Medication Monitor

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  • July 22, 2011

    FDA announced that the labeling for varenicline has been updated to include information about use in patients with stable cardiovascular (CV) disease and those with chronic obstructive pulmonary disease (COPD), and alternative directions that includes a modified quit date.

    Data from a randomized trial involving 700 patients with CV disease who smoked was added to the label. The results of the trial showed that use of varenicline was more effective in helping patients quit smoking and remain smoke-free for as long as 1-year compared with placebo, with only a small increased risk for CV events in this patient population. Overall, the absolute risk of CV adverse events with varenicline, in relation to its efficacy, was small.

    For COPD patients, data from a trial involving 460 patients showed that varenicline was effective for smoking cessation in this patient population with no new safety concerns identified.

    The updated label also includes an alternative quit date. Patients can start taking varenicline 7 days before their quit date, as the original label recommended, or begin varenicline and quit smoking between days 8 and 35 of treatment.  

  • July 21, 2011

    FDA said that it is continuing a review of conflicting studies on whether oral bisphosphonates used for the treatment of osteoporosis are linked to an increased risk for esophageal cancer. The agency believes at this time the benefits of this class of drugs in reducing the risk for serious fractures outweigh potential risks.

    Results from the largest two epidemiologic studies, using data from the same patient database. One study found no increased risk, but the other showed a doubling of the risk among patients who had 10 or more prescriptions or who had taken oral bisphosphonates for more than 3 years. In addition, data from other patient databases have found no increased risk or even a reduced risk.

    In its safety announcement, FDA notified providers that they have not drawn a conclusion regarding the risk of esophageal cancer and use of bisphosphonates and that there is insufficient evidence to recommend endoscopic screening of asymptomatic patients at this time. Patients should be educated on proper administration, and any adverse events should be reported.   

  • July 21, 2011

    FDA announced that it is reviewing data from the PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) study after it was stopped early because the data-monitoring committee found a 2-fold increase in the risk of death and other serious cardiovascular (CV) events in patients with permanent atrial fibrillation (AF) receiving dronedarone compared with those taking placebo.

    Specifically, a significant excess of CV events were observed in the dronedarone group for both co-primary endpoints (CV death/myocardial infarction/stroke/systemic embolism [2% vs. 0.9%, P = 0.009]; death/unplanned CV hospitalization[7.5% vs. 5.1%, P = 0.006]) as well as other CV events such as stroke (1.1% vs. 0.4%, P = 0.047) and hospitalization for heart failure (2.2% vs. 1%, P = 0.008).

    In a safety announcement, FDA said that dronedarone should not be used in patients with permanent AF and suggested that patients talk with health professionals about whether to continue use for nonpermanent AF.

  • July 18, 2011

    FDA announced that American Regent is conducting a voluntary nationwide recall of one lot of calcium gluconate injection 10% (lot no. 1006) supplied as a 100 mL Pharmacy Bulk Package, NDC #0517-3900-25, Exp. Date January 2013. The recall stems from the possibility that some of the vials may contain silicone particles. Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation. The product was distributed to wholesalers and distributors nationwide. No other sizes or lots of calcium gluconate injection are subject to this voluntary recall.


  • July 14, 2011

    Based on a review of data in the Adverse Event Reporting System (AERS) between January and March 2011, FDA has compiled a list of 14 drugs with potential signals of serious risks and/or new safety information.

    In its announcement, FDA noted that a potential safety issue has been identified, but that does not mean that a causal relationship between the drug and the listed risk has been identified.

    The medications and their associated safety risks are as follows:

    • Adalimumab (Humira): Hepatic dysfunction, failure

    • Azathioprine (Imuran): Acute febrile neutrophilic dermatosis (Sweet’s syndrome)

    • Cetuximab (Erbitux): corneal infection, ulcerative keratitis, and skin necrosis

    • Dabigatran etexilate mesylate (Pradaxa): proper storage and handling to preserve potency

    • Dronedarone HCl (Multaq): renal impairment/renal failure

    • Fibrin Sealant (Tisseel VH, Evicel): graft failure in ophthalmologic procedures and lack of efficacy in neurosurgical procedures for repair of dural tears

    • Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin): thromboembolic events wih numerous product lots

    • Iron sucrose injection (Venofer): anaphylactic reactions

    • Quinolone products: pseudotumor cerebri

    • Malathion (Ovide): burns and burning sensations

    • Mercaptopurine (Purinethol): hepatosplenic T-cell lymphoma

    • Prasugrel HCl (Effient): hypersensitivity reactions

    • Rituximab (Rituxan): hypogammaglobulinemia

    • Ropinirole HCl (Requip): medications errors as a result of similarities of product name with risperidone