The Irish drug maker, Elan, has received a subpoena from the United States Securities and Exchange Commission seeking information related to its multiple-sclerosis drug, Tysabri. Back in July 2008, Elan and its marketing partner, Biogen Idec Inc. notified regulatory agencies of two confirmed cases of a rare infection of the brain known as “progressive multifocal leukoencephalopathy” (PML) in MS patients taking the drug. Tysabri had been taken off the market years ago due to its dangerous side effects, but it was then re-launched with Elan and others monitoring its side effects very closely.
Tysabri received FDA approval in 2006 as a monotherapy (not to be used in combination with another disease-modifying therapy) for the treatment of patients with relapsing forms of MS to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. Because of Tysabri’s link to PML, this drug has generally only been recommended for patients who cannot tolerate alternate MS therapies.
Tysabri is given to patients once every four weeks by IV infusion.
The FDA prescribing information does include a black box warning about the risk of PML. PML usually leads to death or severe disability. PML symptoms include:
Clumsiness
Progressive weakness on one side of the body
Changes in thinking, memory, and orientation
Confusion
Though Tysabri had a black box warning about the risk of PML, you may be entitled to monetary compensation if you or a loved one has taken this drug and suffered from these very serious adverse effects.
If you have taken Tysabri or some other dangerous drug, please contact the defective drug attorneys at Jacoby & Meyers, LLC today to schedule a confidential consultation.
