Friday, August 28, 2009

Aug2009 – Pain Product Announcements & Warnings

Featured Items: generic sumatriptan succinate, milnacipran (Savella), unapproved topical ibuprofen warning, tumor necrosis factor (TNF) blocker warning, extended-release morphine and naltrexone HCl (EMBEDA).
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.


Generic Sumatriptan Succinate - Receives FDA Approval
Sun Pharmaceutical Industries Ltd. reported an August 2009 FDA approval of their application for a generic version of Imitrex® for acute treatment of adult migraine attacks with and without aura. These sumatriptan succinate tablets are therapeutically equivalent to Imitrex tablets from GlaxoSmithKline.

Milnacipran HCl (Savella®) for Fibromyalgia – Now Available
Following FDA approval in January 2009, the makers of Savella — Forest Laboratories and Cypress Bioscience — have received consent to a minor post-approval cosmetic formulation change and the product is now commercially available. Savella, a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI), is the third product to receive approval for the treatment of fibromyalgia. In clinical trials, patients on milnacipran doses of 100 mg/day and 200 mg/day reported a significant improvement in pain, patient global assessment, and physical function. See prescribing information and the Savella medication guide.

Ibuprofen Topical Products – 8 Makers Receive FDA Warning for Unapproved Analgesics
Progressive Emu, Inc. and 7 other manufacturers of topical ibuprofen pain relievers received FDA warning letters during August 2009 asking them to discontinue the marketing of their products. While these over-the-counter (OTC) products are frequently marketed as “safer alternatives” to oral ibuprofen, the FDA states that “there are no approved applications for topical ibuprofen products.” See the FDA press release for a full list of products and manufacturers.

TNF Blockers Increase Risk of Childhood Cancers – FDA Requires Safety Warning
As follow-up to a June 2008 Early Communication and a year-long review, the FDA has reported their conclusion that the use of tumor necrosis factor (TNF) blockers carries an increased risk of lymphoma and other cancers for children and adolescents. These agents — marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi — are prescribed to treat juvenile idiopathic arthritis, rheumatoid arthritis, Crohn’s disease, and other immune system diseases. Patients who use the drugs for more than 2½ years appear to have an increased risk of cancer. Additionally, the FDA is requiring a safety warning regarding the increased risk of leukemia and new-onset psoriasis in all patients treated with TNF blockers. See the FDA press release and further information.

Extended-Release Morphine Sulfate and Naltrexone HCl (EMBEDA™) – FDA Approved
In August 2009, the FDA and King Pharmaceuticals, Inc. announced the approval of EMBEDA (combination extended-release morphine sulfate and naltrexone hydrochloride), a novel oral capsule for the management of moderate to severe pain. The product is intended for patients who require around-the-clock analgesia for an extended period and it is the first FDA-approved long-acting opioid that has been designed to discourage tampering by reducing drug “liking” and euphoria when crushed or chewed. EMBEDA is is scheduled to be available in September 2009 in 6 fixed-dose combinations. See prescribing information, the interim Risk Evaluation and Mitigation Strategy (REMS), and the medication guide for complete clinical and safety information. Also, see our previous blogpost on EMBEDA.