FDA Safety WARNING update Harvoni, Sovaldi 3-20-2015

[JimmyMose]

FDA Hepatitis Update - Important safety information: Harvoni , and Sovaldi
03/21/2015
Serious and Life-Threatening Cases of Symptomatic Bradycardia as well as One Case of Fatal Cardiac Arrest Reported with Coadministration of amiodarone with either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or with Sovaldi® (sofosbuvir) in combination with another direct acting antiviral.

On March 20, 2015, FDA approved changes to the Harvoni (ledipasvir/sofosbuvir fixed dose combination) and Sovaldi (sofosbuvir) labels to update the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DRUG INTERATIONS sections of the labeling and the patient package insert with information on post-marketing cases of symptomatic bradycardia when co-administered with amiodarone. Additionally, Gilead Sciences has issued a Dear Healthcare Provider letter

http://shopping-advise-tips.blogspot.com/2015/03/us-food-drug-administration-fda-daily_21.html

[Dee1956]

I just saw this again, I wanted to bump it up just in case there are newbies here who did not see this.  Sorry if it annoys anyone.

[Carlhcv]

I just saw your posts. I cut and split wood all winter for heat. That helps me to stay in shape too. I'm doing OK on week 7 but starting to get fatigued and short of breath easy. I am approved for 24 weeks but will consider stopping at 12 since I was und at 4 weeks. Don't anyone be fooled, Harvoni is a powerful drug and was rushed onto the market minimal studies. It seems to work but who knows what long term effects may show up. Look what happened with Vioxx and Darvocet recently.

[Dee1956]

sorry Carl, my southern roots came through yesterday morning.
I hope you are doing well.
I had an EKG before starting tx the first time.  It was a trial so that might have been a prerequisite, then during the 48 weeks they did EKG's at regular intervals.
My best to you
Dee

[Dee1956]

Carl! God love you! Don't try to have a heart attack.  Chopping wood?  I spit my coffee out laughing when I read that.
We would like you to stay around for a long while.

I can see the head lines now, man has massive heart attack chopping wood to check his blood pressure.

[JimmyMose]

I have CAD 4 stents Aug 2014.  Before I started SOV/RBV last year I was given an EKG and my hepNP listened to my heart at each visit.  Had no problems otherwise would have had another EKG and or 24 hour portable heart bp and pulse monitor.

In my opinion anyone who has high blood pressure, CAD or other heart related conditions should have EKG within 60 days prior to starting treatment.
Report any concerns during treatment. You can always ask about another EKG if still concerned.

[hepcandme]

Everything is more difficult with heart disease

Still, very sad for the patient's family. I feel fortunate that my ticker is doing fine - so far

[jules2551]

Doesnt every drug that is advertised always have a "black box"warning? Look at previous triple therapy.  Look at all the drugs advertised on TV. "May cause death"

If you BP rises please go to Dr.  But cone on folks..give and take situation

Have you seen the side effects for Viagra?

[dontworry_behappy1]

Gilead "Support Path" has a 24 hour Nurse you can call about Harvoni.  

[AWorriedMom]

Gilead Warning of Hep C Patient Death on Heart Med Will Have “Zero Impact”

By  ED SILVERMAN

Associated Press
Late last week, Gilead Sciences issued an alert about using its Sovaldi and Harvoni hepatitis C treatments along with another medicine used for treating irregular heart rates in life-threatening situations. Why? The combination of the Gilead drugs and the heart med, amiodarone, caused nine cases of seriously slow heart rates, including one fatality, and some patients required a pacemaker.

The disclosure is sending Gilead shares down, reflecting concerns that sales of its blockbuster hepatitis C drugs may take a revenue hit, especially given that a fatality was reported. But Wall Street analysts are pooh-poohing the possibility. The news will have “zero impact” on sales, Evercore ISI Mark Schoenebaum writes us.

There are several reasons. Leading the list is the likelihood that a relatively small number of hepatitis C patients are also treated with amiodarone. About 250,000 to 300,000 patients in the U.S. are treated with amiodarone at any point in time, according to Sanford Bernstein analyst Geoff Porges.

“There may be some slight overrepresentation of the very sickest hepatitis C patients [those with liver failure] in this population, but these numbers are likely to be small and not a significant proportion of total amiodarone” usage, he writes in an investor note. “Overall, it is hard for us to imagine that much more than 0.5% of [hepatitis C] patients are taking this medication.”

Using his estimate, anywhere from 1,000 to 1,500 hepatitis C patients may have been taking this combination of medicines. This amounts to a sliver of the estimated 3.2 million Americans believed to be infected with hepatitis C. Porges also notes that most of the cases of seriously slow heart rates occurred in France, where amiodarone is more widely prescribed.

But will this revelation give AbbVie, which recently began selling the rival Viekira Pak hepatitis C treatment, an edge? Porges he points out that the risks of using the heart drug is already noted in labeling for Viekira Pak. “It’s hard to make the case that AbbVie’s drug is any safer for the few HCV patients taking amiodarone than Sovaldi and Harvoni,” he writes.

[dontworry_behappy1]

"I felt for awhile something wasn't right
___________________

My blood presure was like yours and I felt weird.   Better after getting a prescription of blood preasure medication to bring my blood preasure down to
120/70.   After my Hepatitis C treatment I started feeling weird like my heart was swishing when pumping.   It was new.   Didn't go away and I experienced an weird afib experience that required my heart to be shocked back in rhythm.  

You have good insurance now.   Don't mess around with the heart issues.  have your cardo issues checked out.   I would!

[dontworry_behappy1]

Your blood preasure is higher than it should be but not much.   Regardless, you should she your doctor about that. I take medication to keep pluse
down in the 60s.   It's like that all the time.  So medication can do this.   I don't chop wood but do many labor related tasks everyday.   You shouldn't be chopping wood and over exerting yourself while taking a heavy drug therapy like this.   Especially when all the side effects are unknown.  

FYI:  I chopped some wood a few months ago....hard work!   Rest Carl.

[AWorriedMom]

Carlhcv  
3 hours
To: All
I think I may be having an issue related to bradycardia. I took 3 bp/pulse readings at rest and got 147/89 55bpm, 144/87 58bpm and 138/91 55bpm. I have been short of breath, achy and easily fatigued. I only take valium besides the Harvoni. Should I be concerned? Gonna check again right now: consecutive readings: 165/83 62bpm and 164/73 56 bpm. I have felt for awhile that something isn't right.

[dontworry_behappy1]

If it's  66 during exercise ......what is your resting rate?   What is it laying down calmly?

[AWorriedMom]

Carl, give your doc a call. No reason to wait on this. It will put your mind at ease or catch this early if he thinks it is a problem.

Rbeth, great info on the drug. Thanks.

[Carlhcv]

I did an experiment. I jumped up and went outside and split some firewood and carried in a load. Breathing very heavily and took immediate bp readings and got 181/96 66bpm,170/64 60 bpm and 175/85 60 bpm. It seems like my heart rate should have risen more.

[Carlhcv]

I think I may be having an issue related to bradycardia. I took 3 bp/pulse readings at rest and got 147/89 55bpm, 144/87 58bpm and 138/91 55bpm. I have been short of breath, achy and easily fatigued. I only take valium besides the Harvoni. Should I be concerned? Gonna check again right now: consecutive readings: 165/83 62bpm and 164/73 56 bpm. I have felt for awhile that something isn't right.

[Dee1956]

Really good catch, thanks for sharing!

[CoWriter]

Amiodarone lowers the heart rate.  So taking it together with Harvoni can lower the heart rate even more (bradycardia) which can be very serious.  

Co

[Rbeth]

Hey Jimmy,
Again, thanks for posting new FDA update and letter, from Gilead to healthcare providers.

I was able to access both easily on:

hepatitiscnewdrugs.blogspot.com

[Rbeth]

Amiodarone is a class III antiarrhythmic agent used for various types of cardiac dysrhythmias, both ventricular and atrial. It was discovered in 1961. Despite relatively common side-effects, it is used in arrhythmias that are otherwise difficult to treat with medication.The FDA was reluctant to officially approve the use of amiodarone, since initial reports had shown increased incidence of serious pulmonary side-effects of the drug. In the mid-1980s, the European pharmaceutical companies began putting pressure on the FDA to approve amiodarone by threatening to cut the supply to American physicians if it was not approved. In December 1985, amiodarone was approved by the FDA for the treatment of arrhythmias.[6] This makes amiodarone one of the few drugs approved by the FDA without rigorous randomized clinical trials.[citation needed]

- class lll antiarrhythmic

Thanks for post Jimmy.

[AWorriedMom]

Amiodorone is a drug that is used to treat people who have severe heart rhythm problems in the lower ventricles of the heart. It is not a drug that is used frequently as its use is only in people whose life is being threatened by arrythmias.

[susan400]

What is Amiodorone?  What does it do and what class of drugs is it in? Just wondering because sometimes there may be other drugs in that same class of drugs that may also have the same effect?  Please advise.  Susan400

[patra_]

Wow!  Good information!  Thanks for the Heads Up!

Pat