the user to improper door closure and latching, potentially allowing pump failure to remain undetected unless tube set flow is checked before activation. Pump failure can cause a gravity feed flow condition leading to overinfusion of medication.
FDA Orders Recall of All Baxter Colleague Infusion Pumps
Problems since 1999 with the Colleague Volumetric Infusion Pumps (Baxter Healthcare Corp) have prompted the US Food and Drug Administration (FDA) to order the recall of all of an estimated 200,000 pumps currently in use. Changes made to the pumps since that time failed to satisfy the standards requested by the FDA, and a proposed correction schedule issued by the company in April 2010 indicated that the latest round of corrections would begin in May 2012 and be completed by 2013.
