Avonex Liver Damage

MS Patients who are taking the medication Avonex, an injectable medication manufactured by Biogen Idec of Cambridge, Massachusetts and approved for use in 1996, should be monitored closely for liver problems according to the manufacturer and the Food and Drug Administration (FDA). The warning states that “patients should be monitored for [liver] injury.” It goes on to state that “Hepatic Injury, including hepatic failure and elevated serum hepatic enzymes levels, has been reported in post marketing experience” with Avonex.

What the product does

Avonex belongs to the Interferon class of drugs, which as a class have shown a tendency to affect Liver function abnormally regardless of the condition being treated. Avonex was believed to have the least negative side effects on the liver of the various Interferon based treatments used for Multiple-Sclerosis.

Elevated liver enzymes are an indicator of liver damage which is easily detected in blood tests. Further, if MS patients note that they bruise easily, have dark blue-green bruises on their bodies, or the pigments of the eyes are yellow in color, this is also highly indicative of possible liver damage.

When patients were taken off Avonex in studies, their liver enzyme levels normalized, but when they were put back on Avonex, the numbers increase again.

Warnings

Biogen states that some of the cases occurred when taken in conjunction with other accepted MS treatments. The potential for liver problems should be weighed carefully by Physicians for patients with any form of hepatic disease or who may already be on a regimen of MS related pharmaceuticals, some of which may also put potentially adverse pressure on liver function. Patients who use alcohol should be carefully evaluated and monitored regularly.

The warning also notes the potential problems when using this medication in pregnant women, noting that “no studies have been done on pregnant women,” and they suggest physicians register pregnant patients on Avonex in a special “Avonex Pregnancy Registry” to be monitored by Biogen and presumably, the FDA.

Previously warnings have been issued about Avonex regarding its use with depressed patients and with patients who have heart conditions.

Interestingly, in 2001 the FDA issued a warning to Biogen warning them of consequences of continuing what the FDA termed as “misleading promotions” in regards to the promotion of Avonex. Biogen voluntarily pulled the misleading materials.

Legal Action and could you be Qualified?

When potentially life threatening side effects are discovered during “post marketing” there is a question of liability on the part of the manufacturer, and in some cases doctors who prescribe the drug without following the stated precautions or giving patients adequate warning.

Based on the information obtained to date, it appears that anyone who is currently taking Avonex alone or in combination with other medications or alcohol is at risk. Hundreds of thousands of doses of Avonex are prescribed and injected every year, and in many cases these people may have suffered liver damage. The possible effect of this medication has not even been studied on pregnant women, so the future risk to the children of these women is completely unknown.

If you or a loved one take or have taken Avonex and meet any of the criteria mentioned below:

• You have experienced high liver enzymes in blood testing
• You have been told that you have liver damage, permanent or otherwise
• You experienced or are experiencing odd bruises, yellowing of the eyes, or any other signs of liver disease
• You are pregnant and taking Avonex during your pregnancy
• You had a child (or children) with any birth defects or mental incapacity after taking Avonex during your pregnancy
• You drink alcohol and informed your doctor, who continued to prescribe Avonex
• You take other MS medications (especially Interferon based treatments) while taking Avonex
• Your doctor prescribed Avonex without describing any of it’s dangers and side effects
• The patient passed away while being treated with Avonex
Please fill out the form below and a legal practice with an interest in investigating this matter will review your complaint in consideration of possible inclusion in a potential legal action.