FDA Launches Drug Safety Newsletter
Spread 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?
- On the Web: FDA's Drug Safety newsletter is available on FDA's Web site at http://www.fda.gov/FDAgov/Drugs/DrugSafety/DrugSafetyNewsletter/default.htm
- Through E-lists: People who subscribe to the Drug Safety Newsletter E-list or the MedWatch E-list will receive an e-mail message whenever a new issue is available online.
Date Posted: September 21, 2007