Featured Items: tapentadol extended-release (Nucynta ER) approved for diabetic peripheral neuropathy; linaclotide (Linzess) capsules approved for IBS-C and Chronic Idiopathic Constipation; extended-release hydromorphone hcl (Exalgo) 32-mg strength approved; Reumofan Plus recall and updated safety warning; prefilled Carpuject hydromorphone syringe single lot recall. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.
Tapentadol (Nucynta® ER) – Added Approval for Diabetic Peripheral Neuropathy
Janssen Pharmaceuticals announced an August 2012 U.S. Food and Drug Administration (FDA) approval of their extended-release formulation of tapentadol to treat pain caused by diabetic peripheral neuropathy (DPN). Nucynta ER, a Schedule II centrally-acting synthetic analgesic originally approved in August 2011 to treat moderate to severe chronic pain, is the first opioid drug approved for neuropathic pain in DPN. Approval was based on the positive results of 2 randomized, placebo-controlled trials. Study participants who experienced a 1-point reduction in pain in their first 3 weeks of open-label treatment were randomized to 12 additional weeks on treatment or placebo. Patients in the treatment group reported significantly better pain control than those taking placebo. Adverse reactions most commonly reported were nausea, constipation, vomiting, headache, dizziness, and somnolence. See the Nucynta Prescribing Information for full administration and safety instructions.
Linaclotide (Linzess™) Capsules – Approved for IBS-C and Chronic Idiopathic Constipation
FDA officials, Ironwood Pharmaceuticals, and Forest Laboratories announced the approval of Linzess for adults aged 18 years and older to treat chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). This IBS subtype is characterized by abdominal pain and hard, lumpy stools at least 25% of the time, with loose or watery stools occurring less than 25% of the time. Linzess works in the intestines with minimal systemic exposure. Two randomized, double-blind trials in more than 1600 patients with IBS-C — receiving either 290 mcgs of Linzess or placebo for a minimum of 12 weeks — established the safety and efficacy of the drug. Two additional similar studies in more than 1200 patients with chronic idiopathic constipation were randomly assigned to Linzess dosing at 145 mcg or 290 mcg, or placebo. Because patients with chronic constipation receiving 290 mcg did not report increased effectiveness at study's end, the higher dose was not approved for that indication. Patients often reported experiencing the benefits of Linzess within a few days of treatment. Participants in both groups reported more spontaneous bowel movements, and patients with IBS-C reported reduced abdominal pain. Diarrhea was the most common adverse effect reported by treated participants. Ironwood Pharmaceuticals plans to make Linzess available during the 4th quarter of 2012. See prescribing information.
Extended-Release Hydromorphone HCl (Exalgo®) – 32 mg Strength Approved
The FDA granted an August 2012 approval of one additional dosage strength of Exalgo, an extended-release hydromorphone hydrochloride pain reliever made by Covidien. The product uses a once-daily drug delivery system developed for opioid-tolerant adult patients with moderate to severe chronic pain. Three tablet strengths — 8 mg, 12 mg, and 16 mg — were approved in March 2010; a related news story (Bloomberg BusinessWeek) reports that Covidien will make the new 32 mg tablet available within a few weeks. For full administration instructions, read the Exalgo prescribing information.
Reumofan-Plus Voluntary Recall and Updated Safety Alert – Undeclared Drug Ingredients
In August 2012, the FDA notified patients and healthcare professionals of a recall of 500 lots of Reumofan-Plus, manufactured by Samantha Lynn, Inc. A sample of Reumofan Plus — possibly containing the lot number 99515 ex096 — was found to contain methocarbamol and diclofenac. The products of concern were packaged in green bottles containing 30 round lavender tablets and sold on an internet website between February and June of 2012. No adverse events have been reported to date, but the product could cause life-threatening hypersensitivity reactions or temporary central nervous system depression. Reumofan Plus is marketed as a dietary supplement for pain relief as well as a treatment for arthritis, osteoporosis, bone cancer and other disorders. Healthcare providers are encouraged to ask patients who use this product to stop using it and evaluate patients for drug interactions or adverse effects. Samantha Lynn Inc. has stated that consumers who have purchased this product have been notified of the recall by email; questions can be addressed in an email message to the company at firstname.lastname@example.org . See the Recall Announcement for more information and a MedWatch reporting form.
In addition, the FDA issued a second warning following an earlier safety alert dated June 2012. Laboratory analysis has identified active pharmaceutical ingredients dexamethasone, diclofenac sodium, and methocarbamol in sample testing of products marketed as Reumofan Plus and Reumofan Plus Premium. Since the initial June warning, the FDA has received dozens of adverse event reports that include fatalities, stroke, liver injury, severe bleeding, sudden changes in glucose control, swelling, weight gain, leg cramps, withdrawal symptoms, and adrenal suppression. Reumofan Plus and Reumofan Plus Premium containers may be labeled in Spanish or English languages. To learn more, read the new FDA safety alert.
Product Recall — Prefilled Carpuject Hydromorphone Syringes
In August 2012, Hospira and FDA officials notified U.S. pharmaceutical retailers and healthcare professionals regarding a voluntary recall of one lot of prefilled 2.5 mL Carpuject cartridges containing 2 mg/mL hydromorphone (Lot Number 12720LL, expiration date December 1, 2013). In at least one reported case, a cartridge was found to contain more than the 1 mL labeled fill volume. Hydromorphone, an opioid medication, can produce life-threatening adverse events like respiratory depression or alterations in heart rate or pressure. The lot was distributed between March and May of 2012 but, to date, no adverse events have been reported. If inventory with this lot number is identified, do not use the product and call Stericycle at 888-973-0312 for product return information. See the FDA Recall Announcement for additional information.
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