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Although the amount of phentermine in the high phentermine dose of Qsiva is half of that currently licensed for use as a single agent in the US and the UK, the addition of topiramate was shown to increase exposure to phentermine by 40% in the PK studies .
Therefore the cardiovascular effects of Qsiva cannot be implied from data for higher doses of phentermine as a does adipex pop drug test phentermine weight loss side effects adipex 37.5 discount phentermine 37.5 single agent .
Psychiatric safety –Depression, anxiety and cognitive impairment phentermine were more commonly reported in patients treated with Qsiva than placebo .
The collection of psychiatry data with screening instruments such as QPH-9 and C-SSRS was found by CHMP to phentermine 37.5 gnc phentermine high blood pressure side effects duromine south africa adipex hcl be inadequate since diagnostic instruments are more powerful and would be needed to reliably establish the clinical relevance and magnitude of the psychiatry adverse events (AEs) observed with Qsiva .
Dropout rates for depression with Qsiva significantly outnumbered those with placebo; thus close surveillance in trials may have stopped progression to more severe phentermine symptoms .
The phentermine applicant’s claim that by applying the 3 month stopping rule for non-responders, the number of drop-outs due to neuropsychiatric AEs in the Qsiva group would not exceed those in the placebo group was questioned by CHMP .
With regard to reported cases of suicidal ideation in phentermine patients treated with Qsiva during the clinical studies, regular assessments in this regard would be required .
Another concern was the feasibility phentermine to exclude patients with moderate depression from treatment .
Overall, the availability phentermine of psychiatric expertise at sites of treatment with Qsiva was considered to be necessary by CHMP .

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