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U.S. Department of Health and Human Services

For Consumers

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FDA Launches Drug Safety Newsletter

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PDF Cover Image - Drug Safety Newsletter - Fall 2007Spread the word to your health care providers: The Food and Drug Administration has launched the first issue of the Drug Safety Newsletter, a quarterly publication designed to raise awareness about reported adverse events and stimulate more reporting. An adverse event report is a communication to FDA of an undesirable sign or symptom associated with a drug.

Who is the newsletter for?

Physicians, physician assistants, nurses, pharmacists, dentists, other allied health care professionals, health professional associations, and drug information centers.

What does it cover?

  • Findings of selected post-marketing drug safety reviews
  • Data from reports submitted to FDA's Adverse Event Reporting System
  • Information on new and emerging drug safety issues
  • Listings of recent public health advisories and information sheets

What's in the first issue (Fall 2007)?

  • Reports of a rare condition called progressive multifocal leukoencephalopathy associated with the use of Rituxan (rituximab), a medication to treat people with non-Hodgkins lymphoma and rheumatoid arthritis
  • Reports of serious skin reactions associated with Provigil (modafinil), a medication to treat excessive sleepiness caused by certain sleep disorders
  • Reports of aplastic anemia associated with Temodar (temozolomide), a drug used to treat certain types of brain cancer
  • An overview of adverse events associated with Exjade (deferasirox), an oral chelating agent used to treat iron overload due to multiple blood transfusions
  • Recent drug safety advisories posted in FDA's Web site

How is the newsletter distributed?

Date Posted: September 21, 2007