FDA Approves First Bone Marrow Stimulator To Treat Immune-Related Low Platelet Counts

�The U.S. Food and Drug Administration approved Nplate (romiplostim), the first merchandise that directly stimulates the bone vegetable marrow to bring forth needed platelets in patients with a rare blood disorder that can jumper lead to serious bleeding.


The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low telephone number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often ineffective to remunerate for this loss.


"This product is important in that it offers a new glide slope to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, M.D., conductor, Center for Drug Evaluation and Research, FDA.


The estimated 140,000 citizenry with chronic ITP are prone to bruising and at risk for life-threatening bleeding. Current medical intervention includes corticosteroids and immune gamma globulin. Surgery to remove the spleen, a procedure known as a splenectomy, may help some patients. Nplate is approved only for patients with chronic ITP who do not respond sufficiently to current treatments.


FDA based its blessing on two randomized clinical trials of about one hundred twenty-five patients world Health Organization had standard at least one prior ITP treatment. One study enrolled patients who still had their spleen, the other enrolled patients wHO did non.


During sise months of treatment, patients who received Nplate had significantly higher platelet counts and kept up those higher counts compared to those who did not have the drug. The response to Nplate was higher in those patients world Health Organization still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not welcome Nplate, but one experienced a sustained increase in platelet counts.


Safety concerns with Nplate include unchewable deposits in the bone marrow and the possibility that at one time Nplate is stopped, blood platelet counts could drop down the stairs what they were in front beginning intervention.


Additional risks include blood clots due to inordinate increases in platelets and, if Nplate were disposed to patients with an abnormal rakehell condition known as myelodysplasia, a danger for a form of blood malignant neoplastic disease known as acute leukaemia. Myelodysplasia, which is associated with low platelet counts, predisposes some patients to leukemia. In a study of 44 patients wHO had myelodysplasia and received Nplate, four patients developed leukemia. Further clinical trials in patients with predisposing conditions for leukemia will be required to determine whether the development of leukemia may relate to the use of Nplate. Nplate is approved only for habit among patients with chronic ITP.


A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of Nplate therapy. Under the Food and Drug Administration Amendments Act of 2007, FDA has determined that a REMS is necessary for the benefits of Nplate to outweigh the risks of the product. The REMS will include a Medication Guide for patients and requires that all prescribers and patients enroll in a special program to track the long term safety of Nplate therapy.


Nplate is manufactured by Amgen, Inc. of Thousand Oaks, Calif.

http://www.fda.gov


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Artist: Chris Glassfield

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 Reflexology

   Year: 2004   
Tracks: 10


   
 Music For Relaxation

   Year: 2002   
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 Ballerina

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 Born Free Classics No.1

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 Wintertime

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 Libra

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Tracks: 11


   
 Gentle Moods

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Scars of Life

   
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Rock
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 What We Reflect

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 Another Tomorrow

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Tracks: 6

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Portishead 'will not play live again in 2008'

Portishead have revealed that they will not play any further live shows in 2008.

Speaking to BBC6Music, the band's guitarist Adrian Utley said that their recent gig at the Bacelona Forum would be the comeback outfit's last this year.

"I don't think we are going to be doing any more gigs this year," he said. "But we'll possibly do some next year."

Utley went on to talk about the fact that Radiohead have recently been covering their song 'The Rip' during soundchecks.

He said: "I know [about the cover version] because Colin [Greenwood, bassist] from the band emailed me to say they had been playing it," he said. "�And that they'd put it up on their site of them playing it in the dressing room.

"Thom [Yorke, vocals and piano] sounds beautiful singing it, it was amazing, such a buzz."

Video footage of Radiohead covering 'The Rip' by Portishead is available to watch on the Radiohead website now.

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 Last Rites

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Mendes leaves rehab but will return

Mendes leaves rehab but will return

Actress Eva Mendes has left the rehab clinic where she was existence treated in ordering to attend to to some "personal stage business".
US media reports suggest that the star has been in the Cirque Hunting lodge in Mormon State for several weeks now.
Mendes' instance said: "Eva is attendance to or so personal business in Los Angeles and intends to return to complete her discussion shortly."
It was announced before in the week that the actress was in a rehab clinic attendance to "personal issues".
A spokesperson said: "Eva has been working hard for the past year and made a positive degree decision to take some much-needed time off to proactively attend to some personal issues that, spell not critical, she felt deserved approximately exterior master support."