Sunday, August 1, 2010

Aug2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: buprenorphine transdermal patch (Butrans) approval, leflunomide (Arava) safety warning, quinine sulfate (Qualaquin) safety warning. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Buprenorphine Transdermal System (Butrans™) – Receives FDA Approval
The FDA and Purdue Pharma, the maker of Butrans, announced a July 2010 approval of a transdermal system for the management of moderate to severe chronic pain in patients requiring continuous opioid analgesia. This unique formulation of buprenorphine — preceded by the parenteral form approved in 1981 — acts as a partial agonist at mu-opioid receptors and as an antagonist at kappa receptors. Each Butrans transdermal patch delivers continuous-release analgesia for 7 days; patches are available in 5, 10, and 20 mcg/hour strengths. Four 12-week double-blind, controlled clinical trials in both opioid-naïve and opioid-experienced patients with moderate to severe chronic low back pain or osteoarthritis helped to demonstrate Butrans’ efficacy for pain reduction. The most common adverse effects were gastrointestinal disturbances, various application-site irritations, headache, dizziness, somnolence, and dry mouth. Clinicians should visit http://www.butrans.com/ to read the Prescribing Information and Medication Guide for further details, including contraindications and precautions.

Leflunomide (Arava®) — FDA Adds Warnings
Following a post-marketing review of adverse event reports, the FDA has required an additional drug-use warning for leflunomide. The drug, used to treat rheumatoid arthritis, can increase patient risk for severe liver injury. The decision was based on a review of adverse event reports which identified 49 cases of severe liver injury, 14 of which resulted in death. The risk appears to be greater in patients with pre-existing liver disease or those who use additional drugs known to cause liver injury. Healthcare professionals are advised to assess patients thoroughly before prescribing leflunomide. For more information, see the FDA Drug Safety Communication released in July 2010.

Quinine Sulfate (Qualaquin™) — Safety Warning
The FDA issued a July 2010 warning to alert practitioners that the off-label use of Qualaquin for night-time leg cramps may result in serious and life-threatening hematological reactions. While the product is FDA-approved for the treatment of uncomplicated parasitic malaria, it has been sometimes used in the U.S. for relief of pain associated with night-time leg cramps. Adverse reactions of thrombocytopenia and hemolytic-uremic syndrome with permanent kidney damage have been reported. The FDA warns prescribers against the use of Qualaquin for unapproved uses and encourages health practitioners to alert patients to the warning signs of thrombocytopenia when prescribing for approved indications. The FDA Drug Safety Communication provides additional information.