Pain Product Warnings August 2012

One thing this site, (updates.pain-topics.org - see link below) does very well, is keep people up to date with the latest developments in drugs that pertain to their own illness. The world of Big Pharma and governmental health departments is constantly changing and things you take for granted regarding your medications can change very quickly.

Aug 2012 – Pain Product Announcements; Warnings
Wednesday, August 1, 2012

Featured Items: generic pregabalin approved; FDA REMS approval for long-acting and extended-release opioids; makers of unapproved oxycodone products warned to stop; defective
All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Generic Pregabalin – Several Firms Receive FDA Approval     

Teva Pharmaceutical Industries, Lupin Ltd, and Watson Laboratories all received a July 2012 FDA approval of their application to produce pregabalin, the generic equivalent of Lyrica. The drug is indicated for neuropathic pain of diabetic peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia, as well as adjunctive treatment for adults experiencing partial onset seizures. The capsules will be available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths. For administration and safety information, see the pregabalin Medication Guide.

REMS Approval for Long-Acting and Extended-Release Opioids
      After 3 years in development, the FDA has approved a shared Risk Evaluation and Mitigation Strategy (REMS) for the makers of all extended-release (ER) and long-acting (LA) opioid analgesics. The program is part of the FDA’s overall plan to reduce opioid prescription abuse while providing safe access to patients who need opioids to treat moderate to severe chronic pain. The educational component of the program includes prescriber training, patient counseling information, and a medication guide for each opioid product. Healthcare professionals will learn strategies for analyzing the risks and benefits in appropriate patients, as well as techniques for monitoring and counseling patients. Read the Pain-Topics UPDATE on the REMS approval for more information and links to useful resources.

Unapproved Oxycodone Products – FDA Instructs Makers to Stop     

Consistent with the FDA’s ‘Unapproved Drugs Initiative,’ the FDA issued a July 2012 Federal Register Notice advising companies that are manufacturing and distributing unapproved oxycodone products to stop these activities. This action is intended to protect consumers from immediate-release oxycodone drug tablets, capsules, and oral solutions that have not received FDA evaluation for safety and efficacy. The manufacturers were given 45 days to cease production and 90 days to discontinue shipment of existing drugs. See the FDA News Release for questions regarding this action and a list of National Drug Code (NDC) numbers for the unapproved single-ingredient oxycodone products.

http://updates.pain-topics.org/2012/08/aug-2012-pain-product-announcements.html