Navigation Links
FDA Warns Users on Psoriasis Drug

Three have died from rare brain infection while taking Raptiva, officials report in health advisory

THURSDAY, Feb. 19 (HealthDay News) -- U.S. health officials issued a public health advisory Thursday for the psoriasis drug Raptiva after confirming that three people using the medication have died.

Two of three people with confirmed cases of a rare brain infection called progressive multifocal leukoencephalopathy (PML) are among the dead, according to the U.S. Food and Drug Administration advisory. The third death was a person believed to have contracted the brain infection, according to the advisory.

All four had been treated with Raptiva (efalizumab) for at least three years, and none was taking other immune suppressants.

In its advisory, the FDA said it would study the issue carefully and "strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment."

"Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms," the advisory recommended.

Outside experts, however, said that, though the news was serious, there was no reason to panic.

"Patients should talk to their doctors and carefully weigh the risks and benefits of Raptiva, taking into account the most recent bit of information," said Bruce Bebo Jr., director of research for the National Psoriasis Foundation in Portland, Ore. "The risk to folks in the grand scheme of things is still not very high. For some patients, this [and similar drugs] have very profound efficacy. Psoriasis is a life-changing disease for many people, and a lot of people are willing to accept that degree of risk."

Srikanth Kolluru, an assistant professor of pharmaceutical sciences at Texas A&M Health Science Center, said that people "who are on this medication currently should be made aware that it might cause brain infection [PML] or any other infections and possible symptoms so that they can contact their physician immediately."

People using the drug "need to be well-informed about the symptoms for PML infection and need to be monitored closely," he said.

Meanwhile, European regulators on Thursday called for sales of Raptiva to be suspended, Bloomberg news reported. In an e-mail cited by Bloomberg, the regulators said that "the benefits of Raptiva no longer outweigh its risks, because of safety concerns."

Raptiva, a once-weekly injection, suppresses the immune system to reduce psoriasis flare-ups, but this can increase the risk of serious infections and malignancies, experts noted. PML is caused by a virus.

Psoriasis is an autoimmune disease that usually shows up on the skin and can also manifest as psoriatic arthritis, according to the National Psoriasis Association.

Tysabri (natalizumab), a drug used to treat multiple sclerosis, also carries risk for PML, according to the FDA. And other biologics approved for psoriasis carry risks. Enbrel, for instance, will now carry a black-box warning noting the risk of serious infections.

In fact, a study reported last year found that almost one-quarter of biologic therapies approved in the United States and Europe since 1995 have been the subject of at least one safety-related regulatory action in the decade since they were approved. In October, the FDA mandated that Raptiva carry a black-box warning about the risk of life-threatening infections, including PML.

That announcement came on the heels of news from California-based drug maker Genentech, which makes Raptiva, that a 70-year-old patient taking the drug died after developing PML. At the time, it was the only confirmed case of PML in someone taking the drug, Bloomberg reported.

The black-box warning also notes the risk of serious infections -- such as viral meningitis, bacterial blood infections and invasive fungal disease -- that have led to hospitalizations or deaths in people taking Raptiva. Previously, those warnings were listed in an unboxed section on the drug's labeling.

Genentech also added warnings of neurological conditions noted in people taking Raptiva, Bloomberg reported. The conditions include Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, transverse myelitis and facial palsy. Those warnings will not be boxed.

More information

Here's more on the FDA health advisory on Raptiva.

SOURCES: Srikanth Kolluru, Ph.D., assistant professor, pharmaceutical sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Kingsville, Texas; Bruce Bebo Jr., Ph.D., director, research, National Psoriasis Foundation, Portland, Ore.; Feb. 19, 2009, statement, U.S. Food and Drug Administration

Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Warns of Codeine Risk for Some Nursing Mothers
2. PA Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Perry County Dairy
3. Research warns that human papillomavirus might cause bladder cancer
4. New research warns of the lack of specialization when judging individuals with mental disorders
5. Coalition of Caregivers Warns Congress of Danger to Oldest U.S. Seniors if Medicare Slashed
6. Health Department Warns Consumers of Home-Canned Soup Linked to Potter County Restaurant
7. FDA Warns Against Bio-Identical Hormone Therapy
8. Cold Meds Not Safe for Kids Under 2, FDA Warns
9. FDA Warns Clot Risk Higher in Birth Control Patch Than Pill
10. Renaissance Health Publishing, LLC Warns the Public that is Not Independent and Labels the CL Seal of Approval a Worthless, Paid-For Advertising Gimmick
11. Health Capital Group Warns of Fallout to Hospitals From the Subprime Mortgage Crisis and Urges Hospitals to Immediately Reassess Existing Debt Structures and Capital Financing Plans
Post Your Comments:
Related Image:
FDA Warns Users on Psoriasis Drug
(Date:11/25/2015)... ... , ... Beddit® has launched a new Android app for use ... a more intuitive SleepScore™ that rates sleep quality on a 100-point scale and makes ... by a proprietary algorithm. Beddit analyzes the data to provide an easy to understand ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
(Date:11/25/2015)... ... 2015 , ... Many people know of the common symptoms of low thyroid ... skin. But many people who find their cholesterol levels and weight are creeping up ... especially if they don’t have any of the other symptoms. , Thyroid hormone plays ...
(Date:11/24/2015)... ... 2015 , ... Genesis Chiropractic Software helps practice owners automate ... between the practice owner and the patient that automatically manages all five aspects ... Click here to learn more. , According to Dr. Brian ...
(Date:11/24/2015)... Dallas, Texas (PRWEB) , ... November 24, 2015 , ... ... of all charitable donations are made in the last five weeks of the year ... #GivingTuesday was created in 2012 to connect the nation’s charities with those individuals who ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015 Research and Markets ( ) ... - Global Forecast to 2020" report to their ... for 37.21% of the total market share in 2014. ... region is projected to growth at the highest CAGR ... primarily to the fast growing water, industrial gas treatment, ...
(Date:11/24/2015)... 25, 2015 WuXi PharmaTech (Cayman) Inc. ("WuXi" ... open-access R&D capability and technology platform company serving the ... China and the ... extraordinary general meeting of shareholders held today, the Company,s ... and approve the previously announced agreement and plan of ...
(Date:11/24/2015)... N.C. , Nov. 24, 2015  In the ... projects in an effort to quickly uncover new insights, ... --> --> However, ... a market research project and ensure that all rules ... and industry standards. Another major barrier to efficiently launching ...
Breaking Medicine Technology: