PML & FDA Warnings

Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection linked to certain diseases of the immune system and to immunosuppressive drugs prescribed to treat a variety of immune system disorders.

Drug Warnings Related to PML

The U.S. Food and Drug Administration (FDA) has issued numerous announcements and warnings about a variety of drugs for treating immune system disorders. These drugs include Tysabri®, Rituxan™, Raptiva® and transplant drugs.


Tysabri® is in a class of medications known as immunomodulators. The drug stops certain cells in the immune system from damaging the body. It was approved in November 2004 for treating multiple sclerosis and in January 2008 for treating moderately to severely active Crohn's disease.

In April 2011, the FDA reported it had updated the Tysabri® label to say that the more of the drug that was given, the greater the risk of developing PML. The FDA also warned that the risk of PML increases if certain immunosuppresants have been taken in the past before taking Tysabri®. These immunosuppresants included mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate. Patients and doctors are warned to be alert to symptoms of PML.


Rituxan™ is prescribed to treat rheumatoid arthritis, systemic lupus erythematosus, and non-Hodgkin's lymphoma. Drug makers Biogen Idec and Genentech issued in October 2009 a letter to healthcare professionals, providing new safety information regarding the medication and PML. "The information to date," the letter stated, "suggests that patients with RA (rheumatoid arthritis) who receive Rituxan™ have an increased risk of PML."

The letter went on to say that physicians should be alert to PML in their patients taking Rituxan™ who develop new symptoms of problems with the brain and nervous system. To make a diagnosis, the physician should consult with a neurologist, do a magnetic resonance image (MRI) of the brain, and a lumbar puncture to test for the presence of the JC virus, the infection that causes PML.


Raptiva®, approved by the FDA in 2003, is prescribed to treat moderate to severe plaque psoriasis. In February 2009, the FDA and Genentech, Raptiva®'s manufacturer, issued a public health advisory to warn healthcare professionals of three confirmed cases and one possible other occurrence of PML in patients using Raptiva®.

On April 8, 2009, the FDA and Genentech issued a joint notification to healthcare professionals of a voluntary, phased withdrawal of Raptiva® because of the risk of PML in patients taking the drug. By June 8, 2009, the drug was off the market. Physicians were warned to be alert to symptoms of PML in their patients who took the drug.

Transplant Drugs

The FDA in April 2008 announced it was conducting a safety review of CellCept (made by Hoffman-LaRoche, Inc.) and Myfortic (made by Novartis Pharmaceuticals, Inc.) to find out if the drugs, used to suppress the immune system after organ transplantation, were linked to PML. It advised healthcare professionals to be alert to the symptoms of PML in patients on the organ transplant medications.

In February 2009 the FDA and Roche Laboratories notified health care providers that a CellCept Medication Guide would be distributed with every prescription in language that patients could easily understand. In March 2009 the FDA and Novartis notified healthcare professionals that a Myfortic Medication Guide would be distributed with the medication in language easily understandable to patients.

PML Symptoms

  • Progressive problems with walking
  • Progressive weakness of the arms
  • Difficulty with balance
  • Problems speaking
  • Problems understanding what others are saying
  • Problems with vision
  • Personality changes
  • Clumsiness
  • Decline in mental abilities

If you are taking any of the drugs mentioned above and you experience symptoms of PML, you should seek medical attention right away. You might be eligible for compensation if a diagnosis is made. To schedule a free and confidential evaluation of your case, contact us today.

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