"U.S. Food & Drug Administration (FDA)" - New class safety labeling updates for alpha interferon products

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:

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