Drug Safety Information

The objective of this study is Drug Safety Information. We use the term emerging drug safety information to describe information FDA is monitoring or analyzing that may have the potential to alter the benefit/risk analysis for a drug in such a way as to affect decisions about prescribing or taking the drug 

FDA considers many factors in the course of evaluating an emerging drug safety concern and deciding whether emerging drug safety information should be made available to the public. These factors include, but are not limited to, the following:

• Reliability of the data
• Magnitude of the risk
• Seriousness of the event (e.g., severity and reversibility) relative to the disease being treated Plausibility of a causal relationship between the use of a drug and the adverse event
• Extent of patient exposure (e.g., how broadly is the drug used)
• Potential to prevent or mitigate the risk in the patient population (e.g., monitoring)
• Effect on clinical practice
• Disproportionate impact on particular populations (e.g., children or the elderly)

FDA issues Public Health Advisories (PHAs) to provide information regarding important public health issues to the general public, including patients and healthcare professionals. For example, PHAs may:

• Highlight important safety information about a drug
• Inform the public about the status of FDA’s evaluation of an emerging drug safety issue
• Announce the implementation of a Risk MAP for a drug
• Advise the public regarding a manufacturer’s suspension of marketing of a drug due to safety concerns
• Provide other important public health information

In the U.S., the government's Food and Drug Administration (FDA) must approve any drug before it can be sold. This is true whether it's a prescription or an over-the-counter drug.

Authors can share their research in our journal through online portal by using this link: https://www.longdom.org/submissions/advances-pharmacoepidemiology-drug-safety.html  and through email :  adpharma@eclinjournals.com and  through twitter also https://bit.ly/3c5AfuB

With Regards,

Sarah Johnson

Editorial Assistant

Advances in Pharmacoepidemiology and Drug Safety