Medication Monitor



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  • November 10, 2011

    The labeling for dabigatran has been updated to reflect new monitoring recommendations for renal function, dosing with specific drugs, and modified storage instructions. The labeling now states that renal function should be assessed before prescribing dabigatran and that renal function be reassessed in clinical situations that might be associated with declines in kidney function. In addition, for patients with a creatinine clearance (CrCl) of less than 50 mL/min or those older than 75 years of age, renal function should be assessed before treatment is initiated and at least once a year.

    The modified label also states that consideration should be given to reducing the dose of dabigatran to 75 mg twice daily for patients with moderate renal impairment (CrCl of 30 to 50 mL/min) receiving the P-glycoprotein inhibitors dronedarone or ketoconazole because of increased exposure to dabigatran.

    The updated label now states that dabigatran can be safely stored for 4 months after opening, longer than the previous recommendation to use the medication within 60 days.

  • November 9, 2011

    New information is being added to the Important Limitations of Use, Warnings and Precautions, and Medication Guide of the labeling for fenofibric acid delayed-release capsules stating that use of this drug does not lower the risk of cardiovascular (CV) events, according to an FDA safety communication. This change is a result of the agency’s review of data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, which showed that fenofibrate plus simvastatin combination therapy was associated with a nonsignificant 8% relative risk reduction in the primary composite outcome of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular disease death as compared to simvastatin plus placebo.

    In addition, a subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving combination therapy compared with simvastatin alone. At the current time, the clinical significance of this subgroup finding in women is unclear because it was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo.

    According to the announcement, FDA is requiring Abbott to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that fenofibric acid in combination with a statin versus statin alone significantly reduces the incidence of major adverse cardiovascular events in high-risk men and women who are at their LDL cholesterol goal on statin therapy but have residually high triglycerides and low HDL cholesterol.

    Patients should be given the Medication Guide that discusses these findings and educated that fenofibric acid   has not been shown to lower the risk of CV events. When deciding to prescribe the drug, health care providers should take into account the risks and benefits of therapy.

  • November 3, 2011

    Manufacturers of tumor necrosis factor (TNF) blockers will now be required to enhance safety surveillance of the risk of malignancy with use of these agents in children and young adults (30 years of age or younger), according to an FDA safety communication. Manufacturers must conduct in-depth follow-up of reports of malignancy cases in pediatric and young adult patients and submit all reports of malignancy to FDA within 15 days. In addition, the agency is requiring manufacturers to provide annual summaries and assessments of malignancies and TNF blocker utilization data. This enhanced surveillance requirement will be re-evaluated periodically by FDA over the next 10 years.

  • November 2, 2011

    Results from a recently completed retrospective study in children and young adults 2 to 24 years of age found no association between use of certain attention-deficit/hyperactivity disorder (ADHD) medications and serious cardiovascular events such as stroke, myocardial infarction, and sudden cardiac death, according to a FDA safety communication. A detailed description of this study is presented in the Psychiatry section of this website. The agency continues to recommend that health care professionals prescribe these medications according to the professional prescribing label.

  • October 27, 2011

    New data from two FDA-sponsored observational studies suggest that the risk of neuropsychiatric hospitalizations is not increased with varenicline use, according to a FDA safety update.

    The first trial found no statistically significant difference in the risk of psychiatric hospitalization for varenicline compared with nicotine replacement therapy users (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.40–1.46). These findings were confirmed in the second trial, which also found no significant difference in the risk of psychiatric hospitalization between similar groups (HR 1.13; 95% CI 0.57–2.21).

    The agency noted that although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with varenicline. The studies had various design limitations, including a sample size not large enough to detect rare events.

    FDA said that the current warnings and precautions for serious neuropsychiatric events with varenicline still apply based on postmarketing reports of changes in mood and behavior during and after varenicline use. Health care providers are advised to continue to ask patients about any history of psychiatric illness before initiating treatment with varenicline and to educate patients and caregivers to immediately stop taking the drug and contact a health professional if agitation, hostility, depressed mood, or changes in behavior or thinking or suicidal ideation/behavior are observed.

    The risk of neuropsychiatric events with varenicline will continue to be evaluated by FDA. In addition, Pfizer is currently conducting a large safety clinical trial to assess neuropsychiatric adverse events. Results are expected in 2017.

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