Psoriasis medication recall - Raptiva

[asterroc]

If you or anyone you know is currently taking Raptiva (efalizumab) for psoriasis, it is currently being withdrawn from the market due to fatal viral infections and brain damage as a side effect. Raptiva suppresses the immune system. Around 70-90% of the population has a virus called the JC virus dormant in their bodies, and when Raptiva suppresses the immune system this virus can become active. When it does so, it causes progressive multifocal leukoencephalopathy (PML), which is similar to MS and causes inflammation of the brain.

If you're using Raptiva (or have in the past), please talk to your doctor ASAP about how to best wean yourself off of it and about your risk factors for PML.

Below is the email the makers of Raptiva are sending out to patients.

---------- Forwarded message ----------
From: Do Not Reply <donotreply@hhemail.genentech.com>
Date: Thu, Apr 30, 2009 at 3:34 PM
Subject: VOLUNTARY MARKET WITHDRAWAL OF RAPTIVA® (efalizumab)


April 2009

Dear :


This message from Genentech is intended for patients currently being treated with RAPTIVA.

Patient safety is a top priority for Genentech. Since September 2008, Genentech has received 3 reports of progressive multifocal leukoencephalopathy (PML), a serious and almost always fatal brain infection caused by a virus, in patients taking RAPTIVA. Because of the following key aspects of PML and our commitment to safety, Genentech has decided to voluntarily stop selling RAPTIVA.

Although we believe that there are many psoriasis patients who benefit from RAPTIVA, there is no way to know ahead of time who will get PML.

There is no treatment or cure for PML. People who do live with PML are severely disabled.

What You Need to Do

Do not stop your RAPTIVA treatment without first talking to your doctor. Stopping RAPTIVA may lead to serious side effects, such as severe worsening of your psoriasis and, in some cases, has led to hospitalization.

Call or make an appointment to discuss other psoriasis treatment options with your doctor as soon as possible. Pharmacies will only refill prescriptions until Monday June 8, 2009. It is important that you have enough time to plan a change to another treatment before stopping RAPTIVA.

For the limited amount of time that you may still be taking RAPTIVA, it is important that you read the Medication Guide that comes with your medication. Before each injection, read the Medication Guide, which explains serious side effects of RAPTIVA. You should discuss these side effects with your doctor.

This information does not take the place of talking with your doctor about your condition or treatment. Additional information including a copy of the RAPTIVA US Prescribing Information and Medication Guide can be found at www.raptiva.com. Please speak to your doctor about any questions or concerns you may have.

Thank you for your prompt attention to this letter.

We also want you to be aware that the Clearly You and Raptiva Support Communication Programs, which were designed to help you manage your
therapy, are being discontinued. Please discuss your future therapy management plans with your healthcare provider.

You are receiving this information based on your current or past usage of RAPTIVA or request for more information on RAPTIVA.

If you prefer not to receive future E-mail click here.
To view our permission marketing policy click here.
For full prescribing information including Medication Guide click here.



What is RAPTIVA?

RAPTIVA is a prescription medicine used to treat adults with the type of psoriasis that is not adequately treated with medicines that go on the skin.

RAPTIVA has not been studied in children under 18 years of age.

RAPTIVA has serious side effects that can lead to death:

Serious side effects with RAPTIVA include Progressive Multifocal Leukoencephalopathy (PML), serious infections, nervous system disorders, worsening of psoriasis, cancer, low platelet counts (thrombocytopenia), low blood counts (anemia), and arthritis. PML is a serious brain infection caused by a virus. PML results in death or severe disability. Using RAPTIVA will increase your risk for PML. Raptiva has also been associated with serious infections caused by bacteria, fungi and viruses that have led to hospitalization or death. Before you start using RAPTIVA, tell your doctor if you have an infection. Do not use RAPTIVA if you have a serious infection.
Stopping RAPTIVA may lead to serious side effects, such as severe worsening of your psoriasis that can lead to hospitalization. Tell your doctor if you want to stop using RAPTIVA so that you and your doctor can carefully plan how to change to another psoriasis medicine.
The most common side effects of RAPTIVA usually happen within the first 48 hours after your RAPTIVA injection. Common side effects include headache, chills, fever, nausea, muscle aches.

These are not all the side effects of RAPTIVA. Read the Medication Guide that comes with RAPTIVA before you start using it and before each injection. There may be new information. This information does not take the place of talking with your doctor about your condition or your treatment with RAPTIVA. Ask your doctor if you have any questions about the Medication Guide or RAPTIVA.

Please see full prescribing information including Boxed WARNING and Medication Guide at www.RAPTIVA.com.


©2009 Genentech USA, Inc. All rights reserved. 9677700
1 DNA Way, South San Francisco, CA 94080

Comments

[l0stmyrel1g10n.livejournal.com]

Can this virus be suppressed by antiviral drugs? I'm just wondering why, if everyone has it, people who are on immune system suppressing drugs for things like organ transplants aren't affected by it.

[zandperl.livejournal.com]

According to Wikipedia it only affects people with severely compromised immune systems, primarily AIDS and organ transplant patients. One particular antiviral called HAART has proven effective against it, but it looks like others are still in the testing stage.

http://en.wikipedia.org/wiki/Progressive_multifocal_leukoencephalopathy