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Warnings strengthened for Tysabri

-Pharmacy News

10/29/2009 - A growing association between a widely used multiple sclerosis drug Tysabri (natalizumab) and a potentially deadly brain infection has been reflected in strengthened warnings for prescribers and patients.

The Therapeutic Goods Administration (TGA) today announced that it would update warnings for Tysabri after the European Medicines Agency (EMEA) started an investigation into the drug's link to progressive multifocal leukoencephalopathy (PML).

"While it was known that this medicine is associated with a rare infection of the brain, it is becoming likely that the incidence of this infection increases with increasing duration of use of natalizumab," the TGA said in a statement.

"The Australian product information and consumer medicines information documents are being updated to reflect this new information."

According to EMEA, there have been 23 cases of PML associated with Tysabri throughout the world since 2006.

In July, the drug's manufacturer Biogen Idec revealed that there had been 10 cases of PML linked to Tysabri since 2006, which suggests there had been 13 more cases in less than half a year.

"This review is initiated to discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment," EMEA said.

The US Food and Drug Administration (FDA) said last month that it continued to receive reports of PML, with the current rate of the infection in patients who took at least 24 infusions of Tysabri ranging from 0.4 to 1.3 per 1,000 patients.

The Tysabri warning comes days after the FDA highlighted an increased risk of developing PML by patients taking rheumatoid arthritis drug Mabthera (rituximab) while, earlier this year, fears of a link to PML lead to the withdrawal of psoriasis drug Raptiva from the Australian market.

The TGA said it had not received any reports of PML linked to the use of Tysabri in Australia and the drug's current boxed warnings had for "several years" warned prescribers about the link to PML.

If you or a loved one have experienced Raptiva Side Effects such as progressive multifocal Leukoencephalopathy (PML) you may be entitled to compensation. Contact the Raptiva Lawyers of Ennis & Ennis, P.A. today about a potential Raptiva Side Effects Lawsuit. Our experienced attorneys can answer any questions you may have about Raptiva side effects, a potential Raptiva class action lawsuit, or PML.