Thursday, September 20, 2007

Drug safety news letter from the FDA

The US FDA has launched the first issue of its new Drug Safety Newsletter this week. It will be published quarterly with the goal of keeping "our medical community posted ... about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products."

The first issue covers postmarketing surveillance data on:
- rituximab (Rituxan), an immunosuppressant used primarily to treat non-Hodgkin's lymphoma or rheumatoid arthritis: reports of progressive multifocal leukoencephalopathy associated with this agent ("rare fatal demyelinating disease that is caused by a viral infection of the brain following reactivation of the JC or BK polyomavirus (also known as papovavirus) present in about 80 percent of adults")

- modafinil (Provigil), a CNS stimulant used to treat narcolepsy, shift work sleep disorder, and sleepiness symptons associated with obstructive sleep apnea/hypopnea syndrome: reports of serious skin reactions

- temozolomide (Temodar), used to treat astrocytomas, a kind of brain tumor: aplastic anemia (bone marrow doesn't produce enough blood cells)

- deferasirox (Exjade), an oral chelating agent used to treat chronic iron overload due to blood transufions: GI, renal, and hematologic adverse events

The main newsletter page will include an archive of issues, and you can also sign up for email updates as new issues are posted.

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