Friday, October 4, 2013
Oct 2013 – Pain Product Announcements & Warnings
Featured Items: ustekinumab (Stelara) approved for active psoriatic arthritis; fentanyl pain patch color change; new safety measures for ER/LA opioid analgesics; new 15-mcg/hour dose for buprenorphine patch (Butrans); fluoroquinolone warning of peripheral neuropathy risk; MOTRIN drops product recall; Ortiga safety warning regarding hidden drug ingredient; new warnings for Arzerra and Rituxan; bupivacaine single-dose vial recall.— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.Ustekinumab (Stelara®) – FDA Approved for Active Psoriatic Arthritis Janssen Biotech announced a September 2013 U.S. Food and Drug Administration (FDA) approval of Stelara for adult treatment of moderate to severe active psoriatic arthritis in patients who are appropriate candidates for phototherapy or systemic therapy. It is the first human interleukin antagonist (IL-12 and IL-23) therapy approved for psoriatic arthritis — a chronic autoimmune disease that can cause pain, joint inflammation, and skin lesions. . . . Stelara is administered alone, or in combination with methotrexate, as a subcutaneous injection of a 45-mg or 90-mg dose, based on patient weight. The approval was awarded following the results of two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials (PSUMMIT I and PSUMMIT II) that evaluated more than 920 patients who met the pre-established criteria for tender and swollen joints and C-reactive protein (CRP) levels in spite of previous conventional therapy. Injections were administered at week 0 and week 4, then every 12 weeks. At week 24 of the PSUMMIT I trial, 42% and 50% of patients treated with 45-mg and 90-mg respectively, met the primary endpoint for the studies. They achieved at least 20% improvement in signs and symptoms as defined by the American College of Rheumatology criteria (ACR20), as well as reports of improvements in the soft-tissue symptoms of the disease. Results of the PSUMMIT II trial were similar at week 24, with ACR20 improvements in 44% of patients receiving either 45-mg or 90-mg of Stelara.
Because Stelara can lower a person's infection-fighting power, a risk-benefit ratio should be evaluated in patients who have underlying health conditions that make them prone to infection. Allergic reactions and bacterial, viral, and fungal infections in patients taking human monoclonal antibodies have been reported to be serious, even fatal. Healthcare providers should arrange testing for latent tuberculosis before initiating treatment and should also ask patients if they are currently being treated for infection. Stelara can also result in an increased risk for certain types of cancer. For full administration and safety instructions, read the Stelara prescribing information and medication guide.
Fentanyl Pain Patch – FDA Requires a Color Change The FDA released a September 2013 safety communication announcing a decision to require a change in the color and ink durability for the printed text on the Duragesic and generic fentanyl pain patches in an effort to make them more easily identified. The safety notice also reminds healthcare practitioners and patients that used patches should be disposed of properly because they can contain enough pain medicine to be dangerous for others, including children. The decision was made in light of the deaths of 2 more children following the FDA’s pain patch safety warning delivered in April 2012. See the FDA Drug Safety Communication for further details.
ER/LA Opioid Analgesics – New Safety Measures from FDA In September 2013, the FDA released an announcement on its decision to require safety labeling changes and post-marketing study requirements for all extended-release and long-acting (ER/LA) opioid analgesics. The labeling changes, including a boxed warning on the use of these products during pregnancy, are intended to help reduce misuse, abuse, addiction, overdose and death in patients using opioid analgesic products. For an in-depth discussion on the issues surrounding these new safety measures, see the September 10th Pain-Topics UPDATE article on this topic. Also, see theFDA News Release for more information on the goals of the proposed changes.
Buprenorphine Patch (Butrans®) – New 15-Mcg/Hour Dosage Approved Purdue Pharma announced a September 2013 FDA approval of an additional 15-mcg/hour dosage strength for the Butrans Transdermal System. This opioid analgesic product delivers continuous drug release for 7 days and is indicated for the management of moderate to severe chronic pain in patients who require extended around-the-clock treatment. With 4 available strengths — 5-, 10-, 15-, and 20-mcg/hour — healthcare practitioners will have more titration options. Purdue plans to launch the new 15-mcg/hour strength in October 2013. For complete administration and safety instructions, read the product’s prescribing information and the Risk Evaluation and Mitigation Strategy (REMS) program.
FDA Safety Warning – Fluoroquinolones May Cause Peripheral Neuropathy The FDA renewed its safety warning regarding the potential for fluoroquinolone antibiotics to cause sudden and potentially permanent nerve damage. The risk of peripheral neuropathy in patients taking fluoroquinolones by mouth or injection was originally reported in 2004, but a recent FDA review revealed that existing warnings were inadequate. Peripheral neuropathy can begin within a few days of initiating fluoroquinolone treatment and may cause numbness, weakness, burning, or shooting pains that can cause long-lasting or permanent nerve damage. See the FDA Drug Safety Alert for further information, a list of approved fluoroquinolone drugs, and a link to the FDA’s MedWatch Adverse Event Report form.
Product Recall — MOTRIN Infants’ Drops Original Berry Flavor
In September 2013, McNeil Consumer Healthcare alerted pharmaceutical distributors, retailers, healthcare providers, and the public to a voluntary recall of 3 lots of 1/2 fl oz bottles of concentrated MOTRIN Infants’ Drops Original Berry Flavor. Following the release of these lots, tiny plastic particles about the size of a poppy seed were identified in a different lot of the same batch. The particles were found to be contained in the ibuprofen supplied by a third party and action has been taken to correct the situation for the future. McNeil believes that the potential for patient adverse events related to this recall are unlikely but made a decision to be extremely cautious. See the FDA Recall Announcement for additional information, including a link to the McNeil Press Release containing lot number and product information.
FDA Safety Alert – Ortiga Contains Hidden Drug Ingredient The FDA announced safety concerns for the unapproved product sold as Ortiga because it contains the prescription drug ingredient diclofenac, a non-steroidal anti-inflammatory drug (NSAID). NSAIDs can be associated with an increased risk of cardiovascular events and serious gastrointestinal damage. Diclofenac may also interact with other medications to cause serious adverse effects. The product is made in Mexico and is sold online and in retail stores. See the September 2013 FDA Drug Safety Alert for further information and a link to the FDA’s MedWatch Adverse Event Report form.
FDA Safety Notice – New Warnings for ofatumumab (Arzerra®) and rituximab (Rituxan®) The FDA issued a September 2013 announcement regarding new Boxed Warning information on the potential for the risk of reactivation of hepatitis B virus (HBV) infection in patients taking the anti-cancer drugs ofatumumab and rituximab. Rituximab has also been approved for other medical conditions, including therapy for rheumatoid arthritis. These products can impair a patient’s immune system and increase the potential for a previous HBV infection to become active again. These infections have caused serious liver disorders, including liver failure and death. New Boxed Warnings will be added to both product labels; healthcare professionals are encouraged to discuss the risks with patients. See the FDA Drug Safety Communication for additional information for healthcare practitioners and a link to the FDA’s MedWatch Adverse Event Report form.
Product Recall — Single-Dose Vials of Bupivacaine HCL Injection
In September 2013, the FDA issued a safety communication regarding 2 lots of bupivacaine HCL single-dose vials distributed by Hospira. The company received confirmed reports of foreign particulates floating or embedded in the glass vials of the following lots:
> Lot 18-136-DK – 0.25% (2.5 mg/mL) bupivacaine – distributed Aug-Sept 2012
> Lot 23-338-DK – 0.75% (7.5 mg/mL) bupivacaine – distributed Jan-May 2013
See the September 2013 FDA Safety Communication for additional information on the issues related to each individual lot and a link to the FDA’s MedWatch Adverse Event Report form.
