Prescrire international
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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.
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Prescrire international · Jan 2015
Vismodegib (ERIVEDGE°) In basal cell carcinoma: too many unknowns.
Basal cell carcinomas are the most common skin cancers. They are usually localised and carry a good prognosis. There is no standard treatment for the rare patients with metastatic basal cell carcinoma or very extensive basal cell carcinoma for whom surgery or radiotherapy is inappropriate. ⋯ As vismodegib enters semen, contraception is mandatory for both men (condoms) and women. In practice, vismodegib has frequent and varied adverse effects, some of which are serious, while its benefits are poorly documented. Vismodegib should only be proposed to patients in whom basal cell cancer markedly undermines quality of life, and only in the context of clinical research.
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Prescrire international · Jan 2015
Sofosbuvir (Sovaldi°). Active against hepatitis C virus, but evaluation is incomplete .
About 50% of patients with chronic hepatitis C virus (HCV) genotype 1 infection have a sustained virological response to a 48-week course of the peginterferon alfa + ribavirin combination. Adding a viral protease inhibitor to this combination for 12 to 32 weeks enhances antiviral effects but increases the risk of serious adverse effects. Between 70% and 80% of patients with HCV genotype 2 or 3 infection have a sustained virological response to a 24-week course of the peginterferon alfa + ribavirin combination. ⋯ There are many uncertainties, however, about its adverse effects and drug interactions. Adding sofosbuvir to the-peginterferon a/fa + ribavirin combination is an option for patients with genotype 1 infection,while sofosbuvir is an alternative to peginterferon a/fa for patients with genotype 2 or 3 infection. Waiting for more thorough evaluation is another reasonable option, depending on clinical status, given the slow progression of hepatitis C and the many outstanding questions concerning sofosbuvir.