Re: Farmas USA
ACAD
Ataque.
Edito: nuevo artículo CNN
https://edition.cnn.com/2018/04/25/health/fda-nuplazid-safety-evaluation-invs/index.html
FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid
The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago.
"What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.
DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid.
"How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"
Re: Farmas USA
Re: Farmas USA
Re: Farmas USA
ACAD
Yo entiendo que la FDA ya contestó la semana pasada. Lo que está claro es que hay alguien esforzándose mucho por tirarla: DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid.
Creo que promediaré en cualquier momento.
When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.
The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.