FDA sued over Serzone by consumer group
They group says the FDA did not act on a petition filed over a year ago. The petition asked that Serzone be outlawed. The group is called Public Citizen.
Serzone is banned in Europe and Canada. Australia and New Zealand are banning it as from May, 2004.
Dr. Sidney Wolfe, Public Citizen's Health Research Group said 'It is grossly negligent for the FDA to allow doctors to continue to prescribe, and patients to continue to take, Serzone.'
According to a database (of the FDA) 20 people have died of liver failure, and 55 have had liver failure as a result of taking Serzone. Generally, drug side-effects are not all reported. The total figure of illness and death is probably much higher, said Public Citizen.
Susan Cruzan, of the FDA, said that they are going to review the lawsuit. Bristol-Myers Squibb have made no comment, saying it would not be appropriate to do so during the lawsuit.
Serzone's packaging does warn patients of liver damage risks. In fact, it has a black-box warning that liver damage is a risk. In the instructions doctors are told to tell their patients about this.
In March, 2003 the group had asked for a ban on Serzone.
Public Citizen has asked the court to find the FDA's inaction with regard to the petition illegal. It wants the FDA to make a decision.
Serzone's generic name is nefazodone.
FDA dat in judecata de peste Serzone grup de consum - FDA sued over Serzone by consumer group - articole medicale engleza - startsanatate