Friday, February 1, 2013

Feb 2013 – Pain Product Announcements & Warnings

Pain Product AnnouncementsFeatured Items: sumatriptan iontophoretic patch (Zecuity) approved for migraine; 2 new crush-resistant strengths for oxymorphone (Opana ER); FDA warning that Rheumofan-Plus is renamed and relabeled; recall for hydrocodone-acetaminophen tablets. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Sumatriptan Iontophoretic Transdermal System (Zecuity™) – FDA Approved for Migraine
The U.S. Food and Drug Administration approved NuPathe’s Zecuity in January 2013 for the adult treatment of acute migraine attacks with or without aura. The single-use patch is applied to the upper arm or thigh and activated by a small button during a migraine episode. A battery-powered microprocessor continuously monitors skin resistance while initiating transdermal delivery of a total dose of 6.5 mg of sumatriptan during a 4-hour period. The patch was designed to provide consistent, predictable plasma sumatriptan levels while bypassing the need for gastrointestinal absorption and reducing the level of plasma concentrations seen in the injectable form.

The approval was based on 2 Phase III multi-center, randomized, placebo-controlled studies in more than 700 patients with migraine symptoms that met the International Classification of Headache Disorders II criteria — and, who used over 10,000 patches in total. The results of the larger, pivotal study reported headache resolution 2 hours post-application for 18% of participants in the treatment group versus 9% of those in the placebo group. In addition, significantly more treated patients vs placebo recipients reached secondary endpoints of headache relief at 2 hours post-treatment (53% vs 29%) and freedom from nausea after 2 hours (84% vs 63%). Additional significant gains in secondary measures realized by the treatment group vs the placebo group included freedom from photophobia and phonophobia at 2 hours, lack of need for rescue medication, and sustained headache pain relief for 2 to 24 hours post-treatment.

While the transdermal patch was well-tolerated, there were mild or moderate intensity complaints — primarily paraesthesias, pruritus, and other reactions of discomfort — at the application site by 51% of the treated participants and 45% of the placebo recipients. Trial results report that virtually no triptan-related adverse events were evident. In both trials, the 2% of participants in each group who discontinued the study complained of application site conditions, allergic contact dermatitis, nausea, and dizziness. Contraindications to the use of Zecuity include a history of varied coronary or cerebrovascular conditions, ischemic bowel disease, or the recent use of a monoamine oxidase-A inhibitor or another triptan or ergotamine agent. For all administration and safety instructions, see the Zecuity Prescribing Information which includes patient information and instructions for use.

Oxymorphone HCl (Opana ER®) – Two New Crush-Resistant Strengths
Endo Pharmaceuticals has announced the availability of 2 new Opana ER tablet strengths — 7.5 mg and 15 mg. In a related news story (PR Newswire), the company's chief operating officer Julie McHugh said "Now healthcare professionals and patients have seven strength options for extended release oxymorphone (HCl) in a version designed to be crush-resistant. We see this line completion as an important step forward for responsible pain management." As an opioid agonist, Opana ER is a Schedule II controlled substance that is indicated for the relief of moderate to severe pain in patients who require continuous analgesic therapy over an extended period of time. See the Opana ER website for images of the new dosages and read the Prescribing Information and Medication Guide for full administration and safety instructions.

FDA Safety Alert – Reumofan-Plus Dietary Supplement Renamed
The U.S. FDA announced safety concerns due to undeclared drug ingredients in a dietary supplement marketed as Reumofan-Plus in June and August of 2012 [see Pain-Topics UPDATE notice of the alert from September 2012]. Now, the FDA has released a new December 2012 warning to alert the public that Reumofan-Plus has been relabeled and is being sold under a new name – “WOW.” This product contains the same prescription-drug ingredients found in Reumofan-Plus and includes agents that could be potentially harmful. The product includes dexamethasone (a corticosteroid), diclofenac sodium (an NSAID), and methocarbamol (a muscle relaxant). Reumofan-Plus and the version relabeled as WOW are marketed as dietary supplements for pain relief as well as treatment for arthritis, osteoporosis, bone cancer, and other disorders. The FDA has received dozens of adverse event reports, many of which have had serious consequences. These ingredients may interact with other medications and can cause serious adverse effects, including liver injury, severe bleeding, corticosteroid withdrawal syndrome, stroke, and death. See the FDA Drug Safey Alert for further information, a link to the FDA’s MedWatch Adverse Event Report form, and photos of product labels.

Product Recall — Combination Hydrocodone/Acetaminophen Tablets (10 mg/500 mg)
In December 2012, Qualitest, a subsidiary of Endo Health Solutions, alerted pharmaceutical distributors, retailers, healthcare providers, and the public to a voluntary recall of 101 lots of tablets containing hydrocodone bitartrate and acetaminophen (10 mg/500 mg). The recall was initiated because it was noted that some tablets within the affected lots may weigh more than specified, causing concerns that a tablet may contain a higher dose of hydrocodone or acetaminophen than the label indicates. Larger doses of either agent could potentially result in dangerous adverse effects. The affected lots were distributed between February 20, 2012 and November 19, 2012; tablets can be returned by contacting MedTurn at 800-967-5952. See the FDA Recall Announcement for lot information and safety concerns, or contact Qualitest at 800-444-4011 with questions.

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