FDA Requires Updated Labeling for Interferon Alpha Products Due to Recent Identi

[willy]

Here's the latest update.  I don't know if you've heard about this yet but this article has a summary of the main points.  It isn't that the drug has changed but rather they have been able to prove a few more lesser known or un-proven issues.- Willy
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http://www.hivandhepatitis.com/hep_b/news/2009/090409_a.html

FDA Requires Updated Labeling for Interferon Alpha Products Due to Recent Identified Safety Issues

On September 1, 2009 the U.S. Food and Drug Administration (FDA) announced that label warnings for interferon alpha products were updated to reflect some newly recognized safety issues, namely stroke, retinal detachment, peripheral neuropathy, and pulmonary hypertension. Pegylated interferon alpha (Pegasys or PegIntron) is standard treatment for hepatitis C, and pegylated or conventional interferon are used for hepatitis B.

Below is the text of an announcement from the FDA explaining the changes.

FDA Hepatitis Update: New class safety labeling updates for alpha interferon products

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:
   Disorders.
   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 [Tyzeka]. 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.

9/04/09

Source
R Klein and K Struble (Food and Drug Administration). New class safety labeling updates for alpha interferon products. FDA Hepatitis Update. September 1, 2009.

[Hank's mom]

Thank you Willy for passing this on.

It is interesting to me that though my doctors are top of the mark both on the "liver floor" who were my Hep C team, I only found out some of the issues listed in your post when I was put on the tp list.  This actually came about particularly because the tp team had me go for every update on it seemed every issue a body can have. This may have been explained in the tp orientation which I couldn't attend without a "buddy" much like Lamaze, my sis-in-law is going to come with me to the next one, since she has moved up on my proxy as my soon to be totally exed ex has slipped to 5th place.  (I may just sit up and pull the plug or march out of there on pure attitude before it takes 5 to make a decision. Sorry bout the tangent.)
My eye doctor explained about the retinal issues, as well as other peripheral problems.  

I actually shared the reading of the side effects insert that came with the peg-interferon and riba - a good eye test if there ever was one, there was no direct wording concerning these issues.

Susie


I think this latest adjustment is the honest reality of treatments being works in progress.  Did the pharms and the FDA know these sides already?  I don't know if it would have made a difference.  By that I mean that trial drugs have either failed or haven't always been the answer, nor was infergen which is no longer recommended.  Goodness knows, as those of who were put on infergen, that was a real slap in the face, kick in the butt, and several body shots, hooks and jabs fight we had to somehow live through only to find out it was no longer the way to go.