Medication Monitor

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  • April 19, 2012

    FDA released a safety alert reminding patients, caregivers, and clinicians about the potential for serious adverse events, including death, resulting from accidental exposure to fentanyl patches such as Duragesic. The agency recently reviewed 26 cases of accidental exposures to the patches in pediatric patients—10 of these patients died and 12 were hospitalized. The majority (16/26) were 2 years or younger.

    FDA emphasized the importance of appropriate storage, use, application, and disposal of fentanyl patches to prevent potentially life-threatening events. Pediatric patients may be exposed to fentanyl by finding lost patches, taking improperly discarded patches from the trash, or finding improperly stored patches, all of which may result in patches being placed in their mouths or sticking to their skin. In addition, young children are at risk of fentanyl exposure when being held by someone wearing a partially detached patch, which can then transfer to the child.

    For proper disposal of the patches, FDA recommended that patients fold the adhesive side of the patch together and then flush the patch down the toilet. The agency urged health professionals to educate patients and caregivers about the appropriate use and disposal of fentanyl patches to prevent these serious errors.

  • August 8, 2014

    Cubist Pharmaceuticals is voluntarily recalling certain lots of daptomycin for injection (500 mg in 10-mL single-use vials) due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.

    The product is indicated for the treatment of skin infections and certain blood stream infections.

    The administration of a glass particulate, if present in an I.V. drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

    No complaints of glass in vial or adverse events in association with a product complaint of glass in vial have been reported to date for these recalled lots.

    Health professionals with medical questions about this recall may contact Cubist Medical Information at 877-282-4786 between 8:00 am and 5:30 pm EDT, Monday through Friday.

  • July 24, 2014

    American Health Packaging (AHP) announced a voluntary recall of ibuprofen tablets, 600 mg (lot #142588, expiration date, 01/2016) in a hospital unit dose presentation that may contain individual blistered doses labeled as oxcarbazepine tablets, 300 mg (lot #142544).

    In addition, AHP voluntarily recalled oxcarbazepine tablets, 300 mg (lot #142544, expiration date 02/2016) because a mislabeled inner unit dose blister packaging could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated.

    These hospital unit dose products were distributed nationwide beginning June 20, 2014.

    Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.

    Anyone who has received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608, 7:00 am to 5:00 pm, CST, for instructions on returning the recalled product.

    For medical information questions or product complaints related to oxcarbazepine tablets, 300 mg, or ibuprofen tablets, 600 mg, contact American Health Packaging customer service at 800-707-4621 from 8:00 am to 4:00 pm, EST.

  • May 16, 2014

    FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug eszopiclone can cause next-day impairment of driving and other activities that require alertness.

    FDA recommends a decreased starting dose of eszopiclone to 1 mg at bedtime. Women and men are equally susceptible to impairment from eszopiclone, so the recommended starting dose of 1 mg is the same for both.

    FDA approved changes to the eszopiclone prescribing information (for both the trade name Lunesta and generics), patient Medication Guide, and drug labels to include these new recommendations. 

    A study of eszopiclone found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose. Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 

    Patients should continue taking their prescribed dose of eszopiclone and contact their health professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including OTC drugs available without a prescription, and will update the public as new information becomes available.

  • January 20, 2014

    Due to sterility concerns, The Mentholatum Company is voluntarily recalling Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drops made in Vietnam.

    This recall includes ONLY lots of product that were manufactured in Vietnam and DOES NOT include eye drops made in Japan. The lot numbers for products made in Vietnam include the letter "V," for example, "Lot 3E1V," and are located on the bottom panel of the carton and on the bottom of the eye drop bottle.

    The product is sold nationwide over the counter at pharmacies and retail stores.

    The Mentholatum Company is notifying its distributors and retailers by letter to stop distribution and follow instructions in the recall letter. 

    Consumers who have questions about the recall may call 877-636-2677, Monday through Friday, 9:00 am to 5:00 pm, EST.

    No reports of injury have been associated with the products.