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  • Qsymia side effects: Anxiety in 4% of patients


    Posted by .(JavaScript must be enabled to view this email address)
    Friday, July 20, 2012 12:30 pm Email this article

    Anxiety occurred in approximately 4% of subjects given the higher dose of Qsymia (15 mg phentermine / 92 mg topiramate) versus 2% of people given a placebo according to the prescribing information for the drug.

    Mood and Sleep Disorders

    Mood and sleep disorders : Info from the prescribing info

    “The proportion of patients in 1-year controlled trials of Qsymia reporting one or more adverse reactions related to mood and sleep disorders was 15.8%, 14.5%, and 20.6% with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 10.3% with placebo,” the prescribing information notes.

    “These events were further categorized into sleep disorders, anxiety, and depression.

    “Reports of sleep disorders were typically characterized as insomnia, and occurred in 6.7%, 8.1%, and 11.1% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 5.8% of patients treated with placebo.

    “Reports of anxiety occurred in 4.6%, 4.8%, and 7.9% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 2.6% of patients treated with placebo.

    “Reports of depression/mood problems occurred in 5.0%, 3.8%, and 7.6% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and
    15 mg/92 mg, respectively, compared to 3.4% of patients treated with placebo.

    “The majority of these events first occurred within the initial 12 weeks of drug therapy; however, in some patients, events were reported later in the course of treatments.

    “In the Qsymia clinical trials, the overall prevalence of mood and sleep adverse reactions was approximately twice as great in patients with a history of depression compared to patients without a history of depression; however, the proportion of patients on active treatment versus placebo who reported mood and sleep adverse reactions was similar in these two subgroups.

    “Occurrence of depression-related events was more frequent in patients with a past history of depression across all treatment groups.

    “However, the placebo-adjusted difference in incidence of these events remained constant between groups regardless of previous depression history.”

    Info about Qseymia

    Info about Qseymia from the FDA

    The following information is from the FDA’s press release.

    “The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

    “BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories.

    “According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

    “Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

    “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

    “Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation.

    “Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet.

    “Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.”

    Reference

    Qsymia full prescribing information. July 17, 2012.
    http://www.qsymia.com/pdf/full-prescribing-information.pdf

    More Info

    More info about Qsymia here

    Drug companies website:

    Other Articles

    Other articles about Qsymia (formerly Qnexa)

    Articles on the same subject can be found here:


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