A Sea Change at FDA?
In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.
The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)
- Rituximab (marketed as Rituxan): [Progressive Multifocal Leukoencephalopathy (PML)]
- Modafinil (marketed as Provigil): [Serious Skin Reactions]
- Temozolamide (marketed as Temodar): [Aplastic Anemia]
- Deferasirox (marketed as Exjade) -recently approved new molecular entity
Find thousands of Bilingual jobs at LatPro.com.
Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.
The newsletter is available at The FDA website. Also, it will be sent electronically to those who subscribe to the Drug Safety Newsletter or to the MedWatch E-list.
To subscribe to this publication directly, go to the Drug Safety Newsletter section of the FDA site, enter your name and e-mail address in the appropriate fields, and select the "Join the List" button. Hopefully, this new publication will inform consumers about the potential adverse effects and side effects of marketed prescription medications.
Until next time.....
Good Luck and Good Job Hunting!!!!!!!!!!!
