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    Qsymia (phentermine / topiramate), possibility of Suicidal Behavior and Ideation


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    Thursday, July 19, 2012 11:30 am Email this article

    Here is information about Suicidal Behavior and Ideation regarding Qsymia (phentermine / topirimate) as shown in the prescribing information.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs), including topiramate, a component of Qsymia, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 

    Patients treated with Qsymia should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 

    Discontinue Qsymia in patients who experience suicidal thoughts or behaviors.

    Avoid Qsymia in patients with a history of suicidal attempts or active suicidal ideation.

    Pooled analyses of 199 placebo-controlled clinical studies (monotherapy and adjunctive therapy, median treatment duration 12 weeks) of 11 different Antiepileptic drugs across several indications showed that patients randomized to one of the Antiepileptic drugs had approximately twice the risk (adjusted Relative Risk 1.8) of suicidal thinking or behavior compared to patients randomized to placebo. 

    The estimated incidence rate of suicidal behavior or ideation among 27,863 Antiepileptic drug-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. 

    There were four suicides in Antiepileptic drug-treated patients in the trials and none in placebo treated patients, but the number is too small to allow any conclusion about Antiepileptic drugs effect on suicide.

    The increased risk of suicidal thoughts or behavior with Antiepileptic drugs was observed as early as 1 week after starting drug treatment with Antiepileptic drugs and persisted for the duration of treatment assessed. 

    Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

    The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. 

    The finding of increased risk with Antiepileptic drugs of varying mechanisms of action and across a range of indications suggests that the risk applies to all Antiepileptic drugs used for any indication. 

    The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. 

    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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