Tuesday, July 3, 2012

July 2012 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: pregabalin (Lyrica) approved for neuropathic pain in spinal cord injury; gabapentin enacarbil (Horizant) approved for postherpetic neuralgia; OPANA ER conversion to crush-resistant tablets; supplement Reumofan-Plus recalled for undeclared drugs.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Pregabalin (Lyrica® Capsules CV) - Approved for Neuropathic Pain Associated with Spinal Cord Injury
U.S. Food and Drug Administration officials gave Pfizer a June 2012 approval to market Lyrica Capsules CV for the management of neuropathic pain associated with spinal cord injury. A priority review was granted for this indication following 2 randomized, double blind trials in more than 350 patients comparing flexibly-dosed pregabalin — 150 mg/d to 600 mg/d — with placebo. The studies, which primarily treated patients with traumatic spinal cord injuries, also included a small number of nontraumatic spine-injured patients. Results showed significant reductions in neuropathic pain between baseline and trial end (12 or 16 weeks depending on the study protocol) for treated patients compared with those receiving placebo. Some treated patients experienced significant pain relief at week 1 that continued throughout the trial, and more patients receiving pregabalin reported 30% to 50% reductions in pain than placebo participants. Treatment was also associated with improved sleep and reduced anxiety. Common adverse effects for pregabalin were somnolence, dizziness, dry mouth, fatigue, and peripheral edema. Healthcare providers should advise patients that antiepileptic drugs, including pregabalin, can increase the risk of suicidal thoughts or behaviors. See the Lyrica Prescribing Information and Medication Guide for full administration and safety instructions.

Gabapentin Enacarbil (Horizant®) –Approved for Postherpetic Neuralgia
GlaxoSmithKline and Xenoport, makers of Horizant Extended-Release oral tablets, announced the June 2012 FDA approval of their extended-release gabapentin enacarbil for the adult treatment of postherpetic neuralgia. Because the pharmacokinetics of Horizant differ from other gabapentin drugs, the two products are not interchangeable. One 12-week safety and efficacy trial and 2 supportive studies in a total of 570 patients in 3 countries met primary endpoints for pain reduction. The drug is initially prescribed at 600 mg daily for 3 days, then increased to 600 mg twice daily beginning on day 4. Patients with impaired renal function must be evaluated for potential dose adjustments. The most commonly reported adverse effects were somnolence, dizziness, and headache. Dosing should be reduced for 1 week prior to discontinuation to minimize the risk of a withdrawal seizure. Healthcare providers should advise patients that antiepileptic drugs, including gabapentin enacarbil, can increase the risk of suicidal thoughts or behaviors. Horizant Extended-Release is available in 300 mg and 600 mg tablets. For complete administration and safety information, see the Medication Guide and Prescribing Information.

Opana ER – Complete Conversion to Crush-Resistant Tablets
Endo Health Solutions made a June 2012 announcement that all strengths of the original formulation of OPANA ER have been replaced by the newer crush-resistant tablet. While the tablets have been designed to resist tampering, the active ingredient oxymorphone remains the same and OPANA ER is available in 5 mg, 10 mg, 20 mg, and 30 mg dosages. The old formulation has been discontinued. The full Prescribing Information and Medication Guide can provide administration and safety data.

Reumofan-Plus Recall — Undeclared Drug Ingredient
In June 2012, the FDA notified patients and healthcare professionals that Reumofan-Plus, manufactured in Mexico by Riger Naturals, contains several active pharmaceutical ingredients not shown on the label. The product is sold in retail stores and on the internet as a dietary supplement for pain relief as well as a treatment for arthritis, osteoporosis, bone cancer and other disorders. FDA laboratory analyses identified that Reumofan-Plus contained diclofenac sodium, an NSAID, which can increase the risk of gastrointestinal bleeding, ulceration, or perforation. The product also contained methocarbamol, a muscle relaxant that can cause dizziness, low blood pressure, or enough sedation to cause mental or physical impairment. Reports of adverse effects — including liver injury, sudden changes in glucose control, leg cramps, and swelling — have been reported to the FDA in association with the use of Reumofan-Plus. Healthcare providers are encouraged to ask patients who use this product to stop using it and evaluate patients for drug interactions or adverse effects. See the Recall Announcement for additional information and a MedWatch reporting form.

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