RDEA594, an oral uric acid transporter inhibitor, is undergoing phase II clinical studies for the management of gout patients with hyperuricemia.12 In a small four-week study, 60% of patients that had elevated uric acid levels were able to achieve a level that was less than 6 mg/dL.
Tranilast, an oral mast cell stabilizer, is being studied in the United States as a uricosuric agent.13 In clinical trials it was being dosed daily as 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 900 mg, or placebo; it was mostly dosed as once daily. The twice-daily dosing had no greater efficacy. Following seven days of treatment at the three highest medication doses, mean serum urate concentrations decreased, and urinary uric acid excretion values significantly increased in treated patients. Six patients developed liver transaminase elevations; four of these reactions were in placebo-treated patients.
Safety
The Collaborating and Acting Responsibly to Ensure Safety (C.A.R.E.S.) Alliance, a patient safety organization, was launched on September 8, 2010, to help curb the problem of misuse, abuse, and unintentional overdose associated with the use of opioid medications.14 Free resources are available on their website for healthcare professionals.15,16 C.A.R.E.S. Alliance is based on the belief that the answer to effective pain management lies in education, innovation, and collaboration between healthcare professionals and patients. The mission statement of the alliance is to improve patient and societal outcomes through innovative and scientific education. Healthcare providers can download tools and resources from the website and also sign up to receive information from them.
New Approvals
Buprenorphine HCl/naloxone HCl dihydrate sublingual film (Suboxone sublingual) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid dependence.23 This sublingual formulation provides a quick-dissolving therapeutic buprenorphine dose.
Enoxaparin sodium injection (the generic of Lovenox) has been approved by the FDA.24
Oxymorphone hydrochloride extended-release tablets (the generic of Opana) in 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg strengths have been approved by the FDA.24
Lamotrigine (Lamictal) has been linked to the development of aseptic meningitis between one to 42 days after commencing therapy.17 There have been at least 40 cases in both adults in children. Thirty-five patients required hospitalization, and in most cases the symptoms resolved when lamotrigine was discontinued. Symptoms included headache, nausea, vomiting, fever, nuchal rigidity, photophobia, myalgias, and rash. Cerebrospinal fluid white blood cell count differentials showed a predominance of neutrophils in most cases. Some of these cases occurred in patients with SLE and other autoimmune disorders, and some patients developed renal and hepatic reactions, suggesting a hypersensitivity or drug reaction. The FDA is working with the drug’s manufacturer on a label update and patient medication guide.