FDA and SAEC Release First Data on Genetic Basis of ADEs

• Recommended FDA GMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Updated July 1, 2025

The original links broke.

You can still read about the same topic here:

FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events - Pharmaceutical Online

---  the original post follows below  ---

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events. The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions. “We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events. 

Additional Information: 

• For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org. 
• For information on the FDA’s Critical Path Initiative see
  https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiative

Return Home: http://drughealth.blogspot.com/ 

FDA Warning On Weight Loss Products

• Trusted FDA GMP online training courses and programs sold by SkillsPlus International Inc.

Updated December 28, 2021

The links in the original post broke.

You might also be interested in:

Tainted Weight Loss Products - FDA.gov

---  the original post follows below  ---

No doubt we'll have overeaten on Christmas, and we'll continue to do so through the holidays. Then in the new year, we'll all be tempted to lose some weight. We'll schedule workouts at the gym, go on diets, and start taking weight loss products. But stop and read before you take those weight loss products, warns the FDA, as reported in a recent American Society of Health-System Pharmacists (ASHP) daily news briefing. In general, the FDA "has listed more than 25 weight loss products to avoid, because they contain ingredients that are not labeled, and could cause serious health problems." Some of the ingredients illegally contain drugs that should be sold by prescription only. The news briefing suggests the following links for further reading . . . Are you planning to take weight loss pills? 

Bloomberg News - Illegal Weight Loss Pills May Cause Heart Attacks 

FDA News - FDA Warns Consumers About Tainted Weight Loss Pills 

AP News - FDA warns against some diet pills sold on the Web 

HealthDay - FDA Warns About Weight Loss Products 

Chicago Tribune - FDA warnings for 30 diet drugs 

WebMD - FDA Warns of Risky Weight Loss Pills 

Return Home: http://drughealth.blogspot.com/