Sunday, November 1, 2009

Nov2009 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: unapproved codeine sulfate tablet warning, fentanyl buccal film (Onsolis), colchicine (Colcrys) for gout, certolizumab pegol (Cimzia) approved for RA.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.


Unapproved Codeine Sulfate Tablets — FDA Says “Stop”
In October 2009, the FDA sent warning letters to 4 companies making or distributing unapproved codeine sulfate tablets and required a 15-day response time. The manufacturers were given 90 days to cease production and distributors have 180 days to discontinue shipment of existing drugs. The FDA reminds consumers and healthcare providers that there is no evidence that these opioid analgesic tablets are safe or effective and states that the approved codeine sulfate tablet from Roxane Laboratories is available to meet product demand. See the FDA news release for unapproved product information and company names.

Fentanyl Buccal Film (Onsolis®) for Cancer Pain — Now Available
Following FDA approval in July 2009, the makers of Onsolis — BioDelivery Sciences International and Meda Pharmaceuticals — have finalized the details of the required restricted distribution program (REMS) and the product is now commercially available. Onsolis, a new fentanyl formulation delivered through a dissolvable film that adheres to the inside of the user's cheek, was developed for opioid-tolerant adult patients with cancer. It was designed to treat breakthrough pain and offers an alternative to oral or injectable drugs by rapidly delivering a dose of pain therapy across mucous membranes. The distribution program called FOCUS™ will restrict access of Onsolis to patients, prescribers, and pharmacies registered with the program. As part of the program, education and counseling will be provided to patients and healthcare professionals. Further information is available at the FDA website "Questions and Answers About Onsolis" and the FOCUS program website. Also see prior Pain-Topics webpost [7/17/09].

Colchicine (Colcrys™) — FDA-Approved for Prevention of Gout Flares
URL Pharma announced an October 2009 FDA approval of Colcrys as prophylaxis for acute flares of gout. Two randomized trials showed a decrease in the frequency of gout flares with 0.6 mg twice-daily Colcrys dosing in patients initiating treatment with uric-acid lowering therapy. The drug — an oral form of colchicine — was first approved in July 2009 for the treatment of painful acute gout flares and has been formulated for optimal efficacy and tolerability when taken at the first sign of a flare. Because the product has a long-term history of use before approval, it is important to become familiar with new dosing recommendations; see the CenterWatch Drug Information fact sheet and the patient Medication Guide for full details. There have been reports of fatal toxicity reported in patients taking medications that interact with colchicine. For further information, please read the FDA safety information notice.

Certolizumab Pegol (Cimzia®) — Approval in Europe and the U.S.
UCB Group of Belgium has announced an October 2009 European Commission approval — following the summer U.S. FDA approval — of Cimzia for the treatment of rheumatoid arthritis in adult patients. The drug is administered as a subcutaneous injection and can be given in combination with methotrexate or as monotherapy (in cases of methotrexate intolerance) to treat the symptoms of severe active rheumatoid arthritis when DMARDS have been inadequate. It is also available in a prefilled syringe. For complete information, see the prescribing information and patient Medication Guide.