CHMP recommends refusal of Qsiva® (phentermine/ topiramate) marketing authorisation following re-examination

Source: European Medicines Agency Area: News Following a re-examination of a previous opinion, the Committee for Medicinal Products for Human Use (CHMP) has confirmed its recommendation to refuse the marketing authorisation for Qsiva® (phentermine and topiramate), intended for the treatment of obesity.   The CHMP noted concerns about the long-term cardiovascular effects of Qsiva® (particularly those of the phentermine component, which is known to increase heart rate). There were additionally concerns about the long-term psychiatric and cognitive effects related to the topiramate component. Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant women.   The Committee noted that there was a high probability that, if approved, the medicine would not be used strictly for the intended patients. The applicant 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® ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news

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Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Inside Schizophrenia Mental Health and Wellness Women's Issues Gender Differences Mental Disorder Mental Illness Psychiatry Psychology Psychotherapy Women's Health women's mental health Source Type: blogs
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Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Health Source Type: blogs
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Source: American Journal of Physiology. Heart and Circulatory Physiology - Category: Physiology Authors: Tags: Am J Physiol Heart Circ Physiol Source Type: research
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Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Food & Agriculture Global Headlines Health World Food Day Source Type: news
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Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
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Source: PediatricEducation.org - Category: Pediatrics Authors: Tags: Uncategorized Source Type: news
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Source: WebMD Health - Category: Consumer Health News Source Type: news
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Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized breast milk breastfeeding Trump Administration WHO Source Type: news
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Source: Drugs.com - Daily MedNews - Category: General Medicine Source Type: news
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