Tag Archives: drug 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 […]
Posted in Safety | Also tagged , , | Leave a comment

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 […]
Posted in FDA, Gene therapy, Regulatory, Safety | Also tagged , , , | Leave a comment

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 […]
Posted in FDA, Regulatory, Safety, Supply Chain | Also tagged , , , , | Leave a comment

EU Tense as Crunch-Time for Counterfeits Approaches

By Reflector, Pharm Exec’s Brussels correspondent. Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out […]
Posted in Europe, Global, Guest Blog | Also tagged , , , , , | Leave a comment

Safety Trumps Access to Pain Meds for FDA

By Jill Wechsler, Washington Correspondent. The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to […]
Posted in Guest Blog, healthcare, Op-Ed, Regulatory, Safety | Also tagged , , | Leave a comment
  • Categories

  • Meta