Prescrire international
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Prescrire international · Aug 2008
Fentanyl by iontophoresis: new drug. Patient-controlled postoperative analgesia: continue to use intravenous morphine.
(1) A transdermal system for fentanyl, an opiate analgesic, will soon be marketed in France for patient-controlled relief of acute postoperative pain. Pushing a button delivers a dose of fentanyl (contained in a reservoir) into the general circulation by transdermal route, by means of iontophoresis, a needle-free technique; (2) The European Medicines Agency only took into account one comparative trial. This unblinded study failed to show that the efficacy of transdermal fentanyl delivered by means of iontophoresis is equal to that of intravenous morphine for patient-controlled analgesia; (3) The adverse effects of transdermal fentanyl are those of all opiates, plus cutaneous reactions at the application site; (4) This transdermal system is not particularly convenient: the device is no simpler for patients to use than a pump for intravenous administration. There is also a risk of misuse and overdose: the number of doses per push cannot be verified, there is no lockout period between two button pushes, special precautions must be taken when washing, and the used devices still contain fentanyl; (5) In practice, intravenous delivery remains the standard method of patient-controlled postoperative acute pain relief.
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(1) The traditional hot-water bottle now faces competition from a variety of similar devices, such as microwave-heated compresses and gel packs; (2) These devices can cause severe burns; (3) Microwave-heated gel packs can be harmful for two main reasons. First, microwave ovens heat deeply and unevenly and dangerous temperatures can quickly be reached. ⋯ Instructions that can be inadequate and that vary among different brands are further contributing factors; (5) These heating devices must be used with care. The recommended microwaving duration must not be exceeded, the device should be let stand for at least 10 minutes before use, and the heat-retaining material should be homogenised before applying the device to the skin.
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As with vincristine, intrathecal injection of vindesine can cause fatal or irreversible neurological lesions. In addition to adopting treatment protocols designed to keep intravenous and intrathecal administration totally separate, intravenous vindesine should be used exclusively after dilution in sufficiently large infusion bags.
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Prescrire international · Aug 2008
SSRI antidepressants and persistent pulmonary hypertension in newborns.
(1) The list of adverse effects of selective serotonin reuptake inhibitor (SSRI) antidepressants in pregnant women and their newborns continues to grow; (2) It was already known that, when taken towards the end of pregnancy, SSRIs could cause spontaneously resolving neonatal disorders, particularly neurological problems; (3) A case-control study has shown an association between maternal exposure to SSRI antidepressants after the 20th week of pregnancy and neonatal persistent pulmonary hypertension, with a 6-fold increase in the risk. Another study has provided similar results; (4) Diagnosis of depression must be made with care during pregnancy, and it should be remembered that not all patients with depression require drug therapy.