Medication Monitor

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  • 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

  • July 13, 2011

    Global Wellness announced that it is expanding its voluntary nationwide recall of Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men to the consumer level to include lot A032111, with previous recalls covering lots 809013 and 806030. A laboratory analysis conducted by FDA found that all three lots contained sulfoaildenafil methanesulfonate, sulfosildenafil, and dimethylsildenafil analogs of sildenafil, thereby  making it an unapproved drug.

    In addition, these active drug ingredients were not listed on the product label and may interact with nitrates resulting in severe hypotension.

    The product was distributed throughout the U.S., Puerto Rico, Barbados, and Canada to internet and retail consumers.  

  • July 11, 2011


    The concentration of oseltamivir suspension will be changed from 12 mg/mL to 6 mg/mL, FDA has announced. This lower concentration is less likely to become frothy when shaken and will help with accurate measurements of the liquid, the agency said. Additional changes include the measurements on the oral dosing device, which will be switched from mg to mL; a change in the dosing table to include a column for dosing (mL) based on this new concentration; revised container and carton packaging; and compounding instructions for preparation of a 6 mg/mL oral suspension in emergency situations when the commercially marketed product is unavailable. 


    The 12 mg/mL concentration will no longer be marketed once the current supply runs out, and Genentech has instituted a voluntary Take Back Program for wholesalers, distributors, and pharmacies to remove product of the older concentration from the market. FDA notes that both concentrations may be available in the pharmacy for the 2011-12 influenza season, and health providers must be aware of this issue and to take steps to avoid medication errors as a result of confusion between the two concentrations.