Prescrire international
-
According to trials conducted in hundreds of patients with sciatica, epidural corticosteroid injections have no demonstrated efficacy beyond the placebo effect, either in the short-term or the long-term. However, they expose patients to a risk of sometimes serious neurological adverse effects.
-
Prescrire international · Nov 2012
Randomized Controlled Trial Multicenter StudyAcute coronary syndrome and rivaroxaban: not so fast...
-
Prescrire international · Feb 2015
ReviewThe reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.
Despite the fact that adverse effects are vastly under-reported, spontaneous reporting remains the foundation of pharmacovigilance. A small series of properly documented cases, when very specific, can suffice to constitute a signal. In France, reporting adverse effects to Regional Pharmacovigilance Centres (CRPVs) permits high-quality analysis of pharmacovigilance signals, so that they can be brought to the attention of the national agency responsible for making decisions about drugs, the French Health Products Agency (ANSM). ⋯ Negotiations with other Member States, the European Medicines Agency (EMA) and the European Commission must be supported by robust data: this is yet another reason for each country to have its own effective national pharmacovigilance database, the contents of which should be publicly accessible. This is unfortunately not yet the case in France in 2014. It also provides another good reason for healthcare professionals and patients to report adverse effects, so that the details can be recorded in national and European databases.
-
Prescrire international · Mar 2016
Epidural corticosteroid injections: serious neurological disorders.
The harm-benefit balance of epidural corticosteroid injections for low back pain with sciatica is unfavourable.
-
To help healthcare professionals and patients choose high-quality treatments that minimise the risk of adverse effects, in early 2017 we updated the list of drugs that Prescrire advises health pro- fessionals and patients to avoid. Prescire's assessments of the harm-benefit balance of new drugs and indications are based on a rigorous procedure that includes a systematic and reproducible literature search, identification of patient-relevant outcomes, prioritisation of the supporting data based on the strength of evidence, comparison with standard treatments, and an analysis of both known and potential adverse effects. This fifth annual review of drugs to avoid has been extended to cover all drugs examined by Prescrire between 2010 and 2016 and authorised in the European Union, whereas previous reviews only considered drugs marketed in France. ⋯ Even in serious situations, when no effective treatment exists, there is no justification for prescribing a drug with no proven efficacy that provokes severe adverse effects. It may be acceptable to test these drugs in clinical trials, but patients must be informed of the uncertainty over their harm-benefit balance, and the trial design must be relevant. Tailored supportive care is the best option when there are no available treatments capable of improving prognosis or quality of life, beyond their placebo effect.