Democratic Fundraiser Gets Unapproved Multiple Myeloma Drug
Despite a drug maker's refusal to grant permission, a prominent Democratic fundraiser is being treated with a drug that's unapproved to treat multiple myeloma.
A "legal basis" was found that cleared the way for the drug Tysabri to be given to 61-year-old Fred Baron, who has late-stage multiple myeloma, his son Andrew Baron said in an email to the Associated Press. The drug was obtained through the Mayo Clinic, which consulted with the U.S. Food and Drug Administration.
Biogen Idec Inc, which makes Tysabri, didn't approve Baron's use of the drug because the regulatory risks of giving him special access to the drug are too great, said company spokeswoman Naomi Aoki.
Tysabri has been approved by the FDA to treat Crohn's disease or multiple sclerosis. The drug's use to treat multiple myeloma is in the early clinical trial stage, the AP reported.
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Psoriasis Drug Raptiva Gets Black Box Warning on Infections
The psoriasis drug Raptiva must now carry a black box warning -- the most serious kind -- about the risk of life-threatening infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML), the U.S. Food and Drug Administration said Thursday.
Earlier this week, California-based drug maker Genentech said a 70-year-old patient taking Raptiva died after developing PML. A Genentech spokeswoman told Bloomberg news it was the only confirmed case of PML in a patient taking Raptiva.
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 patients taking Raptiva. Previously, those warnings were listed in an unboxed section on the drug's labeling.
Raptiva suppresses the immune system in order to reduce psoriasis flare-ups, but this immune system suppression can increase the risk of serious infections and malignancies in patients, the FDA said.
Genentech also added warnings of neurological conditions noted in patients taking Raptiva, Bloomberg reported. The conditions include Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, transverse myelitis, and facial palsy. Those warnings won't be boxed.
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Recalled Cribs Pose Suffocation and Entrapment Hazard
A suffocation and entrapment hazard that caused the death of a child has prompted the recall of about 2,000 Playkids convertible cribs, the U.S. Consumer Product Safety Commission said Thursday. The sides of the crib are made of mesh that expands, creating a gap between the mattress and the side.
On Aug. 31, a 5-month-old child in Brooklyn, N.Y., became trapped between the crib mattress and drop side rail and suffocated.
This recall involves made-in-China convertible crib/playpen/bassinet/bed with model number PLK-909. "Playkids U.S.A." can be found on the packaging and on a label sewn into the side of the crib, and the model number can be found on the packaging, the CPSC said. The cribs have a drop side rail, a stationary side rail, a canopy assembly, and a bassinet. The sides of the crib, the mattress support, the bassinet, the canopy and the bedskirt are covered in fabric and mesh, which come in a variety of colors and patterns.
The cribs were sold in juvenile product stores in New York from March 2007 through September 2008 for about $100. Consumers should stop using these cribs and contact Playkids USA of Brooklyn, N.Y., at (718) 797-0302 to receive a full refund.
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'Stayin' Alive' May Help Save Lives
The classic disco tune "Stayin' Alive" has almost the perfect beat for people doing CPR chest compressions, according to University of Illinois medical school researchers. The song has 103 beats per minute, while the American Heart Association recommends 100 chest compressions per minute for CPR.
In this study, 15 students and doctors first did CPR on mannequins while listening to "Stayin' Alive." They were told to time chest compressions with the song's beat, the Associated Press reported. Five weeks later, the same participants repeated the drill without the music, but were told to play the famous Bee Gees song in their head, while they did chest compressions.
The average number of compressions in the first session was 109 per minute, and 113 per minute in the second session. That's more than recommended by the AHA, but a few extra compressions are better than too few when trying to restart a stopped heart, said study author Dr. David Matlock, the AP reported.
He plans to present the study this month at an American College of Emergency Physicians meeting.
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Social Security Benefits to Rise 5.8% in 2009
A 5.8 percent increase in Social Security benefits next year means the average retiree will receive an additional $63 per month, the U.S. government announced Thursday.
The increase, based on rises in the Consumer Price Index, is the largest since a 7.4 percent boost in 1982 and more than double the 2.3 percent increase this year, the Associated Press reported.
More than 55 million Americans will benefit from next year's cost of living increase, including more than 50 million on Social Security, and others who receive Supplemental Security Income payments for the poor.
The typical monthly Social Security check for one person will go from $1,090 to $1,153 per month, while the average couple receiving Social Security benefits will see an increase of $103 a month to $1,876, the AP reported.
A couple receiving the standard Supplemental Security Income payment will go from $956 to $1,011 per month, while the monthly SSI payment for an individual will go from $637 to $674 per month. The average monthly check for a disabled worker will go from $1,006 to $1,064 per month.
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