Affymax May Face Class Action Lawsuits Over Omontys Recall

Affymax May Face Class Action Lawsuits Over Omontys Recall

By Mike Holter

California drug maker Affymax Inc. suffered a major blow last month when it issued a voluntary recall of its anemia drug Omontys following reports of severe allergic reactions in some kidney-disease patients, including about 5 deaths.

The small biotechnology firm developed Omontys to compete with Amgen Inc.’s blockbuster Epogen, which holds a near-monopoly in the anemia drug market. Affymax partnered with Japanese-based Takeda Pharmaceuticals to sell the drug in the United States. Omontys was promoted as a cheaper and more convenient alternative to Epogen and was used in dialysis clinics run by Fresenius Medical Care and DaVita HealthCare Partners.

Fresenius treats about one-third of all U.S. kidney-dialysis patients and said it administered the drug to about 18,000 patients before the Omontys recall. The company is already facing massive legal troubles following its own recall of its dialysis products GranuFlo and NaturaLyte, which have been linked to at least 900 deaths.

About 25,000 patients overall have been treated with Omontys since it was released to the market in March 2012, according to Affymax. Of these, approximately 50 patients experienced some type of serious hypersensitivity reaction and about 5 patients died.

Some of the affected patients developed anaphylaxis, an acute allergic reaction that can cause hives, swelling of the tongue and loss of consciousness. Without immediate medical attention, anaphylaxis can lead to death.

The FDA said it received 19 reports of anaphylaxis from U.S. dialysis centers, and that multiple patients had to be revived by doctors.

Symptoms of anaphylaxis include:

• Rapid, weak pulse
• Skin rash
• Hives
• Flushed or pale skin
• Nausea
• Vomiting
• Diarrhea
• Throat or tongue swelling
• Anaphylaxis
• Heart Attack
• Stroke
• Metabolic Alkalosis
• Low Blood Pressure
• Cardiopulmonary Arrest
• Cardiac Arrhythmia

If you or someone you love was treated for anemia at a kidney dialysis center and suffered one of these side effects, you may be eligible to participate in a free class action lawsuit investigation.

Claims are being prepared now and attorneys are actively searching for victims affected by the Omontys recall. Visit the Omontys Recall Class Action Lawsuit Investigation for more information.

Updated March 20th, 2013

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