Posts Tagged “drug safety”

Just noticed that the FDA started a page this week to warn consumers as well as the health care professionals that serve them to help with drug safety.

As you know there is a lot of concern about drug interactions and you need to be careful about these interactions as well as concern over labeling that may not be clear enough. Here are a few things that the FDA will be helping warn us about.

• Drug labeling, including patient labeling, professional labeling, and patient package inserts;
• Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
• A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug’s safety, efficacy, or optimal use;
• Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial’s purpose, who may participate, locations, and useful phone numbers;
• Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
• Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA’s Adverse Event Reporting System (AERS);
• Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
• Regulations and guidance documents;
• Consumer information about using medications safely and disposing of unused medicines;
• Instructions how to report problems to the FDA through its MedWatch program;
• Consumer articles on drug safety; and
• The FDA’s response to the Institute of Medicine’s 2006 report on the future of drug safety.

You cn get to the new site at FDA Drug safety.