pharmacology

pharmacology

pharmacology

Reactions to the approval of lecanemab for the treatment of Alzheimer's patients in the US

The drug lecanemab (Leqembi™) has received full approval as a treatment for early Alzheimer's disease by the US Food and Drug Administration (FDA), after confirming its clinical benefit in a trial involving 1,795 patients. The FDA highlights the warning that in rare cases it can cause serious and potentially life-threatening side effects.

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Reaction: study shows Alzheimer's drug lecanemab helps neutralise the effects of small toxic amyloid aggregates

Research led by scientists at Harvard Medical School (USA) has isolated small aggregates of amyloid from the brains of post-mortem Alzheimer's patients. The achievement has made it possible to study the structure of these "clumps", which exist outside plaques and are considered highly toxic, and to test their effect on synapses. In addition, the authors have shown that the drug lecanemab, recently approved by the FDA, is able to bind to them and help neutralise their action. The results are published in the journal Neuron.

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Reaction: Study finds "major deficiencies" in cancer drug information provided to patients and doctors

Research published in The BMJ has compared the information on cancer drugs available to regulatory authorities with that officially received by doctors and patients. According to the authors, important information is often omitted. In particular, "none of the package inserts communicated information about the benefits of the drug that patients could expect based on the results of the studies". In addition, doubts raised by European evaluators about the reliability of the evidence "were rarely communicated to physicians, patients or the public," they say.

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Reaction: meta-analysis finds lack of scientific evidence on efficacy and safety of painkillers for low back pain

A meta-analysis analysing 98 published clinical trials highlights the lack of scientific evidence on the efficacy and safety of commonly used analgesic drugs for acute low back pain (such as anti-inflammatory drugs, paracetamol and opioids, among others). The study, published in The BMJ, includes data from more than 15,000 people. It concludes that there is "considerable uncertainty" about the efficacy of these drugs in reducing the severity of non-specific acute low back pain and calls on doctors and patients to use them with caution.

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Reaction: taking calcium supplements to prevent fractures is not justified in the general population

Available studies show no difference in the risk of different types of fracture between those who take calcium supplements and those who do not, according to a report by the Iberoamerican Cochrane Centre via Nutrimedia. According to the report, these supplements have side-effects and do not provide benefits in the general population and are therefore only recommended for people living in residential homes or other institutions.   

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Reactions: EMA recommends that codeine-ibuprofen combination medicines warn of possible serious harm

The European Medicines Agency (EMA) safety committee (PRAC) has recommended a change to the information on codeine-ibuprofen combination medicines to include "a warning about serious harm, including death, especially when taken for prolonged periods at higher than recommended doses". The PRAC reviewed several cases of renal, gastrointestinal and metabolic toxicity that had been reported in association with cases of abuse and dependence on these drugs.

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Reactions to study concluding that vitamin D supplementation does not reduce the risk of bone fracture in healthy adults

Research conducted on more than 25,800 healthy adults aged 50 and older in the United States concludes that taking vitamin D supplements does not reduce the risk of bone fractures. The study is published in The New England Journal of Medicine.