Medication Monitor

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  • March 7, 2014

    FDA is warning that doripenem, an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared with use of imipenem and cilastatin for injection (marketed in the United States under the name Primaxin).

    Based on an FDA analysis of data from a 3-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the doripenem drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doripenem is not approved to treat any type of pneumonia.

    In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day doripenem treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the doripenem arm than in the imipenem and cilastatin arm. Clinical cure rates were also lower in the doripenem arm.

    Health professionals should consider whether doripenem's benefits are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doripenem is still considered safe and effective for its FDA-approved indications: treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections.

  • October 22, 2013

    Specialty Medicine Compounding Pharmacy announced a voluntary recall of all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a hospital within Michigan. Further testing and analysis of the medication is being conducted.

    The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013. No products were distributed out of state.

    Patients should stop using the recalled product and contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT to arrange for its return. Patients should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

  • September 10, 2013

    Avella Specialty Pharmacy announced a voluntary recall of two compounded sterile medications, bevacizumab 1.25 mg/0.05 mL PF, lot #12-20130508@179; and vancomycin PF (BSS) 1%, lot #12-20130508@181. The recall is a result of concerns about sterility assurance with the pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall.

    The recalled products were dispensed directly to health care providers nationwide, and the medications can be identified based on product label and corresponding medication name and lot number.

    Patients should contact their physician or health fcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and health care providers with questions about this recall can contact Avella at 877-738-0797 Monday through Friday between 6:00 am and 6:00 pm PST, or via e-mail at

  • September 9, 2013

    Altaire Pharmaceuticals, Inc., announced a voluntary recall of nine lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so far. However, due to complaints of mold found in the 30-mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.

    A product whose preservative may not be effective could lead to the use of a contaminated product that creates a potential risk for eye infection. Altaire confirmed that all lots of product were sterile at the time of release and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. Altaire confirmed that its production facility is not the source of any reported contaminants.

    The lots were distributed between February 2012 and April 2013 nationwide at retail stores.

    The company has reformulated the product with an enhanced preservative system. All lots of the product in the 30-mL size identified with lot numbers beginning with 13 (i.e., 13000) have been made with the enhanced preservative system.

    Altaire is notifying its customers of the recall by phone and letters for further notification to retail stores. Consumers who have the product should stop use immediately and return it to the place of purchase.

    Consumers with questions can contact Altaire at 800-258-2471, Monday through Friday, from 9:00 am to 5:00 pm, ET. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the recalled product.

  • August 19, 2013

    FDA reminded health professionals about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy in Dallas, TX. FDA warned health professionals not to administer any NuVision sterile products to patients because the products’ sterility is not assured. FDA said NuVision has repeatedly declined to recall its sterile products and that the agency cannot require NuVision to undertake such recalls.

    In April 2013, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. FDA received adverse event reports of fever, flulike symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled.

    FDA said is not aware of any additional adverse event reports associated with other sterile products from NuVision.