Rest assured, this warning was already supplied to the pharmacy and patient when the prescription was issued. Looks like there may be some misdiagnosed people out there or this could be just Big Pharma. Stay educated. Know your Doctor. It's not he end of the world. "I feel Fine".
Penelope PePod said
Oct 23, 2015
Thanks, Mike. Living my life, being positive, no worries. Feels better!
wmlj1960 said
Oct 23, 2015
Penelope PePod wrote:
Seems like I'm always thanking you. You're like a knight in shining armor!
We all are Penny. Dr. Tig takes very good care of all of his patients on here. Now you do like the doctor says and live your life. Worry will do nothing but rain on your parade. Be careful on your way to Texas and ENJOY!
Penelope PePod said
Oct 23, 2015
Seems like I'm always thanking you. You're like a knight in shining armor! ..... and that's a negative on the riba rocket!
-- Edited by Penelope PePod on Friday 23rd of October 2015 06:11:55 AM
Tig said
Oct 23, 2015
Rest easy my friend! You're not driving that 12 ton Riba Rocket are you? LOL! Drive safe and don't let this get you flustered. It's going to be fine!
Penelope PePod said
Oct 23, 2015
Tig,
Paul is a Childs Pugh class A cirrhotic, so it looks like I'm worrying for nothing, as usual. Gonna try to get some sleep now. Starting our drive to Texas tomorrow morning.
Thanks again, P.
Tig said
Oct 23, 2015
Penny,
The data indicates that the possibility of adverse events in the Childs Pugh classes B and C. I'll add a link to a Medscape article that describes it in a bit more detail. I want you to remember that this isn't a warning that indicates this will cause these adverse events, but warns of the possibility and to be aware of it. While the incidence remains low, they still have to make the announcement. Chances are good that no issues will occur at all, but doctors are now being advised to watch for these potential problems in all of their cirrhotic patients, particularly the advanced cirrhotics, classes B and C. It is still indicated for administration for those considered a a Childs-Pugh class A cirrhotic. This warning adds additional monitoring for the patient with cirrhosis, that's all. The more monitoring and attention to detail is good for the patient.
"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement"
Can you define 'advanced'? My husband Paul has had cirrhosis for 10 or 15 years, portal hypertension and esophageal varices, but he is not decompensated. Do you think that would be considered advanced? I'm gonna put a call in to the PA at his doc's office right now.
Thanks, P.
Tig said
Oct 22, 2015
Here is the update AbbVie applied to their prescribing information. From their admission, it appears that it applies to those with advanced cirrhosis.
"WARNINGS AND PRECAUTIONS Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation."
The FDA just issued a warning regarding a potential risk to patients with cirrhosis (advanced fibrosis) that are taking the Abbvie drug protocols Viekira Pak and Technivie. Abbvie is updating their literature and notifying physicians of this possible adverse reaction. If you fall into this category and have questions or problems you think may be related to this, don't hesitate to contact your doctor. This states that it only applies to advanced cirrhosis. We'll keep a close eye on this.
Rest assured, this warning was already supplied to the pharmacy and patient when the prescription was issued. Looks like there may be some misdiagnosed people out there or this could be just Big Pharma. Stay educated. Know your Doctor. It's not he end of the world. "I feel Fine".
Thanks, Mike. Living my life, being positive, no worries. Feels better!
We all are Penny. Dr. Tig takes very good care of all of his patients on here.
Now you do like the doctor says and live your life. Worry will do nothing but rain on your parade. Be careful on your way to Texas and ENJOY!
Seems like I'm always thanking you. You're like a knight in shining armor! ..... and that's a negative on the riba rocket!
-- Edited by Penelope PePod on Friday 23rd of October 2015 06:11:55 AM
Rest easy my friend! You're not driving that 12 ton Riba Rocket are you? LOL! Drive safe and don't let this get you flustered. It's going to be fine!
Tig,
Paul is a Childs Pugh class A cirrhotic, so it looks like I'm worrying for nothing, as usual. Gonna try to get some sleep now. Starting our drive to Texas tomorrow morning.
Thanks again, P.
Penny,
The data indicates that the possibility of adverse events in the Childs Pugh classes B and C. I'll add a link to a Medscape article that describes it in a bit more detail. I want you to remember that this isn't a warning that indicates this will cause these adverse events, but warns of the possibility and to be aware of it. While the incidence remains low, they still have to make the announcement. Chances are good that no issues will occur at all, but doctors are now being advised to watch for these potential problems in all of their cirrhotic patients, particularly the advanced cirrhotics, classes B and C. It is still indicated for administration for those considered a a Childs-Pugh class A cirrhotic. This warning adds additional monitoring for the patient with cirrhosis, that's all. The more monitoring and attention to detail is good for the patient.
"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement"
Viekira Pak, Technivie May Up Serious Liver Injury Risk: FDA (May have to register for this Medscape site)
Tig,
Can you define 'advanced'? My husband Paul has had cirrhosis for 10 or 15 years, portal hypertension and esophageal varices, but he is not decompensated. Do you think that would be considered advanced? I'm gonna put a call in to the PA at his doc's office right now.
Thanks, P.
Here is the update AbbVie applied to their prescribing information. From their admission, it appears that it applies to those with advanced cirrhosis.
"WARNINGS AND PRECAUTIONS Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation."
HIGHLIGHTS OF PRESCRIBING INFORMATION
The FDA just issued a warning regarding a potential risk to patients with cirrhosis (advanced fibrosis) that are taking the Abbvie drug protocols Viekira Pak and Technivie. Abbvie is updating their literature and notifying physicians of this possible adverse reaction. If you fall into this category and have questions or problems you think may be related to this, don't hesitate to contact your doctor. This states that it only applies to advanced cirrhosis. We'll keep a close eye on this.
FDA warns of serious liver injury risk with AbbVie hep C drugs
FDA Warning - AbbVie