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Latest From Drug Safety
After months of preparations, the European Medicines Agency’s improved pharmacovigilance database has gone live on schedule.
Given risk of serious gastrointestinal disorder, Public Citizen argues there is no reason to keep the drugs on the market when so many alternative treatments are available
Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.
Latest headlines about EpiPen cite deaths associated with product 'failures.' The attention is probably unfair, given the source (US FDA adverse event reports) but it is also inevitable given the history – and may be a warning of headlines to come if and when a generic is approved.
Generic firms might be able to purchase branded drugs for bioequivalence studies from Europe under concepts that FDA is considering. Commissioner Gottlieb says FDA may allow generic firms to seek wavier of shared REMS to avoid protracted negotiations.
Biogen is to continue to work closely with the EMA on clear guidance on how to use its MS drug Zinbryta, after the regulators recommended further restrictions on the product’s use because of the risk of liver damage. But an analyst says the restrictions are detrimental for the drug.
US FDA worries Indivior's formulation in prefilled syringes could lead to adverse events if patients obtain direct access; advisory committee to consider if REMS requiring administration by healthcare providers is adequate.
FDA expects Pain Relief Naturally to recall lidocaine-containing hemorrhoid, bed sore and pre-tattoo lotions and sprays. In addition to GMP problems, formulations and labeling for Naturally Healthy Living brand products are noncompliant with US FDA's for external analgesic OTC monograph and other agency rules.
Commercials citing non-severe side effects dilute message, London study concludes; US FDA finds price comparison claims may cause physicians to think a drug's risks are less severe and that risk info is less prominent on mobile devices.
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