Black Box Warning

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an absolute joke it took this long for this to come out. We all have docs that have had this and we brush it under the carpet hoping no else hears of it. Vertex should be investigated
 


















I am appauled that my rep has not informed me of such events. The company knew this was going on and let me put my patients in harms way. This is what was forwarded to me from a pharmacist.

A search of the FDA Adverse Event Reporting System (AERS) database from May 23, 2011, through June 19, 2012, identified 92 cases of DRESS and 20 cases of SJS in patients taking Incivek combination treatment. The case of a 47-year-old female who continued taking Incivek combination treatment following development of DRESS was fatal. The patient developed a rash on her lower extremities after 4 weeks of triple therapy, and she continued taking all three drugs for another 4 weeks. She was hospitalized when the rash got worse. The patient developed hypotension, fever, myalgia, and acute kidney injury. She developed ventricular fibrillation and died of cardiogenic shock.
 






Anonymous said:
I am appauled that my rep has not informed me of such events. The company knew this was going on and let me put my patients in harms way. This is what was forwarded to me from a pharmacist.

A search of the FDA Adverse Event Reporting System (AERS) database from May 23, 2011, through June 19, 2012, identified 92 cases of DRESS and 20 cases of SJS in patients taking Incivek combination treatment. The case of a 47-year-old female who continued taking Incivek combination treatment following development of DRESS was fatal. The patient developed a rash on her lower extremities after 4 weeks of triple therapy, and she continued taking all three drugs for another 4 weeks. She was hospitalized when the rash got worse. The patient developed hypotension, fever, myalgia, and acute kidney injury. She developed ventricular fibrillation and died of cardiogenic shock.
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The company does nothing then the company gets sued. I hope these patients take Vertex for every dime they've made off this pig. It is not responsible to continue to promote and sell this drug
 






Helloooooo people, the direction has ALWAYS been to STOP the drug if the patient's rash became severe (a step BEFORE serious). These are patients who either weren't given good direction by their provider or who chose to ignore their provider, thus leading to serious consequences.

Vertex as a company and its representatives have always been open and upfront about the rash and have tried to educate and give clear direction on when the patient with a rash can continue to stay on therapy and when therapy should be stopped. Nothing has been hidden... get over yourselves, you Merck reps.
 






Anonymous said:
Helloooooo people, the direction has ALWAYS been to STOP the drug if the patient's rash became severe (a step BEFORE serious). These are patients who either weren't given good direction by their provider or who chose to ignore their provider, thus leading to serious consequences.

Vertex as a company and its representatives have always been open and upfront about the rash and have tried to educate and give clear direction on when the patient with a rash can continue to stay on therapy and when therapy should be stopped. Nothing has been hidden... get over yourselves, you Merck reps.
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Yeah! The nurse educator was working that patient hard! What a waste of skin that group has turned into.
 












Anonymous said:
Helloooooo people, the direction has ALWAYS been to STOP the drug if the patient's rash became severe (a step BEFORE serious). These are patients who either weren't given good direction by their provider or who chose to ignore their provider, thus leading to serious consequences.

Vertex as a company and its representatives have always been open and upfront about the rash and have tried to educate and give clear direction on when the patient with a rash can continue to stay on therapy and when therapy should be stopped. Nothing has been hidden... get over yourselves, you Merck reps.
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Always upfront? Baths to lessen rash? Potentially deadly rash? LOL. The lawsuits are going to be tremendous. Better look to bail to Gilead. Ship sinking.....
 


















Anonymous said:
Helloooooo people, the direction has ALWAYS been to STOP the drug if the patient's rash became severe (a step BEFORE serious). These are patients who either weren't given good direction by their provider or who chose to ignore their provider, thus leading to serious consequences.

Vertex as a company and its representatives have always been open and upfront about the rash and have tried to educate and give clear direction on when the patient with a rash can continue to stay on therapy and when therapy should be stopped. Nothing has been hidden... get over yourselves, you Merck reps.
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Looks like this is the only Vertex response on this post. I guess Merck has nothing else to do except troll this board. What a joke! The black box is very clear and the direction has always been clear. Try to make more of it Merck as you have tried with other things and you will continue to get no where. You aren't respected and I'm sure you will continue down that path.
 






Anonymous said:
Looks like this is the only Vertex response on this post. I guess Merck has nothing else to do except troll this board. What a joke! The black box is very clear and the direction has always been clear. Try to make more of it Merck as you have tried with other things and you will continue to get no where. You aren't respected and I'm sure you will continue down that path.
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2013 will be a very interesting year for Vertex. The beginning of the end.
 






Anonymous said:
Helloooooo people, the direction has ALWAYS been to STOP the drug if the patient's rash became severe (a step BEFORE serious). These are patients who either weren't given good direction by their provider or who chose to ignore their provider, thus leading to serious consequences.

Vertex as a company and its representatives have always been open and upfront about the rash and have tried to educate and give clear direction on when the patient with a rash can continue to stay on therapy and when therapy should be stopped. Nothing has been hidden... get over yourselves, you Merck reps.
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Hey you dumbass, SJS syndrome can go from mild to severe in a matter of hours. If you specialty sales people don't understand these types of often fatal rashes, then you never had the experience to be hired in the first place. Just goes to show what happens when a start up company hires a bunch of displaced people from another company (Wyeth) who have only perfected the skill of ass kissing.
 






And even now reps are out there downplaying the potentially deadly rash. "It was just 3 people". "It was only in china". "It was prescriber error". Do you guys realize you are putting people at risk for your market share? Do you feel good about yourselves?

And where is the FDA? They are just as much to blame.

I wonder if the executives are telling their reps to downplay the potential risk of death?
 






Don't worry, if this rash "adverse reaction" is not common with all the hep. drugs, then it will be the death of this drug because doctors will not continue to prescribe it.
 






It's important for Vertex to take the money they're making from Incivek now, and really pour it into their R&D department, which really is about expanding their cystic fibrosis franchise. We are done with Incivek, who would want to go on this drug with the new agents coming out?
 






Physicians are not feeling good about the black box warning. Now they will have to justify why they chose a product over another one that does not have this warning. Patients are not coming in now asking for Incivik. They know that their liability has just increased dramatically if they choose it.
 






Anonymous said:
Physicians are not feeling good about the black box warning. Now they will have to justify why they chose a product over another one that does not have this warning. Patients are not coming in now asking for Incivik. They know that their liability has just increased dramatically if they choose it.
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Thank you Merck for your insight. Keep playing up the terrible black box story....and then when you get a chance while you're spending your day at the mall, look at your PegIntron PI and remember you have a drug with a black box as well.
 






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