Aa
From FDA - New Interferon Warnings
Several serious events have been identified in recent months related to reported experiences with alpha interferon products. Labeling for alpha interferon products has been updated in order to incorporate each of these class safety issues into all product labels.
Each approved alpha interferon product will now include statements regarding possible risk of
•stroke
•serous retinal detachment
•peripheral neuropathy
•pulmonary hypertension
Each approved alpha interferon product will now include statements regarding possible risk of
•stroke
•serous retinal detachment
•peripheral neuropathy
•pulmonary hypertension
I experienced eye issues (blind spots, dark spots, blurry vision) about 3 months into treatment. Doing a web search indicated that these problems had been identified but at the same time my physician(s) felt that examination by an ophthalmologist was necessary. The latter probably learned as much as I did and most of the primary literature that we were able to find indicated that the vision/eye symptoms associated with interferon have been known for some time and most are reversible post treatment. I am now about 2 months post treatment and the most annoying lingering side effect is vision. It is still blurry and the "cotton wool spots" are still visible. I visited the ophthalmologist a couple of times just after treatment and she suggested waiting for a few more months before doing anything (such as upgrading my corrective lenses which were prescribed in November of last year). So to answer the question just above this one: the "new" information is slightly more detailed than what I was initially told but consistent with what I read when the cotton wool spots first appeared. I will wait patiently until December when the next viral load check will indicate how successful treatment has been and decide at that time if they indicate that the virus has not been eliminated, whether or not I should start treatment again. Probably consistent with most people, I did not enjoy taking interferon/ribavarin in anyway. It had serious negative impact on my personal and professional life and if I had to decide right this instant, I don't think that I could deal with all of the side-effects again. So maybe I have already made a decision.
I have a history of retina problems. None of my Dr's, or nurses at the major university I am getting TX at said anything about Peg, co Peg and retina problems, but I found studies my self and went to the top retina Dr at UCLA, Jules Stein Eye Institute. Everyone needs a base line eye exam for reference. Jules Stein told me to come back for another exam at week 12 and If my retinas look as good as baseline I will have no problems and not need another exam for a year. The lessen here is not to over react to any of this, just get checked and listen to and watch your body.
From the rest of the comments I see here and the PM's that accumulated in my mailbox while I was out today, I can see that most people do appreciate the info.
Those who know me personally know that it bothers me when I make decisions to share some of the information I find because I don't like to frighten people needlessly. And like some of you pointed out, you walk a fine line.
Susan, forgive me if I misread your post. I do see you said thank you. But it struck me as as facetious comment since you said at the end of your post " I just fail to see where this information is helpful to people who are already halfway through there treatments. All it does is cause fear. Thanks for pointing that out.... " My belief is that it is helpful to people on treatment so that they may be very aware of what is going on and what they should not ignore when new symptoms appear. So again, I apologize and I certainly accept your apology.
Those who know me personally know that it bothers me when I make decisions to share some of the information I find because I don't like to frighten people needlessly. And like some of you pointed out, you walk a fine line.
Susan, forgive me if I misread your post. I do see you said thank you. But it struck me as as facetious comment since you said at the end of your post " I just fail to see where this information is helpful to people who are already halfway through there treatments. All it does is cause fear. Thanks for pointing that out.... " My belief is that it is helpful to people on treatment so that they may be very aware of what is going on and what they should not ignore when new symptoms appear. So again, I apologize and I certainly accept your apology.
This information has come from an FDA newsfeed on adverse events attributed to prescribed medications.
This was issued to subscribers to Hepatitis reslated alerts.
Their are simlar alerts being issued continuously on all medical conditions-the FDA is obliged to place reports of new adverse events in the public domain.
If we saw them all from arthrititis to irritable bowel medications we would never take anything.
Interferon is no more or less hazardous than before-if a catrastophic outbreak of attributable serious events was reported or a new and unacceptable risk confirmed the drug would simply be withdrawn.
Don't worry-interferon is just as bad for you as it's ever been!
This was issued to subscribers to Hepatitis reslated alerts.
Their are simlar alerts being issued continuously on all medical conditions-the FDA is obliged to place reports of new adverse events in the public domain.
If we saw them all from arthrititis to irritable bowel medications we would never take anything.
Interferon is no more or less hazardous than before-if a catrastophic outbreak of attributable serious events was reported or a new and unacceptable risk confirmed the drug would simply be withdrawn.
Don't worry-interferon is just as bad for you as it's ever been!
Yes, this is good information to know. The risks are great indeed.
How do you get on this FDA hepatitis alert?
frijole
How do you get on this FDA hepatitis alert?
frijole
"I just fail to see where this information is helpful to people who are already halfway through there treatments. All it does is cause fear."
I think knowing the truth about the treatment drugs is always helpful. Fear can sometimes be an approppriate response. I like to know as much about meds as possible and if information is available, I want it - even if is does make me uncomfortable or afraid, knowing is better than not knowing.
I think knowing the truth about the treatment drugs is always helpful. Fear can sometimes be an approppriate response. I like to know as much about meds as possible and if information is available, I want it - even if is does make me uncomfortable or afraid, knowing is better than not knowing.
Did I not say.... Thanks for the info...., that's what I read that I wrote. I certainly apologize for my 'different perspective' that I posted. Once again, thanks for the info. I never said, Jenny Penny, do not post information that you receive, did I say that? I was just playing devil's advocate by showing a flip side to the coin. I did not mean to rub you in the wrong way and if I have, I am so sorry. Susan400
Thanks for the info, i think its important for people to be informed of the possible sx effects of these meds. It worries me when i read where those with little to no damage jump into to tx because they just want rid of this without knowing in some cases the 40 to 50% cure rate might be worse.
I really don't think one can compare taking inteferon and Riba for an extented time to popping a couple aspirin and tylenol here and there. As for what we read on these boards is a whole lot different then what Doctors that specialize in Hepatitis and liver problems see daily.
Its my opinion that a geno 1 with little damage should really look at these new drugs that might cut tx time in half so one is not exposed as long to these meds. Everything in life as risks, just try to limit the risk any way you can.
I really don't think one can compare taking inteferon and Riba for an extented time to popping a couple aspirin and tylenol here and there. As for what we read on these boards is a whole lot different then what Doctors that specialize in Hepatitis and liver problems see daily.
Its my opinion that a geno 1 with little damage should really look at these new drugs that might cut tx time in half so one is not exposed as long to these meds. Everything in life as risks, just try to limit the risk any way you can.
It is a fine line to walk, we don't want to scare people but we have to be able to talk about things as they exist and as they come up. "
Like in the past few months I"ve become so aware to people who all of a sudden develop an allergy to Benedryl............to me that's just the most bizarre thing of them all. Definite rescue from the rescue needed as FLGuy said.
My mother lost all of her skin to a disease cause Stephens Johnson Syndrome - all of it and was in the burn unit for six months wrapped in gauze all from an antibiotic. It can happen from anything at any time.
They told her now even the SUN could trigger another attack.
At some point in time you have to responsibly weigh options and make decisions about everything in life.
As long as you dn't take an aspirin with a coke though you should probably be ok ;)
Like in the past few months I"ve become so aware to people who all of a sudden develop an allergy to Benedryl............to me that's just the most bizarre thing of them all. Definite rescue from the rescue needed as FLGuy said.
My mother lost all of her skin to a disease cause Stephens Johnson Syndrome - all of it and was in the burn unit for six months wrapped in gauze all from an antibiotic. It can happen from anything at any time.
They told her now even the SUN could trigger another attack.
At some point in time you have to responsibly weigh options and make decisions about everything in life.
As long as you dn't take an aspirin with a coke though you should probably be ok ;)
Please, post information that becomes available to you. I personally really appreciate latest scientific data. I am sure, many others do too. Thank you very much.
People here may have all kinds of different opinions, but don't let it stop you from posting.
People here may have all kinds of different opinions, but don't let it stop you from posting.
I commented in a manner that may suggest this is scary. I don't mean to make this so, or more than it already is.
I think that it is crucial to know of risks in advance so that one can make an informed decision about treating.
Susan made a good point about death being a very extreme possibility and that we can't get too shook up just in seeing the possibility listed.
But....there are many other side effects that visit those who treat with interferon and that are FAR more common. I know quite a few people who developed auto immune issues. These and many other issues may persist for many years after TX ends and may in some cases be permanent. I belabor this point since there are many people on this site who have been affected by a variety of symptoms and issues post TX.
I do so not to scare people who are already on treatment but to point out that for many people the PI's are very very close to approval. One could possibly cut the exposure to IFN in half while increasing the chances of a SVR at the very least by half again.
It is a fine line to walk, we don't want to scare people but we have to be able to talk about things as they exist and as they come up.
Thanks for posting the news Jenny and I apologize if I crossed any lines. This will remain a sensitive topic until there is a different form of TX, IMHO.
best,
Willy
I think that it is crucial to know of risks in advance so that one can make an informed decision about treating.
Susan made a good point about death being a very extreme possibility and that we can't get too shook up just in seeing the possibility listed.
But....there are many other side effects that visit those who treat with interferon and that are FAR more common. I know quite a few people who developed auto immune issues. These and many other issues may persist for many years after TX ends and may in some cases be permanent. I belabor this point since there are many people on this site who have been affected by a variety of symptoms and issues post TX.
I do so not to scare people who are already on treatment but to point out that for many people the PI's are very very close to approval. One could possibly cut the exposure to IFN in half while increasing the chances of a SVR at the very least by half again.
It is a fine line to walk, we don't want to scare people but we have to be able to talk about things as they exist and as they come up.
Thanks for posting the news Jenny and I apologize if I crossed any lines. This will remain a sensitive topic until there is a different form of TX, IMHO.
best,
Willy
Wherever you look in the realm of hcv treatment danger lurks. Peg, riba, the new stuff. There's even a possibility that one may need to be rescued from the 'rescue' drugs (reference the warnings associated with Procrit and the icky side of filgrastim). No doubt, a risk-reward proposition that needs to be fully considered before embarking on a treatment plan of any kind.
Like you, I've done every intereron known to man and didn't have a problem until last summer when I had 0 neutrophils. It seems to me from some of the questions we get around here people do not know when to call their physicians. How many people experience eye problems and come here and ask about them? I posted this stuff to make people aware of what could happen. Could happen, not do happen.That 1 in 10,000 does happen to 1 person. That is where this information may help. I wasn't born under a rock susan. I am well aware of what these warnings mean and how often they happen.
Holy cow, Susie; please continue to post stuff like this; it's important to be informed--
Bill
Bill
Listen, I am NOT trying to scare anyone half to death. I am sharing information that was sent to me by the FDA. If you don't want to read the latest up-to-date info, don't read it. But plenty of people like to be in the loop. If you want to stick your head in the sand, go right ahead. The censoring on this site by some of you is appaling to me. I think this will be the last time I will share anything I receive.
For Willy. There is no link but here is the entire email I received.
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
Several serious events have been identified in recent months related to reported experiences with alpha interferon products. Labeling for alpha interferon products has been updated in order to incorporate each of these class safety issues into all product labels.
Each approved alpha interferon product will now include statements regarding possible risk of
stroke,
serous retinal detachment,
peripheral neuropathy,and
pulmonary hypertension.
The following revisions represent the safety labeling changes:
Addition of the term serous retinal detachment to WARNINGS/Ophthalmologic Disorders.
Addition of the term pulmonary hypertension to WARNINGS/Pulmonary Disorders.
Addition of the following subsections to WARNINGS:
Peripheral Neuropathy
Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of telbivudine and pegylated interferon-alfa 2a as compared to telbivudine alone. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Cerebrovascular Disorders
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including [drug name]. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.
In addition, the following has been added to the Medication Guide for each approved interferon product:
What is the most important information I should know about [drug name] therapy?
Body organ problems: [drug name] may cause lung problems including: trouble breathing, pneumonia, inflammation of lung tissue, and new or worse high blood pressure in the lungs (pulmonary hypertension), which can be severe and lead to death. Cases of weakness, loss of coordination and numbness due to stroke have been reported in patients taking [drug name], including patients with few or no expected risk factors for stroke.
Eye problems: Changes in vision such as a decrease or loss of vision (blindness) may happen in some patients. You should have an eye exam before you take [drug name]. If you have eye problems or have had them in the past you may need eye exams while you are taking [drug name]. Tell your healthcare provider or eye doctor right away if you have any changes in your vision while taking [drug name].
What are the possible side effects of [drug name]?
Nerve problems. People who take [drug name] or other alpha interferon products with telbivudine (TYZEKA) can have nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy). Call your healthcare provider if you have any of these symptoms.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
For Willy. There is no link but here is the entire email I received.
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
Several serious events have been identified in recent months related to reported experiences with alpha interferon products. Labeling for alpha interferon products has been updated in order to incorporate each of these class safety issues into all product labels.
Each approved alpha interferon product will now include statements regarding possible risk of
stroke,
serous retinal detachment,
peripheral neuropathy,and
pulmonary hypertension.
The following revisions represent the safety labeling changes:
Addition of the term serous retinal detachment to WARNINGS/Ophthalmologic Disorders.
Addition of the term pulmonary hypertension to WARNINGS/Pulmonary Disorders.
Addition of the following subsections to WARNINGS:
Peripheral Neuropathy
Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of telbivudine and pegylated interferon-alfa 2a as compared to telbivudine alone. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Cerebrovascular Disorders
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including [drug name]. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.
In addition, the following has been added to the Medication Guide for each approved interferon product:
What is the most important information I should know about [drug name] therapy?
Body organ problems: [drug name] may cause lung problems including: trouble breathing, pneumonia, inflammation of lung tissue, and new or worse high blood pressure in the lungs (pulmonary hypertension), which can be severe and lead to death. Cases of weakness, loss of coordination and numbness due to stroke have been reported in patients taking [drug name], including patients with few or no expected risk factors for stroke.
Eye problems: Changes in vision such as a decrease or loss of vision (blindness) may happen in some patients. You should have an eye exam before you take [drug name]. If you have eye problems or have had them in the past you may need eye exams while you are taking [drug name]. Tell your healthcare provider or eye doctor right away if you have any changes in your vision while taking [drug name].
What are the possible side effects of [drug name]?
Nerve problems. People who take [drug name] or other alpha interferon products with telbivudine (TYZEKA) can have nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy). Call your healthcare provider if you have any of these symptoms.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
These seem like the same old risks that I was notified well before I started treatment five years ago and none of them have happened. IN fact in the five plus years I've been in here you rarely see anything like this and certainly not death.
Interferon like ALL drugs (including aspirin and tylenol and ibuprofen) can cause serious life treatening complications. Antibiotics can kill you more easily than you realize.
But end stage liver disease and cirrhosis can kill you too. I think everyone just needs to temper their knowledge of what "could" happen with what likely 'will' happen.
I agree with Susan 110%.
Interferon like ALL drugs (including aspirin and tylenol and ibuprofen) can cause serious life treatening complications. Antibiotics can kill you more easily than you realize.
But end stage liver disease and cirrhosis can kill you too. I think everyone just needs to temper their knowledge of what "could" happen with what likely 'will' happen.
I agree with Susan 110%.
Thanks for the info..., however, if a treatment does become available to me, with using interferon, I'll still do it. I've already used interferon 10 different treatments and I've never gotten anything even remotely like this. If you read the inserts on most drugs they list every side effect known to man, that doesn't mean that every person will get those side effects. I've be a total mental wreck if I worried about every medication I've had to take and the rare, but potential side effects. I'd never even take an antibiotic, or the flu shot, or even an aspirin..., or any other of a ga-zillion drugs that are out there both prescription and non-prescription. Actually, did you know that inteferon could cause death? In about 1 in 2,000,000 cases?? I just fail to see where this information is helpful to people who are already halfway through there treatments. All it does is cause fear. Thanks for pointing that out....
Thanks for the update. I wish that we had a link.
Am I to understand that whereas we have known that these issues have may have been aware of but NOW they are being definately linked with the use of interferon. They are therefore now adding these to the "black box" warnings and they hadn't appeared there earlier.
I am interested in seeing such things printed. This news is a double edged sword, I think; both good and bad news.
The good news is that the end user is now better informed. The bad news is that it may leave those treating less protected than ever.
That means if someone treats and experiences these symptoms or the end result the company can in effect say; "well, we warned you." I think it may relieve them of the responsibility for the issue when and where it manifests.
Am I summarizing this incorrectly?
It's really more of a question than a statement.
best,
Willy
Am I to understand that whereas we have known that these issues have may have been aware of but NOW they are being definately linked with the use of interferon. They are therefore now adding these to the "black box" warnings and they hadn't appeared there earlier.
I am interested in seeing such things printed. This news is a double edged sword, I think; both good and bad news.
The good news is that the end user is now better informed. The bad news is that it may leave those treating less protected than ever.
That means if someone treats and experiences these symptoms or the end result the company can in effect say; "well, we warned you." I think it may relieve them of the responsibility for the issue when and where it manifests.
Am I summarizing this incorrectly?
It's really more of a question than a statement.
best,
Willy
Hi, Stacy—
Did you have a baseline eye exam? They’ve known about IFN and eye problems for a long time now; here’s what Schering-Plough says about the situation:
Ophthalmologic disorders
Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, and papilledema may be induced or aggravated by treatment with peg-intron alpha 2b or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting disorders (e.g. diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Pegintron alpha 2b should be discontinued in patients who develop new or worsening ophthalmologic disorders.
www.spfiles.com/pipeg-intron.pdf
Other than that, are you doing OK?
Bill
Did you have a baseline eye exam? They’ve known about IFN and eye problems for a long time now; here’s what Schering-Plough says about the situation:
Ophthalmologic disorders
Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, and papilledema may be induced or aggravated by treatment with peg-intron alpha 2b or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting disorders (e.g. diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Pegintron alpha 2b should be discontinued in patients who develop new or worsening ophthalmologic disorders.
www.spfiles.com/pipeg-intron.pdf
Other than that, are you doing OK?
Bill
me too. my eyes are bugging me as well. little spots in my vision for like 4 days now.
geeez, my eyes have been sooo bad. I'm going to make an appointment with the eye doctor as soon as possible.
Drat! Had peripheral neuropathy (which nurse had never heard of) and vitreous detachment which is being watched for retinal detachment. They also doubted that could be connected to IFN. At least these unfortunate side effects will now appear on the label and give the doctrors a head's-up to be watching for them and not look at us like we're crazy if we report them.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
