Delayed-release prednisone low-dose (1 mg, 2 mg, and 5 mg) known as Rayos, has been FDA approved to treat inflammatory diseases such as RA, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.9,10
Drug Safety
A group of pain experts and health officials are urging the FDA to revise prescription labels for opioid medications.11 The group members are specifically requesting that opioids only be marketed to treat severe pain and that dosing be limited to up to 100 mg daily for up to 90 days for nonmalignant pain for noncancer indications. The aim of this petition by Physicians for Responsible Opioid Prescribing is to slow aggressive marketing practices, advertisements, and medical-education programs in order to increase appropriate use of these agents.
The FDA has alerted the public that certain topical OTC analgesics to relieve mild muscle and joint pain have been reported to cause rare cases of serious skin injuries—including first-, second-, and third-degree chemical burns—on the applied areas.12 These products contain menthol, methyl salicylate, and/or capsaicin. A search of FDA’s Adverse Event Reporting System database (from 1969 through April 21, 2011), the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance database (from 2004 to 2010), and the medical literature identified 43 cases of burns on the application site from these products. Some patients required hospitalization due to burn severity. In many of the cases, the burns occurred after only one application of the product, with severe burning or blistering occurring within 24 hours of the initial use. Of the reported cases, menthol alone and the combination of menthol (>3%) and methyl salicylate (>10%), led to the majority of second- and third-degree burns. Limited cases occurred with capsaicin-containing products. When recommending OTC analgesics to patients, counsel them about how to use them appropriately and inform them about the risk of serious burns. Advise patients to discontinue using a product if they develop new pain, swelling, or skin blistering where this product was applied. If patients experience adverse drug reactions from these products, report them to the FDA MedWatch program using the voluntary reporting form 3500 at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Drug News
In late July, the Korean Food and Drug Administration (KFDA) approved Remsima (infliximab), the first antibody biosimilar to receive regulatory approval based on global clinical trials.13 It is the first anti–TNF-α to garner biosimilar approval. Approval was based on randomized, double-blinded, phase I and III studies with over 830 patients total. This study was conducted in accordance with the guidelines for biosimilar medicines by regulatory agencies including European Medicine Agency. Remsima had similar efficacy to infliximab. KFDA approved this biosimilar product for the same indications as Janssen has approved for the innovator product, which includes RA, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis. Additionally, pediatric Crohn’s disease will automatically be approved following completion of postmarketing surveillance. the rheumatologist