Skip to Content

FDA says 3 deaths associated with Genentech drug

February 19, 2009

WASHINGTON (AP) – Three patients taking a Genentech drug are believed to have died of a rare brain infection, a known risk with the skin-clearing treatment, according to federal health officials.

The Food and Drug Administration on Thursday confirmed three cases and a possible fourth of progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and is usually fatal. All the cases were reported in the last six months.

The FDA announcement came the same day that European Union regulators recommended a ban on marketing the drug. The European Medicines Agency stated “the benefits of Raptiva no longer outweigh its risks, because of safety concerns.”

The drug is marketed in Europe by Swiss drugmaker Merck Serono.

The FDA said two U.S. patients who were diagnosed with the disease died, as did the additional patient who was believed to have the disease, but was never diagnosed.

Genentech previously notified physicians and investors of the cases.

“We take the risk of PML very seriously and are working diligently with the FDA to put the right plans in place that will help protect patient safety,” said company spokeswoman Tara Cooper.

First approved in 2003, Raptiva is a once-a-week injection used to treat red, scaly skin caused by psoriasis.

The FDA in October added its most serious warning to Raptiva, after a 70-year-old patient caught PML and died after taking the drug for four years.

The agency stressed in a statement posted to its Web site Thursday that patients should be aware of the symptoms of the infection, which include weakness, blurred vision and difficulty speaking. Doctors should likewise monitor patients taking the drug for these signs, the FDA said.

PML is typically seen in patients with weakened immune systems, and previously has been reported in patients taking Rituxan, a blockbuster arthritis and cancer drug marketed by Genentech and Biogen Idec.

Shares of Genentech added 27 cents to $84.97 in afternoon trading.

Copyright 2009 The Associated Press.

Keep Reading

Most Popular

A Roomba recorded a woman on the toilet. How did screenshots end up on Facebook?

Robot vacuum companies say your images are safe, but a sprawling global supply chain for data from our devices creates risk.

A startup says it’s begun releasing particles into the atmosphere, in an effort to tweak the climate

Make Sunsets is already attempting to earn revenue for geoengineering, a move likely to provoke widespread criticism.

10 Breakthrough Technologies 2023

Every year, we pick the 10 technologies that matter the most right now. We look for advances that will have a big impact on our lives and break down why they matter.

These exclusive satellite images show that Saudi Arabia’s sci-fi megacity is well underway

Weirdly, any recent work on The Line doesn’t show up on Google Maps. But we got the images anyway.

Stay connected

Illustration by Rose Wong

Get the latest updates from
MIT Technology Review

Discover special offers, top stories, upcoming events, and more.

Thank you for submitting your email!

Explore more newsletters

It looks like something went wrong.

We’re having trouble saving your preferences. Try refreshing this page and updating them one more time. If you continue to get this message, reach out to us at customer-service@technologyreview.com with a list of newsletters you’d like to receive.