Wednesday, August 1, 2012

Aug 2012 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: delayed-release prednisone (Rayos) approved for rheumatoid arthritis and 5 additional indications; generic pregabalin approved; FDA REMS approval for long-acting and extended-release opioids; makers of unapproved oxycodone products warned to stop; defective Hospira injectable vials recalled. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Delayed-Release Prednisone (Rayos®) - Approved for RA and Added Indications
U.S. Food and Drug Administration (FDA) officials gave Horizon Pharma a July 2012 approval to market Rayos delayed-release tablets for the treatment of rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma, and chronic obstructive pulmonary disease (COPD). Rayos — a proprietary low-dose delayed-release formulation of the anti-inflammatory drug prednisone — prevents the release of signaling molecules that cause inflammation in the body. Its unique pharmacokinetic design is different from immediate-release prednisone and is intended to be administered before bedtime to achieve therapeutic blood levels when cytokine levels rise during the night. Common adverse effects for prednisone are water retention, high blood sugar, increased blood pressure, increased appetite and weight gain, and unusual behavior or mood changes. Rayos can weaken a person’s immune system or cause reductions in bone density with long-term use. Because anaphylaxis has been reported on rare occasions in patients receiving corticosteroids, patients who are allergic to prednisone should not use Rayos. Horizon plans to launch the delayed-release tablet formulation in 1 mg, 2 mg, and 5 mg strengths during the fourth quarter of 2012. See the Rayos Prescribing Information for full administration and safety instructions.

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.

Hospira Injectable Products Recalled — Defective Glass Vials
In July 2012, Hospira and the FDA notified healthcare professionals of an international recall of 19 lots of 4 different drugs, including methotrexate. Glass vials in these lots were shown to have particles embedded in the neck of the vial, causing concern that patient injury could result if the particles became dislodged in the solution. The drugs involved in the recall are multiple lots of carboplatin, cytarabine, and paclitaxel, plus one lot of methotrexate in the U.S. and one lot in Canada. Hospira has not been informed of any adverse effects related to this recall but has asked anyone with products from these lots to stop use or distribution and contact them for product return and replacement. Wholesalers and retail customers with questions or defective product for return should contact Hospira Medical Communications at 800-615-0187. See the FDA recall announcement for additional information and the list of specific lots by drug name.

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