Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
We have analysed the spontaneous report situation in Italy during 2014. As with last year, the data will be published in detail by AIFA in the OSMED Report, which will be available from next September, but in this review, we can disclose the most relevant data. In 2014, aside from over 4,000 reports in the literature, 51,181 spontaneous reports were included in the national pharmacovigilance network, with an overall increase of 25% compared to 2013.
A not rare adverse effect
Migraine is a very common ailment in the reproductive age groups, with a peak prevalence of 25% between the 30th and 40th years.1 Generally, the symptoms of migraine improve during pregnancy, and return about a month after the birth. During the breastfeeding period, environmental factors, like a lack of sleep and stress, can further aggravate the situation. In 8.4% of the women, we witness a worsening of migraine during pregnancy, which can occur as early as the first trimester.2
Last October, when I wrote an editorial for Focus Pharmacovigilance (Focus November-December 2014, page 1) about "Ebola exceptions" concerning the rules for assessing the safety and efficacy of drugs, I could never have imagined that within a few days I would find myself personally involved in the matter, and so deeply that it has almost completely absorbed me for the last six months.
May cause anesthesia gas to leak and could prevent the ventilator from
providing breathing support if not corrected immediately.
L’Agenzia Europea dei Medicinali (EMA) ha raccomandato diverse misure sul corretto degli autoiniettori di adrenalina.
Focus Farmacovigilanza è sempre stato particolarmente sensibile alla questione dei conflitti di interesse, tanto da avere introdotto un sistema di segnalazione al lettore dei possibili conflitti di interesse relativi alle fonti usate per i vari articoli. Non bisogna infatti dimenticare che Focus non è una rivista che pubblica articoli di ricerca o rassegne originali ma un bollettino che divulga notizie nel campo della farmacovigilanza e le commenta. Si tratta perciò di una rivista di letteratura terziaria, di divulgazione medico-scientifica.
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