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What were the CHMP’s main concerns that led to the refusal? The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which phentermine is known to increase the heart rate but whose long-term effects are not clear .
Secondly, phentermine 37.5 mg online prescription adipex dot drug test adipex 37.5 with b12 shot over the there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component of Qsiva .
Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant phentermine women .
The Committee noted that there was a high probability that, if phentermine approved, the medicine would not be used strictly for the intended patients .
The applicant phentermine did propose measures to reduce this risk, but the measures were considered difficult to implement in practice .
Therefore, the CHMP concluded that the benefits of Qsiva did not outweigh its risks and recommended that it be refused marketing phentermine authorisation .
The phentermine CHMP refusal was confirmed after re-examination .
What consequences does this refusal have for patients in clinical trials? The company informed the CHMP that that there phentermine are no consequences for patients involved in clinical Refusal of the marketing authorisation for Qsiva (phentermine / topiramate) .

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