Tysabri FDA Warning

Since it was first approved by the Food and Drug Administration (FDA) in 2004, there have been multiple Tysabri FDA warnings issued due to findings that this powerful multiple sclerosis drug therapy may cause a severe, life-threatening, brain infection known as progressive multifocal leukoencephalopathy, or PML.

PML damages the brain’s white matter, causing a range of symptoms that vary according to the area of the brain that is injured. Generally, PML symptoms arise slowly and then progress rapidly once the condition has moved past its initial phase. Common symptoms of PML include cognitive and speech impairments, confusion, disorientation, loss of balance and vision, and/or seizures. Less than five percent of Tysabri PML patients will survive longer than one year after their diagnosis.

Generically referred to as natalizumab, Tysabri was originally sold under the brand name Antegren. Tysabri is administered to patients every 28 days via an infusion process that gradually disperses the medication. Tysabri is marketed and distributed in the U.S. by Biogen Idec and Élan. Tysabri is available in the U.S.; however, it has been pulled from the market in the past, and following its reintroduction, now has stricter Tysabri FDA warning labels placed on all of its advertising and packaging.

Tysabri FDA Warning Timeline

• 2004 – Tysabri is first approved by the FDA.
• 2005 – Biogen Idec and Élan voluntarily pull Tysabri from the U.S. due to two reports of patients developing PML.
• 2006 – Tysabri is re-launched in the U.S. with stricter protocols for administration, including a “black box” Tysabri FDA warning about PML risks that was required by the FDA.
• 2009 – With more than 30 cases of Tysabri PML being reported since 2006, Biogen Idec and Élan updated the Tysabri FDA warning label to emphasize the risks of developing PML when taking Tysabri – particularly for patients who take the drug for longer than 25 months.

Tysabri FDA Warnings and Tysabri Settlement Opportunities

The Tysabri FDA warnings may have come too late. Those who suspect that they have been injured by or suffered a loss due to Tysabri are encouraged to learn more about their legal rights and receive an expert evaluation of their case by meeting with our skilled Tysabri lawyers for a free initial consultation. Not only will experienced attorneys work on contingency, but they will also work tirelessly to help build the strongest possible case so they have the best chance at securing the maximum possible Tysabri settlement.

If you or a loved one has used Tysabri and has been diagnosed with PML, you should contact our Tysabri lawyers immediately for a free and confidential case review. You may be entitled to compensation, and we can help.