Thursday, September 1, 2011

Sep 2011 – Pain Product Announcements & Warnings

Announcements & Warnings Featured Items: tapentadol extended-release tablets (Nucynta) approved for chronic pain; subcutaneous abatacept (Orencia) approved for rheumatoid arthritis; citalopram hydrobromide (Celexa) safety warning. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Tapentadol-ER (Nucynta®) for Chronic Pain — FDA Approved
Janssen Pharmaceuticals announced an August 2011 U.S. Food and Drug Administration (FDA) approval for their extended-release formulation of tapentadol, Nucynta ER. This centrally-acting synthetic analgesic is a Schedule II controlled drug designed to be taken twice daily for the management of moderate to severe chronic pain in adult patients who need continuous, around-the-clock pain relief for an extended period of time. The approval was based on the results of a double-blind, randomized, placebo-controlled efficacy study and a 12-month safety trial in more than 1,100 adults with moderate to severe chronic pain. Adverse reactions most commonly reported were nausea, constipation, headache, dizziness, and somnolence. Healthcare providers are reminded that, as a mu-opioid agonist, the product carries a primary risk of respiratory depression. In addition, it is important to know that the drug is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs); and, concurrent use of tapentadol and serotonergic drugs has been reported to cause life-threatening serotonin syndrome. The drug is available in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths. Janssen’s immediate-release formulation of Nucynta was approved by the FDA in 2008. For complete administration and safety recommendations, read the Prescribing Information and Medication Guide and the Nucynta ER REMS Program documentation.

Subcutaneous Abatacept (Orencia®) — FDA Approved for Rheumatoid Arthritis
The FDA granted a July 2011 approval of Bristol-Myers Squibb’s subcutaneous formulation of Orencia for the adult treatment of moderate to severe rheumatoid arthritis (RA). The product contains a fixed 125 mg dose which is self-injected under the skin on a weekly basis, typically after a single intravenous loading dose. The approval was granted after demonstrated efficacy and safety that was comparable to the Orencia IV formulation in a total of 4 clinical trials enrolling almost 2,000 patients. Common adverse effects with either formulation included headache, nasal or pharyngeal inflammation, upper respiratory tract infection, diarrhea, and nausea. Serious infections and adverse effects were comparable in the subcutaneous and intravenous groups. Healthcare providers are cautioned not to administer Orencia concomitantly with TNF-antagonists or other biologic RA therapies, such as anakinra. For complete administration and safety recommendations, read the Prescribing Information and Patient Information (pages 1-8 and 9-14, respectively).

Citalopram Hydrobromide (Celexa) — FDA Safety Alert
In an August 2011 safety communication, the FDA alerted healthcare professionals and consumers to the increased risk of abnormal heart rhythms in patients taking high doses of Celexa. Until now, the prescribing information for the drug — a selective serotonin reuptake inhibitor (SSRI) antidepressant — has included dosing instructions suggesting that some patients may require a dose of up to 60 mg per day. Following reports of electrocardiograms showing changes in the prolongation of the QT interval and a subsequent FDA study, it appears the citalopram causes dose-dependent interval prolongation. The FDA now reports that Celexa and generic equivalents should no longer be administered in doses greater than 40 mg daily. Because a sudden discontinuation of citalopram can cause unwanted adverse effects, patients are advised to talk with their healthcare professionals before changing their dosing or stopping the product. For complete information, read the FDA Drug Safety Communication.