Navigation Links
FDA Warns Users on Psoriasis Drug
Date:2/19/2009

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 ConsumerLab.com 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:
*Name:
*Comment:
*Email:
Related Image:
FDA Warns Users on Psoriasis Drug
(Date:2/12/2016)... ... February 12, 2016 , ... Mystic Buddha Publishing House ... Blue SKies Buddha, the biography of Rama - Dr. Frederick Lenz. , ... the love of a Buddhist teacher for teaching and helping others. Valentine’s Day ...
(Date:2/12/2016)... ... 12, 2016 , ... CDRH Enforcement Trends: , Back to the Future , Feb. 25, 2016 ... Winston Churchill said, “Those who don’t learn from history are doomed to repeat it.” , ... come knocking this year. But that takes time. , Take a close look at ...
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker ... Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and ... hydrated before the big event. The invitation-only gifting suite, held this year at the ...
(Date:2/12/2016)... ... February 12, 2016 , ... Every winter, someone is killed, ... the West Penn Burn Center, part of the Allegheny Health Network, has ... bring you the “Space Heaters Need Space” campaign. , “Space Heaters Need ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Vail knee ... Industry Physician Leaders to Know in 2016 . The list consists of physicians establishing, ... physicians to establish this list. , An Ambulatory Surgery Center, also known as ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... 2016 The primary goal of this research ... on the usage of liquid biopsy. Key information the ... - Timeframe of liquid biopsy adoption amidst future users ... organization type - Sample inflow to conduct liquid biopsy ... serum, and so on. - Correlation analysis of sample ...
(Date:2/11/2016)... (NasdaqCM: PDEX) today announced financial results for its fiscal 2016 ... its Quarterly Report on Form 10-Q for the second quarter ... today. --> --> Quarter ... --> Net sales for the three months ended December ... from $2.8 million for the three months ended December 31, ...
(Date:2/11/2016)...  Kindred Biosciences, Inc. (NASDAQ: KIN ), a ... of pets, today announced the submission to FDA of ... Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).  Positive topline ... for the control of pyrexia (fever) in horses were ... --> The Chemistry, Manufacturing, and Controls ...
Breaking Medicine Technology: