Friday, February 4, 2011

Feb2011 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: fentanyl sublingual tablets (Abstral) approval; gabapentin (Gralise) approval for post-herpetic neuralgia; acetaminophen 325 mg safety limit; morphine sulfate oral solution safety alert; tocilizumab (Actemra) extended approval; buprenorphine (Butrans) now available. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Fentanyl Sublingual Tablets (Abstral™) — FDA Approved
Orexo AB and ProStrakan Group received a January 2011 U.S. Food and Drug Administration approval for Abstral, a transmucosal tablet designed to manage breakthrough pain for adult patients already receiving opioid analgesics for cancer pain. The immediate-release sublingual tablet is a rapidly disintegrating form of fentanyl citrate administered through the soft tissue of the gums, tongue, or inside of the cheek. Abstral is only available through pharmacies and healthcare professionals who are enrolled in a special Risk Evaluation and Mitigation Strategy (REMS) program. ProStrakan plans to launch 6 strengths (100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg) within the first quarter of this year. To learn more, read the medication guide or check the Abstral REMS website at

Gabapentin (Gralise™) — Approved for Post-Herpetic Neuralgia
The FDA granted Depomed a January 2011 approval of Gralise as a once-daily tablet for the treatment for post-herpetic neuralgia (PHN)/shingles. Gralise received orphan drug status because the pain of PHN — caused by nerve damage which can occur following herpes zoster infection—was difficult to manage with existing therapies. The approval came after two phase-3 trials showed that treated patients achieved a statistically significant reduction in daily pain scores when compared with patients in placebo groups. The most common adverse reactions were dizziness, somnolence, and headache; most were considered to be of mild or moderate severity. Practitioners and patients should note that Gralise is not interchangeable with other gabapentin products due to a difference in pharmacokinetic profiles and the method of administration. See Depomed announcement [here].

Acetaminophen — FDA Limits Prescription Products to 325 mg
In early January 2011, the FDA asked drug manufacturers to limit the strength of acetaminophen in each prescription drug product to 325 mg. The limit is intended for prescription acetaminophen combined with other products, such as hydrocodone or oxycodone, but not over-the-counter acetaminophen products. This limitation and the new warning notices on product labels are intended to reduce the risk of severe liver injury and allergic reactions that have been associated with acetaminophen. The FDA also reminds healthcare professionals to advise patients not to exceed the 4 gram maximum daily dose of acetaminophen and to avoid alcohol when taking acetaminophen products. Please read the Pain-Topics UPDATE and the FDA Drug Safety Communication for further information.

Morphine Sulfate Oral Solution — Safety Alert
The FDA and Roxane Laboratories have alerted healthcare professionals to reported serious adverse events, including deaths, that have resulted from accidental overdose of morphine sulfate oral solutions. The overdose incidents occurred primarily in patients who were inadvertently given the higher potency 100 mg per 5 mL (20 mg/mL) solution which is only intended for patients who are opioid tolerant. The FDA reported that most cases of overdose were caused because the morphine sulfate oral solutions that were ordered in milligrams (mg) were interchanged for milliliters (mL) by mistake. The FDA MedWatch Safety notice describes the product packaging and includes a link to prescribing information and the medication guide.

Tocilizumab (Actemra®) — Receives FDA Supplemental Approval
In January 2011, Roche reported that the FDA extended the Actemra label to include “the inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in rheumatoid arthritis.” This extended approval applies to the use of Actemra in combination with methotrexate to treat adult patients with moderately to severely active rheumatoid arthritis. Data from a phase-3 trial demonstrated that patients receiving the combination regimen had significantly less damage to their joints at one year when compared with patients in the control group. Read the updated prescribing information and medication guide for full prescribing and safety advice.

Buprenorphine Patch (Butrans™) — Now Available in U.S.
Following a July 2010 FDA approval, Purdue Pharma has announced commercial availability of Butrans beginning January 2011. Butrans transdermal system — the first opioid analgesic that delivers continuous release for 7 days — is indicated for the management of moderate to severe chronic pain in patients who require extended around-the-clock treatment. The maximum dose of this Schedule III product is 20 mcg/hour and the patch is available in 5, 10, and 20 mcg/hour strengths. Full prescribing information can be found at and the Risk Evaluation and Mitigation Strategy (REMS) program is available at