Nearly 1/3 of all medications approved by the FDA pose safety risks identified only after approval

Posted by Sarah Showard | May 12, 2017 | 0 Comments

The Washington Post (5/9, McGinley, 11.43M) recently reported on a study published in the Journal of the American Medical Association suggesting that “almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval.” 222 products were reviewed that had been approved between 2001 and 2010 and followed them through February of this year. They found that for 32% of the medications evaluated, “the FDA took some kind of action to deal with safety issues that emerged after approval.” 4.2 years was the median time for the FDA to either withdraw the drug or issue a boxed warning or safety communication after the drug was approved.

Fortune (5/9, Entis, 7.12M) reports that the study “found drugs that went through an accelerated approval process were associated with higher rates of post market safety issues.”

Kaiser Health News (5/9, Lupkin, 2K) reports that FDA spokesperson Angela Hoague said the FDA is reviewing the study, saying, “In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.


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