Medication Monitor



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Generic Name (Trade Name—Company)
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  • June 15, 2019

    FDA approved galcanezumab-gnlm solution for self-injection to treat episodic cluster headache in adults. The agent was first approved in September 2018 for prevention of migraine in adults.  

    Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and 3 hours.   

    Hypersensitivity reactions with use of galcanezumab-gnlm could occur days after administration and may be prolonged. Treatment should be discontinued if this occurs. The most common adverse effect is injection site reactions.

  • June 13, 2019

    In a June 30 statement, FDA warned pregnant women and women who could become pregnant not to take dietary supplements containing vinpocetine because it is associated with adverse reproductive effects. FDA has determined that vinpocetine may cause a miscarriage or harm fetal development.

    These findings are particularly concerning because products containing vinpocetine are widely available for use by women of childbearing age. FDA is also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant.

    Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine may be referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.

    Scientists who have studied the effects of vinpocetine on pregnant animals concluded that vinpocetine decreased fetal weight and increased the chances of a miscarriage. The blood levels of vinpocetine measured in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals.

  • June 13, 2019

    FDA approved a new indication for ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. FDA initially approved ceftolozane/tazobactam in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.

    HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to CDC data, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States and are a significant issue in patients in the intensive care unit (ICU).

    Safety and efficacy of ceftolozane/tazobactam for treatment of HABP/VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared ceftolozane/tazobactam to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP. The study showed that mortality and cure rates were similar between ceftolozane/tazobactam and the comparator treatment.

    In the clinical trials, the most common adverse reactions were elevated liver enzyme levels, renal impairment or failure, and diarrhea.

    Ceftolozane/tazobactam should not be used in patients with known serious hypersensitivity to its components, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta-lactam class of antibacterial drugs.

    The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co., Inc.

  • June 13, 2019

    On May 28, 2019, FDA approved lenalidomide in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

    Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomized (1:1) to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

    The most common adverse reactions were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.

    The prescribing information includes a boxed warning alerting health professionals and patients about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal.

    The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days 1 to 21 of repeated 28-day cycles for up to 12 cycles.

  • June 13, 2019

    Allergan and Gedeon Richter announced FDA approval of cariprazine, an oral, once-daily, atypical antipsychotic, for expanded use to treat depressive episodes associated with bipolar I disorder  in adults (1.5 or 3 mg/day). Cariprazine is also approved in the United States to treat manic or mixed episodes associated with bipolar I disorder in adults (3–6 mg/d). 

    Approval for the expanded indication was based on three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale total score. In all three studies, the cariprazine 1.5-mg dose demonstrated statistical significance over placebo. In addition, in RGH-MD-54, the cariprazine 3-mg dose demonstrated statistical significance over placebo.

    Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.

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