Are you taking Tysabri? read FDA warning

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Message: 1 Date: Tue, 22 Sep

2009 07:14:17 -0500 (CDT) Subject: MedWatch - Natalizumab (marketed as Tysabri)

- FDA continues to receive reports of progressive multifocal leukoencephalopathy

(PML)

Audience: Neurological healthcare professionals, patients

[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal

leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved

by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in

November 2004 and for moderately to severely active Crohn's disease in January

2008.

From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13

reported cases of Tysabri-related PML were confirmed worldwide in patients being

treated for MS with Tysabri monotherapy. There have been no postmarketing

reports of PML in patients treated with Tysabri for Crohn's disease. Less than

2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based

on available data from the U.S. and outside of the U.S., the current rate of PML

in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per

1,000 patients.

The risk for developing PML appears to increase with the number of Tysabri

infusions received. At this time, the FDA is not requiring changes regarding PML

to the Tysabri prescribing information or to the Tysabri risk management plan,

called the TOUCH Prescribing Program.

Read the MedWatch safety summary, including a link to the " Information for

Healthcare Professionals " page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm182667.htm

Message: 2 Date: Thu, 24 Sep

2009 22:22:53 -0500 (CDT) Subject: Tamiflu (oseltamivir) for Oral Suspension:

Medication dosing errors reported