All drugs are monitored rigidly, even after having been approved by FDA, for reported adverse effects and drug interactions. It is duty of every practitioner to report – both to the manufacturer and FDA – any unreported adverse effect (maybe in one patient) for rational monitoring and necessary action.

Team@CMHF

April 22, 2011 — The US Food and Drug Administration (FDA) has issued its latest list of drugs to monitor after having identified potential signs of serious risks or new safety information in the agency’s Adverse Event Reporting System (AERS).

he quarterly watch list consists of 9 medications that treat conditions ranging from arthritis to schizophrenia. The agency is studying them to determine whether they are causally linked to the possible risks reported through AERS from October 1, 2010, through December 31, 2010. If a link is established, the FDA then would consider some form of regulatory action, such as revising the drug’s label information, requiring a Risk Evaluation and Mitigation Strategy (REMS), or gathering more data to better characterize the risk.

Read more: http://www.medscape.com/viewarticle/741392?src=mpnews&spon=34