Health Highlights: Oct. 17, 2008
Oct. 18 -- 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.
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.
