News patients for better or worse. If patients have access to information, they can be more
mindful,” she adds.“Doctors don't always have the time to get full information about their …

While systematic reviews and meta-analyses are at the top of the evidence hierarchy, most
of the methodology has focused on assessing treatment benefit. Hence, we propose a …

“If someone's on 10 different medications and they have a life-threatening skin reaction, the
person who is reading [the resulting report] has no idea which of those drugs might have …

In this issue, Calapai et al. reported a potential association between oncologic adverse
reactions and interleukin-23 (IL-23) 1 inhibitor use in psoriasis patients using the …

For over 40 years, analysis of spontaneous adverse event reporting has been the
cornerstone of the drug safety surveillance system of the Food and Drug Administration …

Adverse drug reactions (ADRs) contribute to substantial morbidity and mortality and add to
rising health care costs. Many ADRs are preventable with appropriate prescribing and …

In early September, the US Food and Drug Administration (FDA) sent out a press release
posting the first quarterly report titled “Potential Signals of Serious Risks/New Safety …

UNFORTUNATELY, many health professionals do not think to report adverse events that
might be associated with medications or devices to the Food and Drug Administration (FDA) …

Abstract The Food and Drug Administration (FDA) is responsible not only for approving
drugs but also for monitoring their safety after they reach the market. The complete adverse …

Methods Four drug safety experts, who were not medical oncologists, but had experience
monitoring oncology trials independently, analyzed 50 consecutive (in terms of time of …