Drug and therapeutics bulletin
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Tranexamic acid, an oral antifibrinolytic, is due to become available soon for purchase from pharmacies without prescription for the self-management of heavy menstrual bleeding. It is the first over-the-counter (OTC) medicine licensed specifically for this condition.1 The Medicines and Healthcare products Regulatory Agency (MHRA) views such availability of tranexamic acid (to be sold as Cyklo-F) as "an important step for women, helping improve their quality of life and providing them with the greater convenience of better access to medicines".1 Here we review the efficacy and safety of tranexamic acid and discuss whether its OTC availability is a helpful development.
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Targinact (Napp Pharmaceuticals Ltd) is a modified-release combination product containing the strong opioid oxycodone plus the opioid antagonist naloxone. It is licensed for "severe pain, which can be adequately managed only with opioid analgesics".1 The summary of product characteristics (SPC) states that "naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut". Advertising for the product claims "better pain relief", "superior GI [gastrointestinal] tolerability" and "improved quality of life" "compared to previous treatment in a clinical practice study (n=7836)". Here we consider whether Targinact offers advantages over using strong opioids plus laxatives where required.
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Around 1 in 25 of the UK population has fibromyalgia, a lifelong condition involving widespread musculoskeletal pain and tenderness, fatigue, sleep disturbance, and functional impairment, without any known structural or inflammatory cause. This problem is costly in terms of consultations, prescriptions and sick leave. The main aims of therapy are to reduce symptoms, to improve function, and to help patients adapt to the condition. Here we consider the management of adults with fibromyalgia.
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Excluding medicines, most other healthcare products are medical devices. It is estimated that around 38 million people in the UK "have contact with" a medical device every day, and there are more than 80,000 different devices on the UK market. ⋯ All but the very lowest risk devices must conform to specific European Directives. Here we look at the procedures now involved in the regulation of medical devices in the UK.
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In 2003-2005, around 9 in every 100,000 women who gave birth in the UK died through subsequent postpartum haemorrhage.1 In Africa and Asia, this complication is the commonest cause of maternal mortality, accounting for over 30% of such deaths in 1997-2002.2 These outcomes highlight the need for effective preventive and treatment strategies for postpartum haemorrhage. One possible option in this setting is the off-label use of misoprostol, a synthetic prostaglandin E1 analogue licensed for prevention and treatment of gastrointestinal ulcers. This drug is used in obstetric and gynaecological practice because of its uterotonic and cervical priming actions.3(,)4 Here we consider misoprostol as prevention of and treatment for postpartum haemorrhage.