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The FDA recently approved hydrocodone bitartrate extended-release capsules (Zohydro ER) to help manage severe pain that requires daily, around-the-clock, long-term opioid therapy when alternative treatments don't work.
Zohydro ER is categorized as an extended-release/long-acting (ER/LA) opioid analgesic. Because of the potential for addiction, misuse, and overdose, the FDA is requiring postmarketing studies to assess the risks. The detailed labeling conforms to updated labeling requirements for all ER/LA opioid analgesics announced last September. Zohydro ER will also be included in the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy, which requires opioid manufacturers to provide medication guides, patient-teaching materials, and educational programs for healthcare professionals about ER/LA opioid analgesics. Zohydro ER isn't approved for as-needed pain relief.
Source: FDA. FDA approves extended-release, single-entity hydrocodone product. News release. October 25, 2013.
Recently approved as a new therapy for chronic hepatitis C virus (HCV) infection, simeprevir is a protease inhibitor that blocks a protein that HCV needs to replicate. Used in combination with other antiviral drugs such as peginterferon-alfa and ribavirin, it's indicated for treatment-naive and/or treatment-experienced adults with compensated liver disease, including cirrhosis.
In clinical trials, researchers noted that the drug was less effective in patients infected with HCV genotype 1a containing the Q80K polymorphism. As directed in the product labeling, healthcare providers should screen patients for this strain before starting treatment and consider alternative treatment for patients infected with this strain of HCV.
Source: FDA. FDA approves new treatment for hepatitis C virus. News release. November 22, 2013.
Animal studies have demonstrated a link between prenatal exposure to glucocorticoids (GC) and mutated brain development in offspring. To determine whether GC may have a similar effect in humans, researchers studied 37 children who'd been exposed to synthetic GC (sGC) prenatally and 185 control subjects matched by gestational age and prepregnancy body mass index. They also compared the 37 subjects with all possible controls (n = 6,079) matched by gestational age and gender.
Data were obtained from the Northern Finland Birth Cohort 1986 in four categories: pregnancy, birth, age 8, and age 16. At age 8, children's mental health was assessed by teachers using the Rutter B2 scale. At age 16, it was assessed by parents using the Strengths and Weaknesses of ADHD symptoms and Normal behavior scale. Adolescents used the Youth Self-Report scale.
Researchers found that prenatal exposure to sGC was consistently linked to adverse mental health in children and adolescents. Most significantly, prenatal sGC exposure was linked to general psychiatric disturbance and inattention at age 8.
Source: Khalife N, Glover V, Taanila A, Ebeling H, Jarvelin MR, Rodriguez A. Prenatal glucocorticoid treatment and later mental health in children and adolescents. PLoS One. 2013;8(11):e81394.
Soluble, effervescent drugs that contain sodium, such as paracetamol (known as acetaminophen in the United States), and vitamin C, increase the risk of adverse cardiovascular events when compared with matched drugs that don't contain sodium. Researchers reached this conclusion in a nested, case-controlled study of 1,292,337 patients age 18 or older who received at least two prescriptions for either sodium-containing effervescent drugs or similar sodium-free drugs between January 1987 and December 2010. They found that exposure to sodium-containing drugs was associated with "significantly increased odds of adverse cardiovascular events," including stroke, myocardial infarction, and premature death.
Many effervescent, soluble drugs are available over the counter. Researchers call for clear labeling of sodium content and encourage prescribers and patients with cardiovascular disorders who use soluble drugs to read labels and choose alternatives that are sodium-free.
Sources: George J, Majeed W, Mackenzie IS, Macdonald TM, Wei L. Association between cardiovascular events and sodium-containing, effervescent, dispersible, and soluble drugs: nested case-control study. BMJ. 2013;347:f6954. Kirby J. Drug salt content damaging health: study. Geelong Advertiser. November 27, 2013.
Previously approved to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma, sorafenib is now also indicated to treat metastatic differentiated thyroid carcinoma. This expanded use is for patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that's refractory to radioactive iodine treatment.
A clinical study of 417 patients was conducted to determine sorafenib's safety and effectiveness. Results showed that cancer progression halted for 10.8 months in patients taking sorafenib compared with 5.8 months in patients taking placebo. The most common adverse reactions to this drug were diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, weight loss, anorexia, nausea, abdominal pain, hemorrhage, and hypertension.
Healthcare providers should be aware that thyroid-stimulating hormone (TSH) is likely to increase during treatment with sorafenib, so they should monitor TSH levels monthly and adjust a patient's thyroid hormone replacement therapy as needed.
Sources: FDA. FDA approves Nexavar to treat type of thyroid cancer. Press Release. November 22, 2013.
Nexavar prescribing information. http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf.
A direct oral factor Xa inhibitor, edoxaban has proven antithrombotic effects, but how it compares with warfarin for treating patients with atrial fibrillation isn't known. A randomized, double-blind, double-dummy trial involving 21,105 patients with moderate-to-high-risk atrial fibrillation was conducted to investigate edoxaban's safety and effectiveness compared with warfarin. Patients received warfarin, high-dose edoxaban, or low-dose edoxaban once a day. The primary efficacy outcome was stroke or systemic embolism. The safety outcome was major bleeding.
Both edoxaban regimens were "noninferior" to warfarin in preventing stroke or systemic embolism, and were associated with "significantly lower rates of bleeding and death from cardiovascular causes."
Source: Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
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