Monday, March 1, 2010

March2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: tocilizumab (Actemra) approval; morphine sulfate oral solution approval; pregabalin (Lyrica) oral solution approval.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.


Tocilizumab (Actemra®) — FDA-Approved for Rheumatoid Arthritis
Genentech announced the January 2010 approval of Actemra, a once-monthly intravenous treatment for adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to tumor necrosis factor (TNF) antagonist therapies. Actemra — the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA — blocks the effects of the IL-6 immune system protein that is over-abundant in people with RA. The drug's approval was based on the results of 5 clinical trials of Actemra monotherapy or Actemra in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs). All trials reported greater improvement in treated patients’ tender-joint symptoms when compared with those of patients taking placebo. Since patients taking Actemra may have an increased risk for developing serious infections, practitioners are advised to assess each patient for infection risk and to order tuberculosis and blood tests before initiating treatment. To learn more, see the FDA press release, prescribing information, and the Actemra Medication Guide.

Morphine Sulfate Oral Solution — Roxane Receives FDA Approval
The FDA awarded a January 2010 approval of morphine sulfate oral solution to Roxane Laboratories. The company submitted a new drug application following the FDA's unapproved drugs initiative in 2009 and this product is now the only FDA-approved morphine sulfate oral solution currently available at the select concentrations. Morphine oral solution is intended for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. It is now available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL, and 100 mg per 5 mL. To improve safety, all packaging will be modified to reflect different product strengths. For additional safety information, see the Medication Guide for this product.

Pregabalin (Lyrica®) Oral Solution — Receives FDA Approval
Pfizer received a January 2010 approval of its new oral solution (20 mg/mL) formulation of Lyrica, a drug indicated for the treatment of diabetic peripheral neuropathic pain, post herpetic neuralgia, fibromyalgia, and certain types of seizures. The solution is good for 45 days after opening when stored at room temperature. Lyrica capsules are also available in 8 strengths. To learn more about administration and safety, read the Medication Guide and prescribing information.