Medication Monitor



SORT BY:      Most Recent      Most Viewed     
List-View      Table-View
Generic Name (Trade Name—Company)
Notes
  • October 29, 2018

    FDA approved sodium oxybate for treatment of cataplexy and excessive daytime sleepiness in pediatric patients (aged 7–17 y) with narcolepsy.

    Sodium oxybate is a central nervous system (CNS) depressant approved in 2002 for treatment of cataplexy in adult patients with narcolepsy. Cataplexy is a sudden and transient episode of muscle weakness accompanied by full conscious awareness, typically triggered by emotions such as laughing, crying, or terror.

    Sodium oxybate either alone or in combination with other CNS depressants may be associated with adverse reactions that include seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Rapid onset of sedation, coupled with amnesia, particularly when combined with alcohol, has posed risks for voluntary and involuntary users (e.g., assault victims).

    The agent is contraindicated in patients being treated with sedative hypnotic agents and in patients with succinic semialdehyde dehydrogenase deficiency. In addition, patients should not drink alcohol when using Sodium oxybate. Succinic semialdehyde deficiency is a rare inborn error of metabolism variably characterized by mental retardation, hypotonia, and ataxia.

    The most common adverse reactions in pediatric patients were bed-wetting, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness. 

    The following adverse reactions have been identified during postapproval use of sodium oxybate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: joint pain, decreased appetite, fall, fluid retention, hangover, headache, hypersensitivity, hypertension, memory impairment, nocturia, panic attack, vision blurred and weight decreased.

    Because of the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion, sodium oxybate is only available through a risk evaluation mitigation strategy (REMS) programs

     

     

  • October 29, 2018

    FDA approved talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer. Patients must be selected for therapy on the basis of an FDA-approved companion diagnostic, the BRACAnalysis CDx test (Myriad Genetic Laboratories).

    Approval was based on an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

    The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo–fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite.

    The recommended talazoparib dose is 1 mg taken as a single-oral daily dose, with or without food.

  • October 25, 2018

    Promise Pharmacy is voluntarily recalling one lot (09042018@2, exp. 12/03/2018) of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile 3-mL vials in response to report of unidentified small particulate found floating in the solution.

    Potential adverse health consequences could range from limited eye irritation, inflammation, and visual impairment to permanent ocular damage with use of this eye drop solution.

    The product is used as a postsurgical (cataract) ophthalmic treatment and was distributed nationwide to individual patients.

    Promise Pharmacy is notifying its prescribers and patients by telephone and mail and is arranging for return, replacement, and refund of all recalled product.

    Patients who have product that is being recalled should stop using it and return it to Promise Pharmacy. Patients will be sent packaging with a prepaid shipping label to facilitate prompt return of product.

  • October 25, 2018

    Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme capsules in response to an FDA analysis that found the product contains sibutramine, an appetite suppressant that was withdrawn from the U.S. market because of safety concerns. The presence of sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

    Sibutramine is the active pharmaceutical ingredient in Meridia, a drug approved by FDA in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated that sibutramine poses an increased risk of heart attack and stroke. 

    Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. 

    This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via the internet through the website fatburnerszone.com.

    To date, Fat Burners Zone has not received any reports of adverse events related to this recall.

    Fat Burners Zone is notifying its distributors and customers by a recall letter sent by e-mail and is arranging for return/replacement of all recalled products.

  • October 25, 2018

    In October, Liveyon, a distributor of stem cell products manufactured by Genetech and marketed under the trade name ReGen Series, voluntarily recalled the products in response to reports of possible adverse reactions.

    Liveyon immediately discontinued the purchase of any product from Genetech and procured new product from an alternative manufacturer that has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. Liveyon stated that the new manufacturer is a U.S.-based, FDA-registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections.

    Liveyon resumed distribution of the new product line effective Monday, October 8, 2018.

Pages