Wednesday, October 3, 2012

Oct 2012 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: adalimumab (Humira) approved for ulcerative colitis; buprenorphine/naloxone tablet (Suboxone) production halted; topical OTC analgesics product safety alert; 2 lots of hydrocodone-acetaminophen combination tablets recalled. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Adalimumab (Humira®) – Expanded FDA Approval for Moderate to Severe Ulcerative Colitis
Abbott Laboratories announced a September 2012 U.S. Food and Drug Administration approval of Humira for adult treatment of moderate to severe ulcerative colitis (UC) in patients who were unresponsive to immunosuppressive drugs or corticosteroid therapy. Patients with UC who show evidence of clinical remission at treatment week 8 are considered good candidates for continued Humira therapy. The additional approval was based on the positive results from 2 clinical trials in more than 900 patients with ulcerative colitis. Both studies reported nearly twice the number of clinical remissions in treated participants compared with subjects in placebo groups. Humira — a tumor necrosis factor (TNF) inhibitor — was originally approved for rheumatoid arthritis in 2002 and has since received approvals for the treatment of Crohn’s disease, psoriatic arthritis, and 3 other indications. FDA representatives have expressed uncertainty regarding whether adalimumab treatment is effective for patients with moderate to severe ulcerative colitis who have had inadequate responses to other TNF inhibitors. Side effects commonly associated with Humira include infections, headache, rash, and injection site reactions. See the Humira Prescribing Information and Medication Guide for full administration and safety instructions.

Suboxone® Tablet Discontinued in Favor of Sublingual Film
Reckitt Benckiser announced in September 2012 plans to discontinue Suboxone (buprenorphine/naloxone combination) in sublingual tablet formulation during the next 6 months. Information available on the Suboxone website recommends that patients replace the tablet formulation with the sublingual film, designed to dissolve under the tongue. The manufacturer cites several reasons for the change, including improved child-safety packaging, faster dissolving rate, and more favorable taste. Additionally, the tablet formulation is now off-patent and available as a generic product. This prescription drug is used as part of a comprehensive treatment plan for opioid-dependent adults and is also used off-label for chronic pain. The sublingual film formulation contains the same dosing strengths of the 2 active ingredients, buprenorphine and naloxone (8 mg/2 mg). Complete product and safety information for Suboxone film is available in the Prescribing Information and Suboxone Medication Guide.

Skin Safety Alert – Over-the-Counter Topical Analgesics
The FDA released a September 2012 public safety communication regarding the potential for chemical burns to the skin where topical agents for relieving muscle and joint pain are applied. Several reports of first- to third-degree burns—including some requiring hospitalization—have been reported. Burns occurring within 24 hours of a single use were not uncommon. Most of the burns, categorized as second- and third-degree, occurred in people using products containing menthol as the only active agent or combination products containing both menthol (>3% concentration) and menthyl salicylate (10% concentration). A few reports involved products containing capsaicin. Over-the-counter topical creams, ointments, and patches use chemicals that provide a warm or cool sensation to the skin to relieve minor muscle and joint aches and pains but should not cause pain, swelling, or injuries to the skin. Products specifically mentioned in the safety alert included: Bengay®, Capzasin™, Flexall®, Icy Hot®, and Mentholatum®. Patients experiencing such adverse effects should stop using the product immediately and get medical advice. Healthcare professionals are encouraged to educate patients regarding the use of these products and to report adverse effects to MedWatch. See the FDA Safety Communication for more information and a MedWatch reporting form.

Product Recall — Combination Hydrocodone-Acetaminophen Tablets
In September 2012, FDA officials alerted pharmaceutical distributors, retailers, healthcare providers, and the public of a voluntary recall of 2 lots of tablets containing hydrocodone bitartrate and acetaminophen (10 mg/500 mg). Watson Laboratories product containers are marked with lot numbers 519406A or 521759A and contain an expiration date of April 2014. Tablets are marked with “Watson 540” on one side of a blue bisected capsule-shaped tablet about 0.6 inches long. The recall was initiated when it was noted that some tablets were thicker and darker than others, causing concern that one of the active ingredients could be greater than described on product packaging. Larger doses of either agent may potentially result in dangerous adverse effects. The 2 lots were distributed between June 27th and July 18th of 2012; tablets can be returned by contacting Genco Pharmaceutical Services at 800-950-5479. See the FDA Recall Announcement or contact Watson Laboratories at 800-272-5525 for additional information.

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