Featured Items: bupivacaine liposome injectable suspension (Exparel) approved for postsurgical pain; onabotulinumtoxinA (BOTOX) approved for chronic migraine prophylaxis; TNF Blockers, azathioprine, and/or mercaptopurine - FDA safety update; duloxetine (Cymbalta) approval denied in Europe for chronic musculoskeletal pain. — All brand names are trademarks of their respective manufacturers. Compiled by: Winnie Dawson, MA, RN, BSN.
Bupivacaine Liposome Injectable Suspension (Exparel™) — FDA Approval for Postsurgical Pain
Pacira Pharmaceuticals announced an October 2011 U.S. Food and Drug Administration approval for Exparel — a single-dose liposome injection of bupivacaine, an amide local anesthetic. When administered into the surgical site during or soon after surgery, a single infiltration provides analgesia for several days. FDA approval was based on 10 randomized, double-blind clinical trials in more than 800 patients who had various surgical procedures. The results of one placebo-controlled hemorrhoidectomy trial that was considered pivotal, demonstrated significant reductions in cumulative pain scores plus decreased opioid consumption for up to 72 hours in patients receiving Exparel. The safety of the product was evaluated in more than 1300 patients in a total of 21 clinical trials. The most commonly reported adverse effects were vomiting, nausea, and constipation. Pacira cautions healthcare providers that other formulations of bupivacaine must be withheld until 96 hours after administration of Exparel. This single-dose injectable product is contraindicated for paracervical block anesthesia in obstetrical patients. See the prescribing information [PDF here] for further administration and safety instructions.
OnabotulinumtoxinA (BOTOX®) — Approved by Health Canada for Chronic Migraine Prophylaxis
Health Canada notified Allergan, Inc. of their approval of BOTOX as a preventive treatment for chronic migraine sufferers. The product is administered by injection at 7 specific head and neck muscle sites and is designed to treat adults who experience headaches 15 days or more each month, with migraine headache on at least 8 of the total 15 days. When used as recommended, Allergan states that a patient can experience positive results lasting up to 12 weeks. Approval was based on Allergan's PREEMPT program that included almost 1,400 patients in 2 trials from 122 study sites in North America and Europe. The results of these double-blind, placebo-controlled clinical trials showed a significant decrease in headache days and total headache hours for BOTOX-treated patients compared with the placebo group. The most common adverse effects that lead to a discontinuation of BOTOX therapy were neck pain, muscular weakness, headache, and migraine. Worsening of migraine — severe enough for hospitalization — occurred in 1% of BOTOX-treated patients compared with 0.3% of placebo-treated patients. In the U.S., the FDA had approved BOTOX as a chronic migraine preventive therapy in October 2010. For complete administration and safety recommendations, read the prescribing information and medication guide [PDF here].
FDA Safety Update – TNF Blockers, Azathioprine, and/or Mercaptopurine
In a November 2011 safety communication, the FDA alerted healthcare professionals and consumers to their continuing receipt of reports of a rare white blood cell cancer in adolescents and young adults being treated with tumor necrosis factor (TNF) blockers, azathioprine, and/or mercaptopurine for Crohn’s disease or ulcerative colitis. The TNF blockers reported include infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol. The cancer of concern is Hepatosplenic T-Cell Lymphoma which is aggressive and usually fatal. The FDA report stated that most cases involved patients being treated for Crohn's disease or ulcerative colitis, but included a small number of patients being treated for rheumatoid arthritis or psoriasis. For further information, read the FDA Drug Safety Communication [here].
Duloxetine (Cymbalta®) – European Approval Denied for Chronic Musculoskeletal Pain
The Committee for Medicinal Products for Human Use (CHMP) — the European Medicines Agency — re-confirmed a prior refusal to approve duloxetine-containing medicines for the treatment of moderate to severe chronic musculoskeletal pain. The CHMP committee stated that the results of 5 studies in more than 800 patients did not show sufficient evidence that duloxetine provided a beneficial effect over time, which they felt was important in the treatment of a chronic condition. Furthermore, the committee indicated that more information was needed regarding the efficacy and safety of duloxetine for elderly patients taking duloxetine for chronic musculoskeletal pain [see more info in PDF here]. The U.S. FDA had approved duloxetine (Cymbalta®) for the treatment of chronic musculoskeletal pain, including the discomfort of osteoarthritis and chronic low back pain, in November 2010. For its approval, the FDA evaluated the results of clinical trials treating more than 600 patients and reviewed data from post-marketing studies in previously approved patient populations.