Category Archives: Safety

The Fort Hood Killing and Psychotropic Drugs

In response to the recent shooting at Fort Hood that killed four (including the killer’s suicide) and wounded 16, the mental health watchdog Citizens Commission on Human Rights (CCHR) views this and other recent incidents as a wake-up call to the dangers of antidepressants, anti-psychotics and anti-anxiety drugs, which between them have accumulated 22 international drug […]
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Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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Casing Cancer: ASCO Launches New Series on State of the Disease

Despite its importance as a vital indicator of overall population health status, cancer suffers from an information deficit – particularly when considered from a global perspective. The American Society of Clinical Oncology [ASCO], the lead professional group in this space, is now working to rectify at least part of the gap with the launch of […]
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Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks […]
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