Drugs

Researchers Suggest FAERS Improvements

Researchers from the Novartis Institutes for Biomedical Research say that while the FDA Adverse Event Reporting System (FAERS) remains the primary source for drug postmarketing pharmacovigilance, it is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients. They attempted to correct those problems by mapping drugs to their ingredients and using natural language processing to classify and correlate drug events.

Writing in an online eLife article, they identify four key observations from their work:

much of the potential signal in FAERS and related databases is obscured by chemical name redundancy that introduces false association and hides associations that would be significant on aggregation;
FAERS reports tilt toward serious outcomes, partly owing to a confusion of adverse drug reports and outcomes;
FAERS suffers from several forms of conflation; and
once biases and conflations are corrected, the molecular mechanism of previously hidden adverse drug reports can be revealed.

An improvement that the researchers recommend is introducing automatic mapping of drugs and synonyms to ingredients, as they did in their work. “Alerts could be issued for indications where serious outcomes are comment and hard to distinguish from adverse drug reports,” they say. “Definitive drug-adverse drug report associations would require information on exposure…. The introduction of reporting automatic into FAERS would serve the dual purpose of reducing errors, such as misclassifying adverse drug reports and indications, and making the tool more interactive and rewarding for health professionals.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome