Health Highlights: Oct. 17, 2008

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

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.

WHAT TO KNOW
    • Democratic Fundraiser Gets Unapproved Multiple Myeloma Drug
    • Psoriasis Drug Raptiva Gets Black Box Warning on Infections
    • Recalled Cribs Pose Suffocation and Entrapment Hazard
    • 'Stayin' Alive' May Help Save Lives
    • Social Security Benefits to Rise 5.8% in 2009

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.

-----

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.

-----

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.

Page
  • 1
  • |
  • 2
Join the Discussion
blog comments powered by Disqus
 
You Might Also Like...
See It, Share It
PHOTO: Anthony Lemons glances to family and friends at the Cuyahoga County Common Pleas Court
Marvin Fong/The Plain Dealer/AP Photo
PHOTO: Indian Christian devotees watch a fireworks display outside St. Peters Church in Allahabad on Dec. 24, 2014, on Christmas Eve.
Sanjay Kanojia/AFP/Getty Images
Newborns at this hospital on Christmas Day get the special stockings as a keepsake.
Magee-Womens Hospital at the University of Pittsburgh Medical Center
PHOTO: US President Barack Obama plays golf at Mid-Pacific Country Club in Kailua, Hawaii, in this file photo.
Jewel Samad/AFP/Getty Images