Friday, October 1, 2010

Oct2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: OTC NSAID product labeling changes — stomach-bleed risk warning, pegloticase (Krystexxa) approval for gout.
— Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

OTC Analgesic & Antirheumatic Products — More Product Labeling Changes
In keeping with the FDA's decision to add "organ-specific warnings" to oral analgesic, antipyretic, and antirheumatic over-the-counter (OTC) NSAID product labels, there were several additional changes during August and September. The following product labels must now include a warning about risks of severe stomach bleeding: Aleve® capsules (naproxen sodium), Combunox™ tablets (ibuprofen and oxycodone HCl), Advil® Cold and Sinus tablets (ibuprofen and pseudoephedrine hydrochloride), Advil® Allergy Sinus caplets (ibuprofen, chlorpheniramine maleate, and pseudoephedrine), and Children's Advil® oral suspension (ibuprofen).

Pegloticase (Krystexxa™) — FDA Approved For Refractory Gout
Savient Pharmaceuticals announced the September 2010 approval of Krystexxa (pegloticase) for the treatment of gout in adult patients who have not responded to or cannot tolerate conventional drug therapies. Gout is the result of excess uric acid that can form crystals in tissues and joints to cause swelling, pain, and stiffness. Pegloticase, an enzyme, works by metabolizing uric acid to form a harmless chemical that is excreted in the urine. When administered as an intravenous infusion every two weeks as prescribed, trial data showed significant clinical improvement by reversing the course of the disease within 6 months of treatment. Due to incidents of severe allergic reaction in about 25% of cases, patients should be premedicated with a corticosteroid and an antihistamine to minimize the risk of anaphylaxis and infusion reaction. Healthcare professionals are also advised to prescribe pegloticase cautiously in patients with congestive heart failure since the drug was not studied in this population. For full information on administration and safety concerns, see the prescribing information and medication guide for Krystexxa.